Strength, Pain and Function in Operation Iraqi Freedom/Operation Enduring Freedom Amputees: A Nurse-Managed Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Strength, Pain and Function in Operation Iraqi Freedom/Operation Enduring Freedom Amputees: A Nurse-Managed Program

Conditions
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Traumatic Amputation

Intervention / Treatment
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* Device: NMES (EMPI 300PV stimulator) plus standard of care
* Behavioral: TMARP standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral trans-tibial amputee; Military service member at the time of injury (Active Duty, Reserves or National Guard); Age ≥18 and ≤55 years; and Able to provide freely given informed consent. Exclusion Criteria: A significant co-morbid medical condition (such as severe uncontrolled hypertension (over 160/100 mmHg) or neurological disorders such as epilepsy) where NMES strength training is contraindicated and/or participation would pose a safety threat or impair their ability to participate; Unable to speak and read English; Implanted cardiac pacemaker or defibrillator; Vision impairment where participant is classified as legally blind (we define legally blind both clinically and functionally. Clinically, it is central visual acuity of 20/200 or less in the better eye with corrective glasses. Functionally, the participant is not able to see the digital numbers on the NMES device with corrective glasses); Unwillingness to accept random assignment; Currently participating in another research study with an intervention that would potentially confound the outcome variables of this study (we will also instruct participants that joining a study after being enrolled in this protocol is also not allowed); and Conflicting co-morbidities including traumatic brain injury (score < 14 on glasgow coma scale), and a contralateral lower extremity injury that causes antalgic gait, pain > 5/10 consistently on the contralateral limb and/or a grade of < 4+/5 in lower extremity.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NMES plus Standard Rehab Protocol<br>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<br>* 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.<br>* Other names: EMPI 300PV neuromuscular stimulator;|
| Active Comparator: Standard Rehab Protocol<br>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<br>* 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.<br>* Other names: Traditional Military Amputee Rehabilitation Program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower Extremity Muscle Strength- Extension | Muscle strength was measured with a handheld dynamometer for extensor knee strength of the residual and intact limb. | 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. | 0, 3, 6, 9, 12 wks | 
| Lower Extremity Mobility-Distance | Mobility was measured by the distance walked in 2 minutes. | 6, 12 wks | 
| Lower Extremity Mobility- Up and Go | Mobility was measured by the time to complete an up and go test. | 6, 12 wks | 
| Lower Extremity Mobility- Stair Climb | Mobility was measured by the time to complete a timed stair climb. | 6, 12 wks | 
| Lower Extremity Mobility-Chair Rise | Mobility was measured by the number of stands during the 30-second chair rise test. | 6, 12 wks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 0, 3, 6, 9, 12 wks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Case Management, Amputation, Muscle strength, phantom limb pain