Electromyostimulation and Strength Walking for Knee Injuries (KI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Tennessee
Sponsor:
Collaborator:
Walter Reed National Military Medical Center
Information provided by (Responsible Party):
University of Tennessee
ClinicalTrials.gov Identifier:
NCT02065518
First received: February 12, 2014
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

The purpose of this project is to compare three treatment regimens for knee injury to the standard WRNMMC 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 WRNMMC standard of care and compared to a group who receive the standard WRNMMC 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 WRNMMC standard rehabilitation protocol. The groups will be assessed over 18 weeks to compare main and interactive effects over time.


Condition Intervention
Knee Injury
Device: NMES
Behavioral: Strength Walking
Behavioral: Standard Rehabilitation Protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Electromyostimulation and Strength Walking for Knee Injuries

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Change in lower extremity muscle strength across 6 time periods [ Time Frame: 0, 3, 6, 9, 12, and 18 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in symptoms/pain across 6 time periods [ Time Frame: 0, 3, 6, 9, 12, and 18 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 132
Study Start Date: March 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Rehabilitation Protocol (SRP)
All participants will receive the current standard of care, the Walter Reed National Military Medical Center (WRNMMC) rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at the WRNMMC physical therapy clinic.
Behavioral: Standard Rehabilitation Protocol
All participants will receive the current standard of care, the Walter Reed National Military Medical Center (WRNMMC) rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at the WRNMMC physical therapy clinic.
Experimental: NMES w/ SRP
In addition to the standard WRNMMC rehabilitation protocol, two treatment groups will receive a portable lightweight device (300PV unit) that provides clearly defined electrical stimuli. NMES training will consist of performing four 30-minute stimulation sessions per week for 12 weeks; each 30-minute session will entail 15 minutes/leg with 15 contractions per leg. Each contraction will be elicited by an electrical impulse (300PV) generated by a battery-operated device (EMPI, St. Paul, MN).
Device: NMES
Participants will train at 15-20% of maximal voluntary contraction (MVC) during weeks 1-3, 20-30% of MVC during weeks 3-6 and 30-40% of MVC during weeks 6-9, 40-50% 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.
Other Name: EMPI 300PV neuromuscular stimulator
Behavioral: Standard Rehabilitation Protocol
All participants will receive the current standard of care, the Walter Reed National Military Medical Center (WRNMMC) rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at the WRNMMC physical therapy clinic.
Experimental: Strength Walking w/ SRP
The Strength Walking groups will participate in a Home-Based Pedometer-Driven Walking Program. All participants in this group will be given a pedometer to monitor their daily steps and, at week 7, a weighted exercise vest to begin the strengthening component. In addition to the standard WRNMMC rehabilitation protocol, a series of 10-minute lessons focused on increasing physical activity through lifestyle education and the use of a pedometer as a motivational tool and personal fitness tracker will be incorporated into their testing sessions for the first 6 weeks. At week 7, participants will be given a vest to begin the strengthening component.
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 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, the Walter Reed National Military Medical Center (WRNMMC) rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at the WRNMMC physical therapy clinic.
Experimental: NMES/Strength Walking w/ SRP
In addition to the standard WRNMMC rehabilitation protocol, one group will receive NMES training and will participate in a Home-Based Pedometer-Driven Walking Program. This group will follow the protocol for both the NMES training and Strength Walking.
Device: NMES
Participants will train at 15-20% of maximal voluntary contraction (MVC) during weeks 1-3, 20-30% of MVC during weeks 3-6 and 30-40% of MVC during weeks 6-9, 40-50% 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.
Other Name: EMPI 300PV neuromuscular stimulator
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 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, the Walter Reed National Military Medical Center (WRNMMC) rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at the WRNMMC physical therapy clinic.

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 WRNMMC 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of knee injury (internal derangement of the knee with new effusion, including knee sprain or strains, meniscal tear, cruciate ligamentous tear, and chondral flap or injury);
  • A diagnosis of knee pain that is anterior knee pain, overuse pain, patella-femoral pain, and chronic pain (less than 6 months) associated with overuse syndromes which negatively impacts performance by (a) pain in 1 or both knees on most days of the month; b) self reported difficulty performing at least one or more tasks due to pain: stair climbing, rising from a chair, walking or running a quarter mile, repetitive movements such as kneeling or squatting or stooping, pain that inhibits job performance and daily activities;
  • Military service member at the time of injury (active duty military and Reserve/ National Guard in active duty status);
  • Age ≥18 and ≤50 years;
  • Ability to provide freely given informed consent.

Exclusion Criteria:

  • Fracture or injury to external knee structures such that knee extension or flexion is impaired;
  • Evidence of a fracture on radiographs or clinical evidence of unstable tendon tear/rupture;
  • A significant co-morbid medical condition (such as severe hypertension or neurological disorder in which NMES strength training or unsupervised exercise is contraindicated and would pose a safety threat or impair ability to participate;
  • Inability or unwillingness to participate in a walking or strengthening program;
  • Inability to speak and/or read English;
  • Reduced sensory perception in the lower extremities;
  • Inability to walk on a treadmill without an assistive device;
  • Vision impairment, where participant is classified as legally blind;
  • Unwillingness to accept random assignment;
  • Pregnancy;
  • A score of 23 or greater on the Center for Epidemiological Studies- Depression scale (CES-D);
  • If the person has a demand type implanted pacemaker or defibrillator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02065518

Contacts
Contact: Laura A Talbot, PhD 901-448-6113 ltalbot@uthsc.edu
Contact: Kyong Hyatt, PhD

Locations
United States, Maryland
Walter Reed National Military Medical Cener Recruiting
Bethesda, Maryland, United States, 20889
Principal Investigator: Kyong Hyatt, PhD         
Sponsors and Collaborators
University of Tennessee
Walter Reed National Military Medical Center
Investigators
Principal Investigator: Laura A Talbot, PhD, RN University of Tennessee Health Sciences Center
  More Information

No publications provided

Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT02065518     History of Changes
Other Study ID Numbers: HU0001-10-1-TS04, TSNRP Grant HU0001-10-1-TS04
Study First Received: February 12, 2014
Last Updated: June 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
Muscle strength
Electrical muscle stimulation
Strength training

Additional relevant MeSH terms:
Knee Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 30, 2014