An interventional study of NMES (EMPI 300PV stimulator) plus standard of care and TMARP standard of care in Traumatic Amputation, sponsored by University of Tennessee. Completed at 3 sites in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-04-10.
Sponsored by University of Tennessee · Not applicable, Interventional, and Other
The purpose of this randomized control study is to determine if administering neuromuscular electrical stimulation (NMES) to the thigh muscles of a below the knee amputee is more effective than the current standard of care in preserving thigh muscle strength. In addition, this study will examine the NMES treatment effects on the participant's gait, quality of life, functional performance of standing, walking, and stair climbing, and symptoms associated with residual and phantom limb pain. The primary aim is to compare NMES plus standard rehabilitation (treatment group) to the standard rehabilitation (control group) by measuring lower extremity muscle strength. The secondary aims are to compare NMES treatment group to the control group by measuring Quality of Life (QOL) and the symptoms associated with residual \& phantom limb pain. In addition to the specific aims, this study will also examine the two groups for functional performance and gait patterns after prosthetic fitting.
Traumatic amputation is one of the major injuries seen as a result of Operation Iraqi and Enduring Freedom with the majority being single trans-tibial amputations (TTA). TTA experience significant reductions in thigh muscle strength of the amputated limb during the first year after amputation. The residual limb is less active in daily functions of standing and walking, resulting in progressive atrophy of the quadriceps muscles in terms of a decrease in thigh diameter which is estimated at 25% of pre-amputation diameter. An intervention that may be useful in TTA rehabilitation is neuromuscular electrical stimulation (NMES). The overall objectives of this study is to test two different approaches to prosthetic rehabilitation as potential treatments for improving muscle strength, pain and functional performance of daily activities in military personnel with TTA. Our central hypothesis is that a Nurse Managed NMES rehabilitation program will have greater improvements in muscle strength and pain as compared to the standard rehabilitation protocol alone. The rationale for this study is that NMES could have an additive effect to the Walter Reed Army Medical Center (WRAMC) standard of care program with greater improvements in muscle strength thus enhancing the performance of daily activities, Quality of Life (QOL), and decreasing disability. Such outcomes will ultimately result in decreased economic costs, accelerated rehabilitation, and potentially increase the possibility of these warriors returning to duty. The specific aims are to test Nurse Managed NMES relative to standard rehabilitation by comparing: (1) Lower extremity muscle strength; (2) QOL; and (3) Symptoms associated with phantom pain. In addition to the above aims, specific aims for the post prosthetic phase of the intervention are to compare the two groups for (4) functional performance of daily activities. After pre-testing, participants aged 18 to 55 yrs with a traumatic TTA will be randomly assigned to either the 1) Nurse Managed NMES rehabilitation program (n=30); or 2) WRAMC Amputee Protocol (n=30). Those in the NMES group will receive 12 weeks of electrical muscle stimulation 15 min/day, 5 days a week for 12 weeks. Both groups will receive the standard 12-week Walter Reed Army Medical Center rehabilitation protocol. Generalized Estimating Equation methods will be used to build regression models for statistical analysis of the longitudinal data. The significance of this research is that Nurse Managed NMES may be very important for accelerating the rehabilitation of amputees so they can achieve functional independence and regain lost muscle strength in preparation for return to duty.
102 studies on the registry are indexed under Amputation, Traumatic; 14 are open to participants now.
This study's enrollment of 44 is above the median of 13 across 69 interventional studies indexed under Amputation, Traumatic.
Browse Amputation, Traumatic studies →University of Tennessee is the lead sponsor of 142 studies on the registry; 21 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
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Exclusion Criteria:
NMES (EMPI 300PV stimulator) plus standard of care intervention. NMES is to the quadriceps muscle of the residual and intact limb plus rehabilitation. Therapy is 12-wks of NMES home training w/ the EMPI 300PV muscle stimulator. Participants perform training at home for 5days/wk; sessions consisted of 15 to 20 min. of NMES to each leg eliciting15 contractions/leg (10 seconds on:50 seconds off), plus a 5-minute patient treatment log, 5x/wk for 12-wks. Each contraction will be elicited by an electrical impulse generated by a battery-operated device. Two 3" X 5" electrodes are placed over the quadriceps muscle group. Participants will train at 30-40% of MVC during weeks 1-6, and 40-50% of MVC during weeks 7-12; incremental increases will be made at the study visits.
Device: NMES (EMPI 300PV stimulator) plus standard of care
TMARP standard of care intervention: 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1 week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks, preparing for the prosthetic. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
Behavioral: TMARP standard of care
In addition to the standard rehabilitation, the NMES treatment group will receive neuromuscular electrical stimulation to the quadriceps muscle of the residual and intact limb. The name of the NMES device is EMPI 300PV. NMES training will consist of performing 15 to 20 minute stimulation sessions with a 5-minute patient treatment log, 5 times per week for 12 weeks. During each training session, 15 NMES contractions per leg will be completed. Each contraction will be elicited by an electrical impulse (300PV) generated by a battery-operated device. This will be performed at home.
Also known as: EMPI 300PV neuromuscular stimulator
The usual care is 12 weeks of the Traditional Military Amputee Rehabilitation Program (TMARP). TMARP training starts 1week after surgical closure of the residual limb. Physical Therapy performs Pre-Prosthetic Training for about 6 weeks, preparing for the prosthetic. After pre-prosthetic training, patients are fitted with their prosthetic leg and began post-prosthetic training with PT. The training focus is lower limb prosthetic proficient in ambulation.
Also known as: Traditional Military Amputee Rehabilitation Program
Lower Extremity Muscle Strength- Extension
Muscle strength was measured with a handheld dynamometer for extensor knee strength of the residual and intact limb.
Time frame: 0, 3, 6, 9, 12 wks
Lower Extremity Muscle Strength- Flexion
Muscle strength was measured with a handheld dynamometer for extensor and flexor knee strength of the residual and intact limb.
Time frame: 0, 3, 6, 9, 12 wks
Lower Extremity Mobility-Distance
Mobility was measured by the distance walked in 2 minutes.
Time frame: 6, 12 wks
Lower Extremity Mobility- Up and Go
Mobility was measured by the time to complete an "up and go" test.
Time frame: 6, 12 wks
Lower Extremity Mobility- Stair Climb
Mobility was measured by the time to complete a timed stair climb.
Time frame: 6, 12 wks
Lower Extremity Mobility-Chair Rise
Mobility was measured by the number of stands during the 30-second chair rise test.
Time frame: 6, 12 wks
Pain Severity
Pain severity was measured using a 4-item subscale of the Brief Pain Inventory. Pain is assessed at its "worst," "least," "average," and "current" level. Scores range from 0 (no pain) to 10 (pain, as bad as one can imagine). A mean pain score was calculated from the four items.
Time frame: 0, 3, 6, 9, 12 wks
Pain Interference
Pain interference was measured as how pain hindered daily activities: general activities, walking, work, mood, enjoyment of life, relations with others, and sleep using the Brief Pain Inventory. Participants rate each item on a scale from 0-10 (0=does not interfere; 10=completely interferes). The interference score represents the mean of the seven items.
Time frame: 0, 3, 6, 9, 12 wks
| Milestone | Standard Rehabilitation Protocol | NMES Plus Standard Rehabilitation Protocol |
|---|---|---|
| Started | 21 | 23 |
| Completed | 21 | 23 |
| Not completed | 0 | 0 |
Muscle strength was measured with a handheld dynamometer for extensor knee strength of the residual and intact limb.
| Kilograms | Standard Rehabilitation Protocol | NMES Plus Standard Rehabilitation Protocol |
|---|---|---|
| Residual Limb: Week 0 | 24.5 ± 10.7 | 26.4 ± 13.4 |
| Residual Limb: Week 3 | 27.6 ± 12.5 | 34.1 ± 12.7 |
| Residual Limb: Week 6 | 33.8 ± 17.3 | 36.9 ± 12.6 |
| Residual Limb: Week 9 | 35.7 ± 14.0 | 39.1 ± 16.5 |
| Residual Limb: Week 12 | 36.1 ± 15.4 | 42.8 ± 14.8 |
| Intact Limb: Week 0 | 45.7 ± 23.8 | 45.4 ± 17.6 |
| Intact Limb: Week 3 | 45.2 ± 24.3 | 41.4 ± 16.1 |
| Intact Limb: Week 6 | 45.0 ± 19.5 | 45.2 ± 13.7 |
| Intact Limb: Week 9 | 46.0 ± 16.7 | 45.7 ± 16.1 |
| Intact Limb: Week 12 | 49.0 ± 20.7 | 51.8 ± 16.6 |
Muscle strength was measured with a handheld dynamometer for extensor and flexor knee strength of the residual and intact limb.
| Kilograms | Standard Rehabilitation Protocol | NMES Plus Standard Rehabilitation Protocol |
|---|---|---|
| Residual Limb: Week 0 | 14.8 ± 8.5 | 14.2 ± 6.2 |
| Residual Limb: Week 3 | 14.8 ± 7.4 | 16.7 ± 7.0 |
| Residual Limb: Week 6 | 16.8 ± 7.3 | 18.7 ± 6.9 |
| Residual Limb: Week 9 | 18.4 ± 7.5 | 19.9 ± 7.6 |
| Residual Limb: Week 12 | 19.5 ± 8.4 | 21.8 ± 6.6 |
| Intact Limb: Week 0 | 25.4 ± 7.1 | 27.8 ± 10.7 |
| Intact Limb: Week 3 | 27.1 ± 10.2 | 28.7 ± 9.4 |
| Intact Limb: Week 6 | 26.9 ± 10.9 | 32.2 ± 10.3 |
| Intact Limb: Week 9 | 28.8 ± 9.9 | 30.9 ± 9.7 |
| Intact Limb: Week 12 | 28.8 ± 10.1 | 29.4 ± 9.9 |
Mobility was measured by the distance walked in 2 minutes.
| inches | Standard Rehabilitation Protocol | NMES Plus Standard Rehabilitation Protocol |
|---|---|---|
| Usual Pace: Week 6 | 5081 ± 2324 | 4452 ± 1949 |
| Usual Pace: Week 12 | 5853 ± 2420 | 5657 ± 1919 |
| Fast Pace: Week 6 | 7308 ± 2557 | 6369 ± 2316 |
| Fast Pace: Week 12 | 8116 ± 2763 | 7692 ± 2072 |
Mobility was measured by the time to complete an "up and go" test.
| Seconds | Standard Rehabilitation Protocol | NMES Plus Standard Rehabilitation Protocol |
|---|---|---|
| Week 6 | 7.3 ± 3.9 | 7.7 ± 4.8 |
| Week 12 | 6.3 ± 3.5 | 7.1 ± 4.4 |
Mobility was measured by the time to complete a timed stair climb.
| Seconds | Standard Rehabilitation Protocol | NMES Plus Standard Rehabilitation Protocol |
|---|---|---|
| Week 6 | 7.8 ± 3.8 | 7.5 ± 4.4 |
| Week 12 | 4.7 ± 3.3 | 5.6 ± 4.0 |
Mobility was measured by the number of stands during the 30-second chair rise test.
| Number of stands | Standard Rehabilitation Protocol | NMES Plus Standard Rehabilitation Protocol |
|---|---|---|
| Week 6 | 18.1 ± 11.4 | 15.7 ± 8.4 |
| Week 12 | 21.7 ± 9.9 | 19.4 ± 9.2 |
Pain severity was measured using a 4-item subscale of the Brief Pain Inventory. Pain is assessed at its "worst," "least," "average," and "current" level. Scores range from 0 (no pain) to 10 (pain, as bad as one can imagine). A mean pain score was calculated from the four items.
| units on a scale | Standard Rehabilitation Protocol | NMES Plus Standard Rehabilitation Protocol |
|---|---|---|
| Week 0 | 2.9 ± 1.5 | 3.3 ± 1.6 |
| Week 3 | 2.6 ± 1.4 | 2.4 ± 1.6 |
| Week 6 | 2.2 ± 1.7 | 2.2 ± 1.4 |
| Week 9 | 2.2 ± 1.6 | 2.6 ± 1.7 |
| Week 12 | 1.8 ± 1.6 | 2.4 ± 1.9 |
Pain interference was measured as how pain hindered daily activities: general activities, walking, work, mood, enjoyment of life, relations with others, and sleep using the Brief Pain Inventory. Participants rate each item on a scale from 0-10 (0=does not interfere; 10=completely interferes). The interference score represents the mean of the seven items.
| units on a scale | Standard Rehabilitation Protocol | NMES Plus Standard Rehabilitation Protocol |
|---|---|---|
| Week 0 | 2.9 ± 2.4 | 3.1 ± 2.4 |
| Week 3 | 2.5 ± 2.2 | 2.2 ± 2.0 |
| Week 6 | 2.3 ± 2.6 | 2.4 ± 2.3 |
| Week 9 | 2.0 ± 2.5 | 2.8 ± 2.7 |
| Week 12 | 2.1 ± 2.5 | 2.7 ± 2.8 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Rehabilitation Protocol | — | 0/21 (0%) | 0/21 (0%) |
| NMES w/ Rehab | — | 0/23 (0%) | 0/23 (0%) |
| Age, Categorical(Participants) | Standard Rehabilitation Protocol | NMES Plus Standard Rehabilitation Protocol | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 21 | 23 | 44 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Standard Rehabilitation Protocol | NMES Plus Standard Rehabilitation Protocol | Total |
|---|---|---|---|
| Mean | 27.1 ± 6.3 | 26.5 ± 5.9 | 26.5 ± 5.9 |
| Sex: Female, Male(Participants) | Standard Rehabilitation Protocol | NMES Plus Standard Rehabilitation Protocol | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 21 | 22 | 43 |
| Region of Enrollment(participants) | Standard Rehabilitation Protocol | NMES Plus Standard Rehabilitation Protocol | Total |
|---|---|---|---|
| United States | 21 | 23 | 44 |
Plan to share: No
The record gives a start of Apr 2009, a primary completion of Aug 2015 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2018, 2 years 8 months after primary completion.
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