An interventional study of Northwestern University Flexible Sub-Ischial Suction Socket (NU-FlexSIS) in Amputation, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to participants aged 21 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-10.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Treatment
The objective of this pilot research project is to evaluate the effect of prosthetic socket design on amputated limb hip muscle strength and endurance in Service members, Veterans, and civilians who use above-the-knee prostheses. Traditional above-the-knee socket designs provide pelvic support that interferes with hip motion. They may also reduce the effort required from amputated limb hip muscles to stabilize the hip and amputated limb, risking further loss of muscle mass and strength beyond that due to amputation. Long-standing use of above-the-knee sockets with pelvic support may therefore intensify amputated limb muscle loss and weakness, leading to challenges with walking and balance, increasing the effort required to walk, and contributing to degenerative changes in the hips and knees. Alternative socket designs that lessen the loss of muscle mass and strength are therefore required.
The investigators have developed a new socket without pelvic support for above-the-knee prosthesis users called the Northwestern University Flexible Sub-Ischial Suction (NU-FlexSIS) Socket. This new socket design increases user comfort and is often preferred by users over sockets with pelvic support. This new socket does not lessen the mechanical function of the socket, or walking and balance performance. Our recent research suggests that walking with this new socket may also increase amputated limb hip muscle size. However, more research is needed to demonstrate that this new socket design improves amputated limb hip muscle strength and endurance, leading to better function.
A socket design that increases amputated limb hip muscle strength and endurance would provide a simple way to restore amputated limb hip muscle weakness in above-the-knee prosthesis users. Despite a considerable decrease in hip muscle size and strength due to amputation surgery, amputated limb hip muscles are expected to compensate for the loss of knee and ankle function by providing stability and propulsion during walking. Walking in the new socket design without pelvic support is expected to increase amputated limb hip muscle strength and endurance, providing an appealing alternative to traditional resistance training in order to retain hip muscle strength. Unlike traditional resistance training, using this new socket design would not require additional time or equipment, and may be effective just by walking in the home, community, or workplace. Due to existing infrastructure (e.g., ongoing clinical adoption of the NU-FlexSIS Socket, existing instructional materials and courses for fabrication and fitting of the NU-FlexSIS Socket, as well as a continuing partnership with Chicago's largest provider of prosthetic clinical care), the investigators anticipate being able to translate our research results to clinical practice by the end of the project period.
The investigators expect the results of the proposed pilot research project to directly and positively benefit the health and well-being of Service members, Veterans, and civilians who are above-the-knee prosthesis users. Benefits of increasing amputated limb hip muscle strength and endurance may include: i) improved control over the prosthesis, ii) better balance, iii) reduced effort to walk, and iv) protection against joint degeneration. For Service members these benefits could improve their performance on challenging and/or uneven ground, and increase the distance and speed they can walk or run. For Veterans, these benefits could lead to greater independence during activities of daily living, and fewer falls, reducing the physical and emotional burden on family members and caregivers.
University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: worn an ischial containment socket for ≥ 2 years, able to walk short distances (10 meters), ability to read, write, and speak English, ≥ 2 years using a liner-based suspension, and a residual limb length ≥ 5".
Exclusion Criteria: amputation of a second leg, contralateral complications (e.g., hip replacement), or other major neuromusculoskeletal or cardiovascular conditions (e.g., heart failure).
Device: Northwestern University Flexible Sub-Ischial Suction Socket (NU-FlexSIS)
The sub-ischial socket includes a firm, compressive, preferably cylindrical, fabric-covered silicone liner, a flexible inner socket, and a shorter rigid outer socket. The socket has proximal trim lines that do not impinge on the pelvis; they terminate distal to the ischial tuberosity and greater trochanter. For the NU-FlexSIS Socket, passive suction suspension is achieved using a one way valve and a liner with an internal seal. Since the prosthetic socket is a custom-made device, it is considered Class I exempt by the Food and Drug Administration (FDA).
Residual Limb Hip Muscle Peak Torque at Baseline
Hip flexor, extensor, adductor and abductor muscle strength will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular strength will be assessed via average peak torque (i.e., highest torque) across the first three repetitions of 12.
Time frame: Baseline
Residual Limb Hip Muscle Peak Torque at 8-weeks
Hip flexor, extensor, adductor and abductor muscle strength will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular strength will be assessed via average peak torque (i.e., highest torque) across the first three repetitions of 12. Comparison will be made to baseline measure.
Time frame: 8 weeks after intervention
Residual Limb Hip Muscle Peak Torque at 42-weeks
Hip flexor, extensor, adductor and abductor muscle strength will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular strength will be assessed via average peak torque (i.e., highest torque) across the first three repetitions of 12. Comparison will be made to baseline measure.
Time frame: 42 weeks after intervention
Residual Limb Hip Muscle Endurance at Baseline
Hip flexor, extensor, adductor and abductor muscle endurance will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular endurance will be assessed via a fatigue index, calculated as a percentage of the difference between total work performed during the first and last 3 repetitions divided by total work over the first 3 repetitions. A higher fatigue index will be taken as evidence of reduced muscular endurance.
Time frame: Baseline
Residual Limb Hip Muscle Endurance at 8-weeks
Hip flexor, extensor, adductor and abductor muscle endurance will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular endurance will be assessed via a fatigue index, calculated as a percentage of the difference between total work performed during the first and last 3 repetitions divided by total work over the first 3 repetitions. A higher fatigue index will be taken as evidence of reduced muscular endurance. Comparison will be made to baseline measure.
Time frame: 8 weeks after intervention
Residual Limb Hip Muscle Endurance at 42-weeks
Hip flexor, extensor, adductor and abductor muscle endurance will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular endurance will be assessed via a fatigue index, calculated as a percentage of the difference between total work performed during the first and last 3 repetitions divided by total work over the first 3 repetitions. A higher fatigue index will be taken as evidence of reduced muscular endurance. Comparison will be made to baseline measure.
Time frame: 42 weeks after intervention
Residual Limb Hip Muscle Duration at Baseline
Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The duration of time each hip muscle was active during a stride was calculated as the percentage of the gait cycle (i.e., heel-strike to heel-strike) for which that EMG signal was above a baseline value (min: 0%, max: 100%). The larger the percentage of the gait cycle that a muscle was deemed to be active, the greater its duration.
Time frame: Baseline
Residual Limb Hip Muscle Duration at 8-weeks
Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The duration of time each hip muscle was active during a stride was calculated as the percentage of the gait cycle (i.e., heel-strike to heel-strike) for which that EMG signal was above a baseline value (min: 0%, max: 100%). The larger the percentage of the gait cycle that a muscle was deemed to be active, the greater its duration.
Time frame: 8 weeks after intervention
Residual Limb Hip Muscle Duration at at 42-weeks
Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The duration of time each hip muscle was active during a stride was calculated as the percentage of the gait cycle (i.e., heel-strike to heel-strike) for which that EMG signal was above a baseline value (min: 0%, max: 100%). The larger the percentage of the gait cycle that a muscle was deemed to be active, the greater its duration.
Time frame: 42 weeks
Residual Limb Hip Muscle Integrated Area at Baseline
Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The total amount of hip muscle activity was calculated as the integrated area under the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles and multiple by 100. The integrated areas is therefore reported as a percentage of that maximum (min: 0%, max: 100%). The larger the integrated area the more the muscle was deemed to be active.
Time frame: Baseline
Residual Limb Hip Muscle Integrated Area at 8-weeks
Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The total amount of hip muscle activity was calculated as the integrated area under the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles and multiple by 100. The integrated areas is therefore reported as a percentage of that maximum (min: 0%, max: 100%). The larger the integrated area the more the muscle was deemed to be active.
Time frame: 8 weeks after intervention
Residual Limb Hip Muscle Integrated Area at 42-weeks
Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The total amount of hip muscle activity was calculated as the integrated area under the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles and multiple by 100. The integrated areas is therefore reported as a percentage of that maximum (min: 0%, max: 100%). The larger the integrated area the more the muscle was deemed to be active.
Time frame: 42 weeks after intervention
Peak Residual Limb Hip Muscle Activity at Baseline
Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The highest level of hip muscle activity was calculated as the peak of the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles recorded during baseline). The peak EMG is therefore typically reported as a value between 0 and 1. However, if the peak value during assessments increases relative to baseline, the value of the peak activity will exceed 1. The larger the peak value the greater the activation of that muscle.
Time frame: Baseline
Peak Residual Limb Hip Muscle Activity at 8 Weeks
Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The highest level of hip muscle activity was calculated as the peak of the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles recorded during baseline). The peak EMG is therefore typically reported as a value between 0 and 1. However, if the peak value during assessments increases relative to baseline, the value of the peak activity will exceed 1. The larger the peak value the greater the activation of that muscle.
Time frame: 8 weeks after intervention
Peak Residual Limb Hip Muscle Activity at 42 Weeks
Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The highest level of hip muscle activity was calculated as the peak of the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles recorded during baseline). The peak EMG is therefore typically reported as a value between 0 and 1. However, if the peak value during assessments increases relative to baseline, the value of the peak activity will exceed 1. The larger the peak value the greater the activation of that muscle.
Time frame: 42 weeks after intervention
Four Square Step Test at Baseline
A test of dynamic balance and coordination that assesses the participant's ability to step over objects forward, sideways, and backwards. Test was administered and scored as the best time (i.e., fastest) of two trials.
Time frame: Baseline
Four Square Step Test at 8 Weeks
A test of dynamic balance and coordination that assesses the participant's ability to step over objects forward, sideways, and backwards. Test was administered and scored as the best time (i.e., fastest) of two trials.
Time frame: 8-weeks after intervention
Four Square Step Test at 42 Weeks
A test of dynamic balance and coordination that assesses the participant's ability to step over objects forward, sideways, and backwards. Test was administered and scored as the best time (i.e., fastest) of two trials.
Time frame: 42-weeks after intervention
One Leg Stance Test at Baseline
A test of static balance that assesses the participant's ability to remain upright on one leg. Test was administered and scored as the best time (i.e., longest) of two trials. Longer times imply better static balance.
Time frame: Baseline
One Leg Stance Test at 8 Weeks
A test of static balance that assesses the participant's ability to remain upright on one leg. Test was administered and scored as the best time (i.e., longest) of two trials. Longer times imply better static balance.
Time frame: 8 weeks after intervention
One Leg Stance Test at 42 Weeks
A test of static balance that assesses the participant's ability to remain upright on one leg. Test was administered and scored as the best time (i.e., longest) of two trials. Longer times imply better static balance.
Time frame: 42 weeks after intervention
10-Meter Walk Test at Baseline
The 10MWT assesses walking speed in meters per second over a short duration. A faster speed is consider better walking performance. The fastest of 2 trials was used.
Time frame: Baseline
10-Meter Walk Test at 8 Weeks
The 10MWT assesses walking speed in meters per second over a short duration. A faster speed is consider better walking performance. The fastest of 2 trials was used.
Time frame: 8 weeks after intervention
10-Meter Walk Test at 42 Weeks
The 10MWT assesses walking speed in meters per second over a short duration. A faster speed is consider better walking performance. The fastest of 2 trials was used.
Time frame: 42 weeks after intervention
2-Minute Walk Test at Baseline
The 2-Minute Walk Test is a measurement of waking endurance that assesses walking distance over two minutes. A longer distance walked indicates greater walking endurance.
Time frame: Baseline
2-Minute Walk Test at 8 Weeks
The 2-Minute Walk Test is a measurement of waking endurance that assesses walking distance over two minutes. A longer distance walked indicates greater walking endurance.
Time frame: 8-weeks after intervention.
2-Minute Walk Test at 42 Weeks
The 2-Minute Walk Test is a measurement of waking endurance that assesses walking distance over two minutes. A longer distance walked indicates greater walking endurance.
Time frame: 42-weeks after intervention.
Volume of Physical Activity at Baseline
To assess the volume of physical activity, transfemoral prosthesis users wore a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from the step count data. The volume of physical activity will be quantified by the mean number of steps per activity bout. Higher values will be taken as evidence of greater physical activity.
Time frame: 2 weeks prior to intervention (baseline)
Volume of Physical Activity at 8 Weeks
To assess the volume of physical activity, transfemoral prosthesis users wore a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from the step count data. The volume of physical activity will be quantified by the mean number of steps per activity bout. Higher values will be taken as evidence of greater physical activity.
Time frame: 8-weeks after intervention
Volume of Physical Activity at 42 Weeks
To assess the volume of physical activity, transfemoral prosthesis users wore a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from the step count data. The volume of physical activity will be quantified by the mean number of steps per activity bout. Higher values will be taken as evidence of greater physical activity.
Time frame: 42-weeks after intervention
Frequency of Physical Activity at Baseline
To assess the frequency of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The frequency of physical activity will be quantified by the mean number of activity bouts per day. Higher values will be taken as evidence of greater physical activity.
Time frame: 2 weeks prior to intervention (baseline)
Frequency of Physical Activity at 8 Weeks
To assess the frequency of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The frequency of physical activity will be quantified by the mean number of activity bouts per day. Higher values will be taken as evidence of greater physical activity.
Time frame: 8 weeks after intervention
Frequency of Physical Activity at 42 Weeks
To assess the frequency of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The frequency of physical activity will be quantified by the mean number of activity bouts per day. Higher values will be taken as evidence of greater physical activity.
Time frame: 42 weeks after intervention
Duration of Physical Activity at Baseline
To assess the duration of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The duration of physical activity will be quantified by the mean time (in minutes) of activity bouts per day. Higher values will be taken as evidence of greater physical activity.
Time frame: 2 weeks prior to intervention (baseline)
Duration of Physical Activity at 8 Weeks
To assess the duration of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The duration of physical activity will be quantified by the mean time (in minutes) of activity bouts per day. Higher values will be taken as evidence of greater physical activity.
Time frame: 8 weeks after intervention
Duration of Physical Activity at 42 Weeks
To assess the duration of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The duration of physical activity will be quantified by the mean time (in minutes) of activity bouts per day. Higher values will be taken as evidence of greater physical activity.
Time frame: 42 weeks after intervention
| Milestone | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
| Milestone | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
| Milestone | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Started | 5 |
| Completed | 4 |
| Not completed | 1 |
| Withdrew: Participant experienced a heart attack | 1 |
Hip flexor, extensor, adductor and abductor muscle strength will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular strength will be assessed via average peak torque (i.e., highest torque) across the first three repetitions of 12.
| newton-meters / kg*meters | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Hip extension | 25.6 (18.9 to 32.4) |
| Hip flexion | 14.9 (7.29 to 22.6) |
| Hip abduction | 25.6 (19.0 to 32.4) |
| Hip adduction | 13.1 (8.63 to 17.5) |
Hip flexor, extensor, adductor and abductor muscle strength will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular strength will be assessed via average peak torque (i.e., highest torque) across the first three repetitions of 12. Comparison will be made to baseline measure.
| newton-meters / kg*meters | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Hip extension | 23.6 (15.2 to 31.9) |
| Hip flexion | 14.1 (8.35 to 19.9) |
| Hip abduction | 22.4 (15.4 to 29.5) |
| Hip adduction | 13.3 (7.55 to 19.1) |
Hip flexor, extensor, adductor and abductor muscle strength will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular strength will be assessed via average peak torque (i.e., highest torque) across the first three repetitions of 12. Comparison will be made to baseline measure.
| newton-meters / kg*meters | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Hip extension | 19.1 (9.12 to 29.1) |
| Hip flexion | 12.2 (3.11 to 21.2) |
| Hip abduction | 21.6 (8.77 to 34.4) |
| Hip adduction | 10.1 (5.77 to 14.5) |
Hip flexor, extensor, adductor and abductor muscle endurance will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular endurance will be assessed via a fatigue index, calculated as a percentage of the difference between total work performed during the first and last 3 repetitions divided by total work over the first 3 repetitions. A higher fatigue index will be taken as evidence of reduced muscular endurance.
| newton-meters / kg*meters | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Residual Limb Hip Muscle Endurance at Baseline | NA (NA to NA) |
Hip flexor, extensor, adductor and abductor muscle endurance will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular endurance will be assessed via a fatigue index, calculated as a percentage of the difference between total work performed during the first and last 3 repetitions divided by total work over the first 3 repetitions. A higher fatigue index will be taken as evidence of reduced muscular endurance. Comparison will be made to baseline measure.
| newton-meters / kg*meters | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Residual Limb Hip Muscle Endurance at 8-weeks | NA (NA to NA) |
Hip flexor, extensor, adductor and abductor muscle endurance will be measured in transfemoral prosthesis users using a motor-driven isokinetic dynamometer. Muscular endurance will be assessed via a fatigue index, calculated as a percentage of the difference between total work performed during the first and last 3 repetitions divided by total work over the first 3 repetitions. A higher fatigue index will be taken as evidence of reduced muscular endurance. Comparison will be made to baseline measure.
| newton-meters / kg*meters | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Residual Limb Hip Muscle Endurance at 42-weeks | NA (NA to NA) |
Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The duration of time each hip muscle was active during a stride was calculated as the percentage of the gait cycle (i.e., heel-strike to heel-strike) for which that EMG signal was above a baseline value (min: 0%, max: 100%). The larger the percentage of the gait cycle that a muscle was deemed to be active, the greater its duration.
| percentage | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Gluteus Maximus | 71.9 (52.1 to 91.6) |
| Hamstrings | 73.2 (42.0 to 100.0) |
| Gluteus medius | 76.5 (51.9 to 100.0) |
| Tensor fascia latae | 78.7 (62.2 to 95.2) |
| Rectus femoris | 81.3 (52.9 to 100.0) |
| Adductor Magnus | 72.3 (52.3 to 92.4) |
Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The duration of time each hip muscle was active during a stride was calculated as the percentage of the gait cycle (i.e., heel-strike to heel-strike) for which that EMG signal was above a baseline value (min: 0%, max: 100%). The larger the percentage of the gait cycle that a muscle was deemed to be active, the greater its duration.
| percentage | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Gluteus maximus | 64.0 (43.4 to 84.6) |
| Hamstrings | 60.7 (26.6 to 94.8) |
| Gluteus medius | 62.1 (22.5 to 100.0) |
| Tensor fascia latae | 54.0 (33.0 to 75.0) |
| Rectus femoris | 75.5 (49.7 to 100.0) |
| Adductor magnus | 68.6 (32.1 to 100.0) |
Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The duration of time each hip muscle was active during a stride was calculated as the percentage of the gait cycle (i.e., heel-strike to heel-strike) for which that EMG signal was above a baseline value (min: 0%, max: 100%). The larger the percentage of the gait cycle that a muscle was deemed to be active, the greater its duration.
| percentage | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Gluteus maximus | 60.1 (29.8 to 90.3) |
| Hamstrings | 61.1 (16.4 to 100.0) |
| Gluteus medius | 51.3 (7.96 to 94.6) |
| Tensor fascia latae | 45.1 (30.1 to 60.1) |
| Rectus femoris | 75.9 (45.5 to 100.0) |
| Adductor magnus | 53.0 (11.3 to 94.6) |
Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The total amount of hip muscle activity was calculated as the integrated area under the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles and multiple by 100. The integrated areas is therefore reported as a percentage of that maximum (min: 0%, max: 100%). The larger the integrated area the more the muscle was deemed to be active.
| percentage of maximum value | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Gluteus maximus | 23.4 (19.0 to 27.8) |
| Hamstrings | 23.6 (8.71 to 38.5) |
| Gluteus medius | 24.3 (12.5 to 36.2) |
| Tensor fascia latae | 24.0 (17.9 to 29.9) |
| Rectus femoris | 27.4 (16.3 to 38.6) |
| Adductor magnus | 20.5 (13.7 to 27.4) |
Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The total amount of hip muscle activity was calculated as the integrated area under the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles and multiple by 100. The integrated areas is therefore reported as a percentage of that maximum (min: 0%, max: 100%). The larger the integrated area the more the muscle was deemed to be active.
| percentage of maximum | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Gluteus maximus | 15.3 (3.53 to 27.1) |
| Hamstrings | 14.4 (1.88 to 27.0) |
| Gluteus medius | 28.0 (1.18 to 64.2) |
| Tensor fascia latae | 13.4 (1.39 to 25.5) |
| Rectus femoris | 24.2 (8.42 to 39.9) |
| Adductor magnus | 22.7 (2.28 to 45.8) |
Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The total amount of hip muscle activity was calculated as the integrated area under the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles and multiple by 100. The integrated areas is therefore reported as a percentage of that maximum (min: 0%, max: 100%). The larger the integrated area the more the muscle was deemed to be active.
| percentage of maximum | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Gluteus maximus | 30.9 (1.82 to 76.6) |
| Hamstrings | 21.7 (1.99 to 46.5) |
| Gluteus medius | 17.3 (1.10 to 40.6) |
| Tensor fascia latae | 7.66 (2.94 to 12.38) |
| Rectus femoris | 25.1 (5.69 to 44.6) |
| Adductor magnus | 15.2 (2.37 to 39.7) |
Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The highest level of hip muscle activity was calculated as the peak of the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles recorded during baseline). The peak EMG is therefore typically reported as a value between 0 and 1. However, if the peak value during assessments increases relative to baseline, the value of the peak activity will exceed 1. The larger the peak value the greater the activation of that muscle.
| mV | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Gluteus maximus | 1.00 (NA to NA) |
| Hamstrings | 1.00 (NA to NA) |
| Gluteus medius | 1.00 (NA to NA) |
| Tensor fascia latae | 1.00 (NA to NA) |
| Rectus femoris | 1.00 (NA to NA) |
| Adductor magnus | 1.00 (NA to NA) |
Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The highest level of hip muscle activity was calculated as the peak of the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles recorded during baseline). The peak EMG is therefore typically reported as a value between 0 and 1. However, if the peak value during assessments increases relative to baseline, the value of the peak activity will exceed 1. The larger the peak value the greater the activation of that muscle.
| mV | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Gluteus maximus | 0.51 (0.23 to 0.78) |
| Hamstrings | 0.71 (0.37 to 1.04) |
| Gluteus medius | 1.46 (0.38 to 3.30) |
| Tensor fascia latae | 0.71 (0.37 to 1.05) |
| Rectus femoris | 0.82 (0.50 to 1.14) |
| Adductor magnus | 0.90 (0.42 to 1.37) |
Electromyographic (EMG) signals were recorded from transfemoral prosthesis users' residual limb muscles while walking. The highest level of hip muscle activity was calculated as the peak of the EMG signal during a gait cycle (i.e., heel-strike to heel-strike). Each EMG signal was normalized (i.e., divided by its maximum value across all the gait cycles recorded during baseline). The peak EMG is therefore typically reported as a value between 0 and 1. However, if the peak value during assessments increases relative to baseline, the value of the peak activity will exceed 1. The larger the peak value the greater the activation of that muscle.
| mV | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Gluteus maximus | 1.33 (0.09 to 2.57) |
| Hamstrings | 0.85 (0.29 to 1.41) |
| Gluteus medius | 1.29 (0.42 to 3.00) |
| Tensor fascia latae | 0.47 (0.12 to 0.82) |
| Rectus femoris | 1.18 (0.50 to 1.86) |
| Adductor magnus | 0.65 (0.12 to 1.17) |
A test of dynamic balance and coordination that assesses the participant's ability to step over objects forward, sideways, and backwards. Test was administered and scored as the best time (i.e., fastest) of two trials.
| seconds | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Four Square Step Test at Baseline | 17.91 (6.63 to 29.2) |
A test of dynamic balance and coordination that assesses the participant's ability to step over objects forward, sideways, and backwards. Test was administered and scored as the best time (i.e., fastest) of two trials.
| seconds | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Four Square Step Test at 8 Weeks | 15.1 (5.45 to 24.8) |
A test of dynamic balance and coordination that assesses the participant's ability to step over objects forward, sideways, and backwards. Test was administered and scored as the best time (i.e., fastest) of two trials.
| seconds | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Four Square Step Test at 42 Weeks | 11.4 (7.13 to 15.7) |
A test of static balance that assesses the participant's ability to remain upright on one leg. Test was administered and scored as the best time (i.e., longest) of two trials. Longer times imply better static balance.
| seconds | Baseline Ischial Containment to Subischial Socket |
|---|---|
| One Leg Stance Test at Baseline | NA (NA to NA) |
A test of static balance that assesses the participant's ability to remain upright on one leg. Test was administered and scored as the best time (i.e., longest) of two trials. Longer times imply better static balance.
| seconds | Baseline Ischial Containment to Subischial Socket |
|---|---|
| One Leg Stance Test at 8 Weeks | NA (NA to NA) |
A test of static balance that assesses the participant's ability to remain upright on one leg. Test was administered and scored as the best time (i.e., longest) of two trials. Longer times imply better static balance.
| seconds | Baseline Ischial Containment to Subischial Socket |
|---|---|
| One Leg Stance Test at 42 Weeks | NA (NA to NA) |
The 10MWT assesses walking speed in meters per second over a short duration. A faster speed is consider better walking performance. The fastest of 2 trials was used.
| meters/second | Baseline Ischial Containment to Subischial Socket |
|---|---|
| 10-Meter Walk Test at Baseline | 0.91 (0.57 to 1.24) |
The 10MWT assesses walking speed in meters per second over a short duration. A faster speed is consider better walking performance. The fastest of 2 trials was used.
| meters/second | Baseline Ischial Containment to Subischial Socket |
|---|---|
| 10-Meter Walk Test at 8 Weeks | 1.09 (0.78 to 1.40) |
The 10MWT assesses walking speed in meters per second over a short duration. A faster speed is consider better walking performance. The fastest of 2 trials was used.
| meters/second | Baseline Ischial Containment to Subischial Socket |
|---|---|
| 10-Meter Walk Test at 42 Weeks | 1.13 (0.89 to 1.36) |
The 2-Minute Walk Test is a measurement of waking endurance that assesses walking distance over two minutes. A longer distance walked indicates greater walking endurance.
| meters | Baseline Ischial Containment to Subischial Socket |
|---|---|
| 2-Minute Walk Test at Baseline | 119 (71.1 to 167) |
The 2-Minute Walk Test is a measurement of waking endurance that assesses walking distance over two minutes. A longer distance walked indicates greater walking endurance.
| meters | Baseline Ischial Containment to Subischial Socket |
|---|---|
| 2-Minute Walk Test at 8 Weeks | 122 (61.6 to 182) |
The 2-Minute Walk Test is a measurement of waking endurance that assesses walking distance over two minutes. A longer distance walked indicates greater walking endurance.
| meters | Baseline Ischial Containment to Subischial Socket |
|---|---|
| 2-Minute Walk Test at 42 Weeks | 138 (93.3 to 182) |
To assess the volume of physical activity, transfemoral prosthesis users wore a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from the step count data. The volume of physical activity will be quantified by the mean number of steps per activity bout. Higher values will be taken as evidence of greater physical activity.
| mean number of steps per activity bout | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Volume of Physical Activity at Baseline | 27 (19 to 35) |
To assess the volume of physical activity, transfemoral prosthesis users wore a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from the step count data. The volume of physical activity will be quantified by the mean number of steps per activity bout. Higher values will be taken as evidence of greater physical activity.
| mean number of steps per activity bout | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Volume of Physical Activity at 8 Weeks | 30 (20 to 40) |
To assess the volume of physical activity, transfemoral prosthesis users wore a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from the step count data. The volume of physical activity will be quantified by the mean number of steps per activity bout. Higher values will be taken as evidence of greater physical activity.
| mean number of steps per activity bout | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Volume of Physical Activity at 42 Weeks | 34 (19 to 48) |
To assess the frequency of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The frequency of physical activity will be quantified by the mean number of activity bouts per day. Higher values will be taken as evidence of greater physical activity.
| mean number of activity bouts per day | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Frequency of Physical Activity at Baseline | 63 (48 to 78) |
To assess the frequency of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The frequency of physical activity will be quantified by the mean number of activity bouts per day. Higher values will be taken as evidence of greater physical activity.
| mean number of activity bouts per day | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Frequency of Physical Activity at 8 Weeks | 74 (62 to 86) |
To assess the frequency of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The frequency of physical activity will be quantified by the mean number of activity bouts per day. Higher values will be taken as evidence of greater physical activity.
| mean number of activity bouts per day | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Frequency of Physical Activity at 42 Weeks | 81 (68 to 93) |
To assess the duration of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The duration of physical activity will be quantified by the mean time (in minutes) of activity bouts per day. Higher values will be taken as evidence of greater physical activity.
| mean time (in minutes) of activity bouts | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Duration of Physical Activity at Baseline | 3.27 (2.87 to 3.67) |
To assess the duration of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The duration of physical activity will be quantified by the mean time (in minutes) of activity bouts per day. Higher values will be taken as evidence of greater physical activity.
| mean time (in minutes) of activity bouts | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Duration of Physical Activity at 8 Weeks | 3.68 (2.84 to 4.53) |
To assess the duration of physical activity, transfemoral prosthesis users will wear a StepWatch4 activity monitor (Modus Health, Edmonds, WA) for a 2-week period. Activity bouts, or periods of time in which steps occur in successive 10-second intervals, will be derived from step count data. The duration of physical activity will be quantified by the mean time (in minutes) of activity bouts per day. Higher values will be taken as evidence of greater physical activity.
| mean time (in minutes) of activity bouts | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Duration of Physical Activity at 42 Weeks | 3.76 (2.71 to 4.81) |
Collected over Adverse event data were collected for 42 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Baseline Ischial Containment to Subischial Socket | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Mean | 45.6 ± 21.4 |
| Sex: Female, Male(Participants) | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Female | 2 |
| Male | 3 |
| Ethnicity (NIH/OMB)(Participants) | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 4 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Baseline Ischial Containment to Subischial Socket |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Baseline Ischial Containment to Subischial Socket |
|---|---|
| United States | 5 |
| Body mass(kg) | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Mean | 78.8 ± 6.81 |
| Height(meters) | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Mean | 1.73 ± 0.06 |
| Residual limb length(cm) | Baseline Ischial Containment to Subischial Socket |
|---|---|
| Mean | 26 ± 3.2 |
6 further baseline measures are reported on the registry.
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University of Illinois at Chicago