An interventional study of C-Brace in Hemiparesis Due to Stroke and Hemiplegia Due to Stroke, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-11-08.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
The purpose of this study is to develop a clinical algorithmic-based evaluation and treatment approach for C-Brace for use by persons with hemiparesis or hemiplegia due to stroke.
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Exclusion Criteria:
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
Device: C-Brace
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
During the 10 Meter Walk Test (10MWT), infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using the Northern Digital Inc (NDI) Optotrak Certus motion capture system. Marker data will be processed using custom Matlab program to determine lower extremity joint excursion. Joint excursion is the range of motion of a particular joint, and the range of motion is reported in degrees. After stroke, one side of the body is affected, and joint excursion for various joint angles (of hip, knee, and ankle) are reported for both sides of the body (affected side of body and unaffected side of body).
Time frame: week 5
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
During the 10 Meter Walk Test (10MWT), infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using the NDI Optotrak Certus motion capture system. Marker data will be processed using custom Matlab program to determine lower extremity joint excursion. Joint excursion is the range of motion of a particular joint, and the range of motion is reported in degrees. After stroke, one side of the body is affected, and joint excursion for various joint angles (of hip, knee, and ankle) are reported for both sides of the body (affected side of body and unaffected side of body).
Time frame: week 9
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Bipolar surface electrodes will be placed on the bilateral major leg muscles to record electromyography (1000Hz, Motion Labs 16-Channel EMG System). The EMG amplitude (in volts) will be calculated over the whole gait cycle during the 10 Meter Walk Test (10MWT), in which the participant walks 10 meters. After stroke, one side of the body is affected, and data for various muscles are reported for both sides of the body (affected side of body and unaffected side of body).
Time frame: week 5
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Bipolar surface electrodes will be placed on the bilateral major leg muscles to record electromyography (1000Hz, Motion Labs 16-Channel EMG System). The EMG amplitude (in volts) will be calculated over the whole gait cycle during the 10 Meter Walk Test (10MWT), in which the participant walks 10 meters. After stroke, one side of the body is affected, and data for various muscles are reported for both sides of the body (affected side of body and unaffected side of body).
Time frame: week 9
Metabolic Expenditure During Walking
Change in metabolic expenditure during walking will be indicated by energy expenditure. Energy Expenditure will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally.
Time frame: week 5
Metabolic Expenditure During Walking
Change in metabolic expenditure during walking will be indicated by energy expenditure. Energy Expenditure will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally.
Time frame: week 9
Score on the Timed Up and Go Test
Assesses mobility, balance, walking ability, and fall risk in older adults. The test measures the time it takes the subject to perform a sit to stand from a chair with arms, walk to a mark on the ground 10 feet away and return to the seated position in the chair with arms. This test has been used in assessing stroke recovery with high reliability and validity.
Time frame: week 0
Score on the Timed Up and Go Test
Assesses mobility, balance, walking ability, and fall risk in older adults. The test measures the time it takes the subject to perform a sit to stand from a chair with arms, walk to a mark on the ground 10 feet away and return to the seated position in the chair with arms. This test has been used in assessing stroke recovery with high reliability and validity.
Time frame: week 5
Score on the Timed Up and Go Test
Assesses mobility, balance, walking ability, and fall risk in older adults. The test measures the time it takes the subject to perform a sit to stand from a chair with arms, walk to a mark on the ground 10 feet away and return to the seated position in the chair with arms. This test has been used in assessing stroke recovery with high reliability and validity.
Time frame: week 9
Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE)
Mini Mental State Examination provides information about orientation, attention, learning, calculation, delayed recall, and construction. Several studies report acceptable validity of MMSE as a screening instrument and its relationship to functional outcome in stroke population. Total score ranges from 0 to 30, with a higher score indicating a better outcome.
Time frame: week 0
Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE)
Mini Mental State Examination provides information about orientation, attention, learning, calculation, delayed recall, and construction. Several studies report acceptable validity of MMSE as a screening instrument and its relationship to functional outcome in stroke population. Total score ranges from 0 to 30, with a higher score indicating a better outcome.
Time frame: week 9
Change in Hip Flexors Strength as Assessed by Dynamometry
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip flexors.
Time frame: week 0, week 9
Change in Hip Extensors Strength as Assessed by Dynamometry
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip extensors.
Time frame: week 0, week 9
Change in Hip Abductors Strength as Assessed by Dynamometry
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip abductors.
Time frame: week 0, week 9
Change in Hip Adductors Strength as Assessed by Dynamometry
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip adductors.
Time frame: week 0, week 9
Change in Knee Flexors Strength as Assessed by Dynamometry
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as knee flexors.
Time frame: week 0, week 9
Change in Knee Extensors Strength as Assessed by Dynamometry
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as knee extensors.
Time frame: week 0, week 9
Change in Ankle Dorsiflexors Strength as Assessed by Dynamometry
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as ankle dorsiflexors.
Time frame: week 0, week 9
Change in Ankle Plantarflexors. Strength as Assessed by Dynamometry
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as ankle plantarflexors.
Time frame: week 0, week 9
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Range of motion will be measured on bilateral hip using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected hip will be measured and also the range of motion of their other hip (the unaffected hip) will be measured \[it is possible that a participant will have a range of motion within normal limits on both hip sides (affected hip and unaffected hip)\].
Time frame: week 0
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Range of motion will be measured on bilateral hip using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected hip will be measured and also the range of motion of their other hip (the unaffected hip) will be measured \[it is possible that a participant will have a range of motion within normal limits on both hip sides (affected hip and unaffected hip)\].
Time frame: week 9
Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Range of motion will be measured on knee joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected knee will be measured and also the range of motion of their other knee (the unaffected knee) will be measured \[it is possible that a participant will have a range of motion within normal limits for both knees (affected knee and unaffected knee)\].
Time frame: week 0
Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Range of motion will be measured on knee joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected knee will be measured and also the range of motion of their other knee (the unaffected knee) will be measured \[it is possible that a participant will have a range of motion within normal limits for both knees (affected knee and unaffected knee)\].
Time frame: week 9
Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Range of motion will be measured on ankle joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected ankle will be measured and also the range of motion of their other ankle (the unaffected ankle) will be measured \[it is possible that a participant will have a range of motion within normal limits for both ankles (affected ankle and unaffected ankle)\].
Time frame: week 0
Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Range of motion will be measured on ankle joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected ankle will be measured and also the range of motion of their other ankle (the unaffected ankle) will be measured \[it is possible that a participant will have a range of motion within normal limits for both ankles (affected ankle and unaffected ankle)\].
Time frame: week 9
Motor Impairment as Determined by the Fugl-Meyer Assessment
The Fugl-Meyer Assessment evaluates and measures recovery of movement in individual post stroke. The Fugl-Meyer has been used in both clinical and research settings and is one of the most widely used quantitative measures of motor impairment. It uses an ordinal scale for scoring of 17 items for the lower limb component and 7 items on the balance component, for a total of 24 items. Each of the 24 items is scored as 0 (cannot perform), 1 (can perform partially), or 2 (can perform fully), with a total score ranging from 0 to 48, with a higher score indicating less impairment.
Time frame: week 0
Motor Impairment as Determined by the Fugl-Meyer Assessment
The Fugl-Meyer Assessment evaluates and measures recovery of movement in individual post stroke. The Fugl-Meyer has been used in both clinical and research settings and is one of the most widely used quantitative measures of motor impairment. It uses an ordinal scale for scoring of 17 items for the lower limb component and 7 items on the balance component, for a total of 24 items. Each of the 24 items is scored as 0 (cannot perform), 1 (can perform partially), or 2 (can perform fully), with a total score ranging from 0 to 48, with a higher score indicating less impairment.
Time frame: week 9
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in lower limbs.
Time frame: week 0
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in lower limbs.
Time frame: week 9
Static Balance as Assessed by the Berg Balance Scale (BBS)
A 14-item objective measure designed to assess static balance and fall risk in adult populations, with a total score range of 0 to 56 (higher scores represent better functional outcome). This test has been widely used to measure functional recovery in stroke patients with high reliability.
Time frame: week 0
Static Balance as Assessed by the Berg Balance Scale (BBS)
A 14-item objective measure designed to assess static balance and fall risk in adult populations, with a total score range of 0 to 56 (higher scores represent better functional outcome). This test has been widely used to measure functional recovery in stroke patients with high reliability.
Time frame: week 9
Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)
Measure of gait speed. Subjects will walk a total of 14 meters at their preferred walking speed and at a fast pace. The test measures the time it takes the subject to complete the middle 10 meters of the walk.
Time frame: week 0
Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)
Measure of gait speed. Subjects will walk a total of 14 meters at their preferred walking speed and at a fast pace. The test measures the time it takes the subject to complete the middle 10 meters of the walk.
Time frame: week 5
Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)
Measure of gait speed. Subjects will walk a total of 14 meters at their preferred walking speed and at a fast pace. The test measures the time it takes the subject to complete the middle 10 meters of the walk.
Time frame: week 9
Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)
The participant will perform the 6MWT, in which the participant will walk as far as possible in six minutes. During the 6MWT, the peak volume of oxygen consumed per minute (peak VO₂) will be measured by a portable metabolic system. Data are reported as peak volume of oxygen (in milliliters) consumed per kilogram bodyweight per minute per meter walked \[milliliters/kilogram/minute/meter (mL/kg/min/m)\].
Time frame: week 0
Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)
The participant will perform the 6MWT, in which the participant will walk as far as possible in six minutes. During the 6MWT, the peak volume of oxygen consumed per minute (peak VO₂) will be will be measured by a portable metabolic system. Data are reported as peak volume of oxygen (in milliliters) consumed per kilogram bodyweight per minute per meter walked \[milliliters/kilogram/minute/meter (mL/kg/min/m)\].
Time frame: week 5
Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)
The participant will perform the 6MWT, in which the participant will walk as far as possible in six minutes. During the 6MWT, the peak volume of oxygen consumed per minute (peak VO₂) will be will be measured by a portable metabolic system. Data are reported as peak volume of oxygen (in milliliters) consumed per kilogram bodyweight per minute per meter walked \[milliliters/kilogram/minute/meter (mL/kg/min/m)\].
Time frame: week 9
| Milestone | With C-brace |
|---|---|
| Started | 17 |
| Received intervention | 15 |
| Completed | 14 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 3 |
During the 10 Meter Walk Test (10MWT), infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using the Northern Digital Inc (NDI) Optotrak Certus motion capture system. Marker data will be processed using custom Matlab program to determine lower extremity joint excursion. Joint excursion is the range of motion of a particular joint, and the range of motion is reported in degrees. After stroke, one side of the body is affected, and joint excursion for various joint angles (of hip, knee, and ankle) are reported for both sides of the body (affected side of body and unaffected side of body).
| degrees | With C-brace |
|---|---|
| Affected Hip flexion-extension | 33.98 ± 10.03 |
| Affected Hip abduction-adduction | 9.34 ± 3.04 |
| Affected Hip internal-external rotation | 21.25 ± 14.45 |
| Affected Knee flexion-extension | 34.51 ± 16.55 |
| Affected Knee abduction-adduction | 7.72 ± 1.77 |
| Affected Knee internal-external rotation | 16.26 ± 9.53 |
| Affected Ankle flexion-extension | 13.51 ± 7.73 |
| Affected Ankle abduction-adduction | 6.06 ± 4.33 |
| Affected Ankle internal-external rotation | 8.36 ± 7.09 |
| Unaffected Hip flexion-extension | 45.31 ± 10.21 |
| Unaffected Hip abduction-adduction | 8.74 ± 3.11 |
| Unaffected Hip internal-external rotation | 14.82 ± 6.41 |
| Unaffected Knee flexion-extension | 53.71 ± 7.64 |
| Unaffected Knee abduction-adduction | 10.30 ± 4.79 |
| Unaffected Knee internal-external rotation | 11.83 ± 3.11 |
| Unaffected Ankle flexion-extension | 21.83 ± 6.36 |
| Unaffected Ankle abduction-adduction | 6.85 ± 1.75 |
| Unaffected Ankle internal-external rotation | 12.64 ± 4.20 |
During the 10 Meter Walk Test (10MWT), infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using the NDI Optotrak Certus motion capture system. Marker data will be processed using custom Matlab program to determine lower extremity joint excursion. Joint excursion is the range of motion of a particular joint, and the range of motion is reported in degrees. After stroke, one side of the body is affected, and joint excursion for various joint angles (of hip, knee, and ankle) are reported for both sides of the body (affected side of body and unaffected side of body).
| degrees | With C-brace |
|---|---|
| Affected Hip flexion-extension | 38.80 ± 11.26 |
| Affected Hip abduction-adduction | 9.03 ± 3.55 |
| Affected Hip internal-external rotation | 22.75 ± 15.71 |
| Affected Knee flexion-extension | 34.93 ± 17.02 |
| Affected Knee abduction-adduction | 7.92 ± 2.93 |
| Affected Knee internal-external rotation | 16.18 ± 7.71 |
| Affected Ankle flexion-extension | 15.91 ± 6.82 |
| Affected Ankle abduction-adduction | 6.82 ± 5.51 |
| Affected Ankle internal-external rotation | 7.55 ± 6.01 |
| Unaffected Hip flexion-extension | 46.20 ± 10.79 |
| Unaffected Hip abduction-adduction | 9.86 ± 3.34 |
| Unaffected Hip internal-external rotation | 14.99 ± 5.25 |
| Unaffected Knee flexion-extension | 55.55 ± 7.64 |
| Unaffected Knee abduction-adduction | 12.06 ± 5.83 |
| Unaffected Knee internal-external rotation | 12.78 ± 4.32 |
| Unaffected Ankle flexion-extension | 21.88 ± 4.78 |
| Unaffected Ankle abduction-adduction | 7.85 ± 2.17 |
| Unaffected Ankle internal-external rotation | 13.16 ± 5.42 |
Bipolar surface electrodes will be placed on the bilateral major leg muscles to record electromyography (1000Hz, Motion Labs 16-Channel EMG System). The EMG amplitude (in volts) will be calculated over the whole gait cycle during the 10 Meter Walk Test (10MWT), in which the participant walks 10 meters. After stroke, one side of the body is affected, and data for various muscles are reported for both sides of the body (affected side of body and unaffected side of body).
| volts | With C-brace |
|---|---|
| Affected Tibialis anterior | 0.2627 ± 0.0914 |
| Affected Soleus | 0.2484 ± 0.0641 |
| Affected Medial gastrocnemius | 0.2183 ± 0.1011 |
| Affected Vastus medialis | 0.2211 ± 0.0837 |
| Affected Rectus femoris | 0.2513 ± 0.0607 |
| Affected Biceps femoris | 0.3136 ± 0.0723 |
| Affected Semimembranous | 0.2184 ± 0.0734 |
| Unaffected Tibialis anterior | 0.2791 ± 0.0595 |
| Unaffected Soleus | 0.3095 ± 0.0574 |
| Unaffected Medial gastrocnemius | 0.2322 ± 0.0898 |
| Unaffected Vastus medialis | 0.2508 ± 0.0827 |
| Unaffected Rectus femoris | 0.2827 ± 0.0873 |
| Unaffected Biceps femoris | 0.2654 ± 0.0912 |
| Unaffected Semimembranous | 0.2835 ± 0.0895 |
Bipolar surface electrodes will be placed on the bilateral major leg muscles to record electromyography (1000Hz, Motion Labs 16-Channel EMG System). The EMG amplitude (in volts) will be calculated over the whole gait cycle during the 10 Meter Walk Test (10MWT), in which the participant walks 10 meters. After stroke, one side of the body is affected, and data for various muscles are reported for both sides of the body (affected side of body and unaffected side of body).
| volts | With C-brace |
|---|---|
| Affected Tibialis anterior | 0.2639 ± 0.0897 |
| Affected Soleus | 0.2776 ± 0.0755 |
| Affected Medial gastrocnemius | 0.3312 ± 0.0950 |
| Affected Vastus medialis | 0.2149 ± 0.1062 |
| Affected Rectus femoris | 0.2146 ± 0.1072 |
| Affected Biceps femoris | 0.2795 ± 0.0905 |
| Affected Semimembranous | 0.2781 ± 0.1045 |
| Unaffected Tibialis anterior | 0.3152 ± 0.0689 |
| Unaffected Soleus | 0.3057 ± 0.0649 |
| Unaffected Medial gastrocnemius | 0.2598 ± 0.0767 |
| Unaffected Vastus medialis | 0.2770 ± 0.0812 |
| Unaffected Rectus femoris | 0.2754 ± 0.0880 |
| Unaffected Biceps femoris | 0.3026 ± 0.1161 |
| Unaffected Semimembranous | 0.2877 ± 0.1002 |
Change in metabolic expenditure during walking will be indicated by energy expenditure. Energy Expenditure will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally.
| millilters/kilogram/minute (mL/kg/min) | With C-brace |
|---|---|
| Metabolic Expenditure During Walking | 0.03 ± 0.02 |
Change in metabolic expenditure during walking will be indicated by energy expenditure. Energy Expenditure will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally.
| millilters/kilogram/minute (mL/kg/min | With C-brace |
|---|---|
| Metabolic Expenditure During Walking | 0.03 ± 0.01 |
Assesses mobility, balance, walking ability, and fall risk in older adults. The test measures the time it takes the subject to perform a sit to stand from a chair with arms, walk to a mark on the ground 10 feet away and return to the seated position in the chair with arms. This test has been used in assessing stroke recovery with high reliability and validity.
| seconds | With C-brace |
|---|---|
| Score on the Timed Up and Go Test | 20.09 ± 12.38 |
Assesses mobility, balance, walking ability, and fall risk in older adults. The test measures the time it takes the subject to perform a sit to stand from a chair with arms, walk to a mark on the ground 10 feet away and return to the seated position in the chair with arms. This test has been used in assessing stroke recovery with high reliability and validity.
| seconds | With C-brace |
|---|---|
| Score on the Timed Up and Go Test | 19.37 ± 9.13 |
Assesses mobility, balance, walking ability, and fall risk in older adults. The test measures the time it takes the subject to perform a sit to stand from a chair with arms, walk to a mark on the ground 10 feet away and return to the seated position in the chair with arms. This test has been used in assessing stroke recovery with high reliability and validity.
| seconds | With C-brace |
|---|---|
| Score on the Timed Up and Go Test | 19.09 ± 9.75 |
Mini Mental State Examination provides information about orientation, attention, learning, calculation, delayed recall, and construction. Several studies report acceptable validity of MMSE as a screening instrument and its relationship to functional outcome in stroke population. Total score ranges from 0 to 30, with a higher score indicating a better outcome.
| score on a scale | With C-brace |
|---|---|
| Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE) | 28.50 ± 2.14 |
Mini Mental State Examination provides information about orientation, attention, learning, calculation, delayed recall, and construction. Several studies report acceptable validity of MMSE as a screening instrument and its relationship to functional outcome in stroke population. Total score ranges from 0 to 30, with a higher score indicating a better outcome.
| score on a scale | With C-brace |
|---|---|
| Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE) | 28.43 ± 2.65 |
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip flexors.
No measurements were reported for this outcome.
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip extensors.
No measurements were reported for this outcome.
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip abductors.
No measurements were reported for this outcome.
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip adductors.
No measurements were reported for this outcome.
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as knee flexors.
No measurements were reported for this outcome.
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as knee extensors.
No measurements were reported for this outcome.
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as ankle dorsiflexors.
No measurements were reported for this outcome.
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as ankle plantarflexors.
No measurements were reported for this outcome.
Range of motion will be measured on bilateral hip using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected hip will be measured and also the range of motion of their other hip (the unaffected hip) will be measured \[it is possible that a participant will have a range of motion within normal limits on both hip sides (affected hip and unaffected hip)\].
| Participants | With C-brace |
|---|---|
| Affected side hip flexion | 12 |
| Affected side hip extension | 11 |
| Affected side hip internal rotation | 13 |
| Affected side hip external rotation | 13 |
| Affected side hip abduction | 12 |
| Affected side hip adduction | 14 |
| Unaffected side hip flexion | 13 |
| Unaffected side hip extension | 13 |
| Unaffected side hip internal rotation | 13 |
| Unaffected side hip external rotation | 13 |
| Unaffected side hip abduction | 14 |
| Unaffected side hip adduction | 14 |
Range of motion will be measured on bilateral hip using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected hip will be measured and also the range of motion of their other hip (the unaffected hip) will be measured \[it is possible that a participant will have a range of motion within normal limits on both hip sides (affected hip and unaffected hip)\].
| Participants | With C-brace |
|---|---|
| Affected side hip flexion | 13 |
| Affected side hip extension | 11 |
| Affected side hip internal rotation | 12 |
| Affected side hip external rotation | 11 |
| Affected side hip abduction | 13 |
| Affected side hip adduction | 14 |
| Unaffected side hip flexion | 14 |
| Unaffected side hip extension | 13 |
| Unaffected side hip internal rotation | 14 |
| Unaffected side hip external rotation | 14 |
| Unaffected side hip abduction | 14 |
| Unaffected side hip adduction | 14 |
Range of motion will be measured on knee joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected knee will be measured and also the range of motion of their other knee (the unaffected knee) will be measured \[it is possible that a participant will have a range of motion within normal limits for both knees (affected knee and unaffected knee)\].
| Participants | With C-brace |
|---|---|
| Affected side knee flexion | 11 |
| Affected side knee extension | 12 |
| Unaffected side knee flexion | 13 |
| Unaffected side knee extension | 12 |
Range of motion will be measured on knee joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected knee will be measured and also the range of motion of their other knee (the unaffected knee) will be measured \[it is possible that a participant will have a range of motion within normal limits for both knees (affected knee and unaffected knee)\].
| Participants | With C-brace |
|---|---|
| Affected side knee flexion | 12 |
| Affected side knee extension | 14 |
| Unaffected side knee flexion | 14 |
| Unaffected side knee extension | 14 |
Range of motion will be measured on ankle joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected ankle will be measured and also the range of motion of their other ankle (the unaffected ankle) will be measured \[it is possible that a participant will have a range of motion within normal limits for both ankles (affected ankle and unaffected ankle)\].
| Participants | With C-brace |
|---|---|
| Affected side ankle dorsiflexion | 4 |
| Affected side ankle plantarflexion | 13 |
| Unaffected side ankle dorsiflexion | 13 |
| Unaffected side ankle plantarflexion | 14 |
Range of motion will be measured on ankle joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected ankle will be measured and also the range of motion of their other ankle (the unaffected ankle) will be measured \[it is possible that a participant will have a range of motion within normal limits for both ankles (affected ankle and unaffected ankle)\].
| Participants | With C-brace |
|---|---|
| Affected side ankle dorsiflexion | 6 |
| Affected side ankle plantarflexion | 12 |
| Unaffected side ankle dorsiflexion | 14 |
| Unaffected side ankle plantarflexion | 14 |
The Fugl-Meyer Assessment evaluates and measures recovery of movement in individual post stroke. The Fugl-Meyer has been used in both clinical and research settings and is one of the most widely used quantitative measures of motor impairment. It uses an ordinal scale for scoring of 17 items for the lower limb component and 7 items on the balance component, for a total of 24 items. Each of the 24 items is scored as 0 (cannot perform), 1 (can perform partially), or 2 (can perform fully), with a total score ranging from 0 to 48, with a higher score indicating less impairment.
| score on a scale | With C-brace |
|---|---|
| Motor Impairment as Determined by the Fugl-Meyer Assessment | 23.43 ± 4.52 |
The Fugl-Meyer Assessment evaluates and measures recovery of movement in individual post stroke. The Fugl-Meyer has been used in both clinical and research settings and is one of the most widely used quantitative measures of motor impairment. It uses an ordinal scale for scoring of 17 items for the lower limb component and 7 items on the balance component, for a total of 24 items. Each of the 24 items is scored as 0 (cannot perform), 1 (can perform partially), or 2 (can perform fully), with a total score ranging from 0 to 48, with a higher score indicating less impairment.
| score on a scale | With C-brace |
|---|---|
| Motor Impairment as Determined by the Fugl-Meyer Assessment | 24.29 ± 5.27 |
This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in lower limbs.
| score on a scale | With C-brace |
|---|---|
| Affected side hip flexor | 0 ± 0 |
| Affected side hip extensor | 0.07 ± 0.27 |
| Affected side knee flexors | 0.07 ± 0.27 |
| Affected side knee extensors | 0.5 ± 0.76 |
| Affected side ankle dorsiflexors | 0.21 ± 0.8 |
| Affected side ankle plantarflexors | 0.71 ± 0.97 |
| Unaffected side hip flexor | 0 ± 0 |
| Unaffected side hip extensor | 0 ± 0 |
| Unaffected side knee flexors | 0 ± 0 |
| Unaffected side knee extensors | 0 ± 0 |
| Unaffected side ankle dorsiflexors | 0 ± 0 |
| Unaffected side ankle plantarflexors | 0 ± 0 |
This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in lower limbs.
| score on a scale | With C-brace |
|---|---|
| Affected side hip flexor | 0.18 ± 0.46 |
| Affected side hip extensor | 0.07 ± 0.27 |
| Affected side knee flexors | 0.32 ± 0.54 |
| Affected side knee extensors | 0.64 ± 0.72 |
| Affected side ankle dorsiflexors | 0 ± 0 |
| Affected side ankle plantarflexors | 0.57 ± 0.73 |
| Unaffected side hip flexor | 0 ± 0 |
| Unaffected side hip extensor | 0 ± 0 |
| Unaffected side knee flexors | 0 ± 0 |
| Unaffected side knee extensors | 0 ± 0 |
| Unaffected side ankle dorsiflexors | 0 ± 0 |
| Unaffected side ankle plantarflexors | 0 ± 0 |
A 14-item objective measure designed to assess static balance and fall risk in adult populations, with a total score range of 0 to 56 (higher scores represent better functional outcome). This test has been widely used to measure functional recovery in stroke patients with high reliability.
| score on a scale | With C-brace |
|---|---|
| Static Balance as Assessed by the Berg Balance Scale (BBS) | 48.64 ± 5.17 |
A 14-item objective measure designed to assess static balance and fall risk in adult populations, with a total score range of 0 to 56 (higher scores represent better functional outcome). This test has been widely used to measure functional recovery in stroke patients with high reliability.
| score on a scale | With C-brace |
|---|---|
| Static Balance as Assessed by the Berg Balance Scale (BBS) | 49.79 ± 4.51 |
Measure of gait speed. Subjects will walk a total of 14 meters at their preferred walking speed and at a fast pace. The test measures the time it takes the subject to complete the middle 10 meters of the walk.
| meters per second | With C-brace |
|---|---|
| Gait Speed as Assessed by the 10 Meter Walk Test (10MWT) | 0.65 ± 0.28 |
Measure of gait speed. Subjects will walk a total of 14 meters at their preferred walking speed and at a fast pace. The test measures the time it takes the subject to complete the middle 10 meters of the walk.
| meters per second | With C-brace |
|---|---|
| Gait Speed as Assessed by the 10 Meter Walk Test (10MWT) | 0.66 ± 0.31 |
Measure of gait speed. Subjects will walk a total of 14 meters at their preferred walking speed and at a fast pace. The test measures the time it takes the subject to complete the middle 10 meters of the walk.
| meters per second | With C-brace |
|---|---|
| Gait Speed as Assessed by the 10 Meter Walk Test (10MWT) | 0.73 ± 0.29 |
The participant will perform the 6MWT, in which the participant will walk as far as possible in six minutes. During the 6MWT, the peak volume of oxygen consumed per minute (peak VO₂) will be measured by a portable metabolic system. Data are reported as peak volume of oxygen (in milliliters) consumed per kilogram bodyweight per minute per meter walked \[milliliters/kilogram/minute/meter (mL/kg/min/m)\].
| mL/kg/min/m | With C-brace |
|---|---|
| Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT) | 0.033 ± 0.015 |
The participant will perform the 6MWT, in which the participant will walk as far as possible in six minutes. During the 6MWT, the peak volume of oxygen consumed per minute (peak VO₂) will be will be measured by a portable metabolic system. Data are reported as peak volume of oxygen (in milliliters) consumed per kilogram bodyweight per minute per meter walked \[milliliters/kilogram/minute/meter (mL/kg/min/m)\].
| mL/kg/min/m | With C-brace |
|---|---|
| Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT) | 0.030 ± 0.015 |
The participant will perform the 6MWT, in which the participant will walk as far as possible in six minutes. During the 6MWT, the peak volume of oxygen consumed per minute (peak VO₂) will be will be measured by a portable metabolic system. Data are reported as peak volume of oxygen (in milliliters) consumed per kilogram bodyweight per minute per meter walked \[milliliters/kilogram/minute/meter (mL/kg/min/m)\].
| mL/kg/min/m | With C-brace |
|---|---|
| Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT) | 0.030 ± 0.013 |
Collected over 23 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| With C-brace | 0/15 (0%) | 1/15 (6.7%) | 8/15 (53.3%) |
| Event | With C-brace |
|---|---|
| SeizureNervous system disorders | 1/15 |
| Event | With C-brace |
|---|---|
| Fall at home/officeGeneral disorders | 4/15 |
| Skin pinchSkin and subcutaneous tissue disorders | 3/15 |
| BlisterSkin and subcutaneous tissue disorders | 1/15 |
| Skin rednessSkin and subcutaneous tissue disorders | 1/15 |
| High blood pressureGeneral disorders | 1/15 |
| Device non-functionInvestigations | 1/15 |
Baseline characteristics are reported for the 15 participants who received the intervention.
| Age, Categorical(Participants) | With C-brace |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 3 |
| Age, Continuous(years) | With C-brace |
|---|---|
| Mean | 58.5 ± 8.5 |
| Sex: Female, Male(Participants) | With C-brace |
|---|---|
| Female | 5 |
| Male | 10 |
| Race (NIH/OMB)(Participants) | With C-brace |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | With C-brace |
|---|---|
| United States | 15 |
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The University of Texas Health Science Center, Houston