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Electromyostimulation and Strength Walking for Knee Injuries

NCT02065518 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2019-08-28

Study results available
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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.

Conditions

  • Knee Injury

Interventions

DEVICE

NMES

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.

BEHAVIORAL

Strength Walking

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.

BEHAVIORAL

Standard Rehabilitation Protocol

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.

Sponsors & Collaborators

  • Walter Reed National Military Medical Center

    collaborator FED

  • Malcolm Grow Medical Clinics and Surgery Center

    collaborator FED

  • University of Tennessee

    lead OTHER

Principal Investigators

  • Laura A Talbot, PhD, RN · University of Tennessee Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-08-31
Completion
2018-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02065518 on ClinicalTrials.gov