Electromyostimulation and Strength Walking for Knee Injuries
Condition: Knee Injury
MeSH terms: Wounds and Injuries; Knee Injuries
Study type: Interventional

Summary: 
      The purpose of this project is to compare three treatment regimens for knee injury to the
      standard rehabilitation protocol: 1) NMES, 2) graduated strength walking (via a weighted
      vest), and 3) NMES combined with graduated strength walking. Each treatment arm will be
      supplemented by the standard of care and compared to a group who receive the standard
      rehabilitation only.

      The Study will compare the effects of NMES, Strength Walking and combined NMES/ Strength
      Walking on strength, mobility, symptomatology, and Quality of Life (QOL) in military members
      with knee injury to a standard rehabilitation protocol program only. All groups will
      participate in standard rehabilitation protocol. The groups will be assessed over 18 weeks to
      compare main and interactive effects over time.
    

Detailed description: 
      The prevalence of knee injuries has shown a striking increase of >24% over the last 5 years,
      affecting work performance, limiting mobility, and impacting military deployment health. This
      increase reflects the current high op-tempo and frequent deployments of a nation at war
      including activities related to military operations, physical fitness, and demanding
      training. We have shown that neuromuscular electrical stimulation (NMES) improves quadriceps
      muscle strength. We have also shown that a pedometer-based protocol improves fitness. The
      overall objective of this project is to compare three treatment regimens for knee injury to
      the standard rehabilitation protocol as potential treatments for improving strength, work
      efficiency, and mobility in active duty military personnel with a knee injury. Our central
      hypothesis is that the combination of NMES and walking while wearing a weighted vest will
      demonstrate greater improvements in muscle strength, work efficiency, and mobility, as
      compared to the usual care alone. The rationale is that NMES combined with graduated strength
      walking could produce marked improvements in muscle strength and thereby enhance work
      performance, readiness and fitness, decrease physical symptoms and faster return to duty.
      NMES and graduated strength walking, simulate the current uniform in the theatre of operation
      (body armor).The specific aims are to compare the effectiveness of three treatment regimens
      to the usual care in improving: (1) muscle strength, (2) work efficiency, (3) mobility, (4)
      symptoms/pain, and (5) quality of life. After baseline testing, we propose to randomly assign
      male and female subjects (n=132) ages 18 to 50 years with a knee injury to one of 4 groups:
      1) NMES, 2) strength walking, 3) NMES and strength walking, or 4) usual care. All groups will
      receive 12-weeks of the intervention and 6-weeks of follow-up. Generalized estimating
      equation (GEE) methods will be used to build regression models for statistical analysis of
      longitudinal data. If the interventions are effective with respect to parameters of strength,
      mobility, work performance, and symptoms, recommendations for future treatments can be made.
      This is hugely important, given the rising rate of knee injuries and the possibility that
      provider-managed care would be critical for assisting our warriors in a rapid recovery and
      return to duty.
    

Intervention name(s): NMES; Strength Walking; Standard Rehabilitation Protocol
Intervention type(s): Device; Behavioral; Behavioral
Intervention description(s): Participants will train at 15-20% of maximal voluntary contraction (MVC) during weeks 1-3, 21-30% of MVC during weeks 3-6 and 31-40% of MVC during weeks 6-9, 41-50% of MVC during weeks 9-12, then sustain 50% of MVC during weeks 12-18. Incremental increases will be made at the 3, 6, 9, and 12-week clinic visits.; Strength Walking participants will maintain a daily training log. Pedometer readings will form the basis for setting activity goals. Initial step goals will be 10% above the average 3-day pedometer step count taken at baseline, with a 10% increase every other week, and then a gradual increase when 30% above the baseline step count has been achieved. At week 7, participants will be given a weighted vest to begin the strengthening component. Participants will be instructed to wear the vest during their 30-minute walk, 3 to 4 days a week. The beginning weight load for the vest will be calculated using 2% of baseline body weight and it will be increased by that same amount every week thereafter until the end of the 12 weeks.; All participants will receive the current standard of care at the 2 military sites (Walter Reed National Military Medical Center (WRNMMC) and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC)) of the physical therapy rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at WRNMMC and MGMCSC physical therapy clinic.
Other intervention name(s): EMPI 300PV neuromuscular stimulator
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Muscle strength; Electrical muscle stimulation; Strength training