Strength, Pain and Function in Operation Iraqi Freedom/Operation Enduring Freedom Amputees: A Nurse-Managed Program
Condition: Traumatic Amputation
MeSH terms: Amputation, Traumatic
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): NMES (EMPI 300PV stimulator) plus standard of care; TMARP standard of care
Intervention type(s): Device; Behavioral
Intervention description(s): 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.; 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.
Other intervention name(s): EMPI 300PV neuromuscular stimulator; Traditional Military Amputee Rehabilitation Program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Case Management; Amputation; Muscle strength; phantom limb pain