Clinical Trial: Electromyostimulation and Strength Walking for Knee Injuries

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Electromyostimulation and Strength Walking for Knee Injuries

Brief 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 Summary: 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
Sponsor: University of Tennessee

Current Primary Outcome:

• Change in lower extremity muscle strength across 6 time periods [ Time Frame: 0, 3, 6, 9, 12, and 18 weeks ]
  We are examining the outcome measure to determine if 1) the 4 treatment groups differ significantly in lower extremity muscle strength over time; 2) lower extremity muscle strength differs significantly across the 6 time periods; 3) is there an interaction between treatment and time in relation to lower extremity muscle strength.
• Change in work efficiency across 4 time periods [ Time Frame: 0, 6,12, and 18 weeks ]
  We are examining the outcome measure to determine if 1) the 4 treatment groups differ significantly in work efficiency over time; 2) work efficiency differs significantly across the 4 time periods; 3) is there an interaction between treatment and time in relation to work efficiency.
• Change in mobility across 4 time periods [ Time Frame: 0, 6, 12, and 18 weeks ]
  We are examining the outcome measure to determine if 1) the 4 treatment groups differ significantly in mobility over time; 2) mobility differs significantly across the 4 time periods; 3) is there an interaction between treatment and time in relation to mobility.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in symptoms/pain across 6 time periods [ Time Frame: 0, 3, 6, 9, 12, and 18 weeks ]
  We are examining the outcome measure to determine if 1) the 4 treatment groups differ significantly in symptoms/pain over time; 2)symptoms/pain differs significantly across the 6 time periods; 3) is there an interaction between treatment and time in relation to symptoms/pain.
• Change in quality of life (QOL) across 4 time periods [ Time Frame: 0, 6, 12, and 18 weeks ]
  We are examining the outcome measure to determine if 1) the 4 treatment groups differ significantly in quality of life (QOL) over time; 2)quality of life (QOL) differs significantly across the 4 time periods; 3) is there an interaction between treatment and time in relation to quality of life (QOL).

Original Secondary Outcome: Same as current

Information By: University of Tennessee

Dates:
Date Received: February 12, 2014
Date Started: March 2014
Date Completion: August 2017
Last Updated: October 18, 2016
Last Verified: July 2016