Electromyostimulation and Strength Walking for Knee Injuries
KI
2 other identifiers
interventional
78
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedResults Posted
Study results publicly available
August 14, 2019
CompletedAugust 28, 2019
October 1, 2018
2.4 years
February 12, 2014
July 23, 2019
August 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Lower Extremity Muscle Strength- Extension
Muscle strength was measured with a handheld dynamometer for extensor knee strength of the injured and uninjured knee.
0, 3, 6, 9, 12, and 18 weeks
Lower Extremity Muscle Strength- Flexion
Muscle strength was measured with a handheld dynamometer for flexor knee strength of the injured and uninjured knee.
0, 3, 6, 9, 12, and 18 weeks
Lower Extremity Mobility- 6-Minute Walk Test
Mobility was measured by the distance walked at a fast pace over 6-minutes,
0, 6, 12, and 18 weeks
Lower Extremity Strength- Chair Test
Mobility was measured by the number of complete standing and sitting cycles in 30-seconds
0, 6, 12, and 18 weeks
Lower Extremity Mobility and Endurance- Step Test
Mobility and endurance were measured by the number of up and down step cycles completed in 2-minutes.
0, 6, 12, and 18 weeks
Secondary Outcomes (6)
Overall Pain Severity
0, 3, 6, 9, 12, and 18 weeks
Knee Pain Following Performance Testing- 6-Minute Walk Test
0, 6, 12, and 18 weeks
Knee Pain Following Performance Testing- Chair Stand Test
0, 6, 12, and 18 weeks
Knee Pain Following Performance Testing- 2-Minute Step Test
0, 6, 12, and 18 weeks
Activities of Daily Living- Knee Symptoms
0, 3, 6, 9, 12, and 18 weeks
- +1 more secondary outcomes
Study Arms (4)
Standard Rehabilitation Protocol (SRP)
ACTIVE COMPARATORAll participants will receive the current standard of care, the physical therapy rehabilitation protocol for knee injuries at the WRNMMC and MGMCSC sites. This program includes treatment supervised by a physical therapist at the physical therapy clinics.
NMES w/ SRP
EXPERIMENTALIn addition to the standard 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).
Strength Walking w/ SRP
EXPERIMENTALThe 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 weighted vest to begin the strengthening component.
NMES/Strength Walking w/ SRP
EXPERIMENTALIn addition to the standard 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Malcolm Grow Medical Clinics and Surgery Center
Andrews Air Force Base, Maryland, 20762, United States
Walter Reed National Military Medical Cener
Bethesda, Maryland, 20889, United States
Related Publications (3)
Talbot LA. (2016). Electromyostimulation and Strength Walking for Knee Injuries: Nurse Managed Care. 19 p, NTIS Report No.: PB2017102173.
BACKGROUNDTalbot LA, Brede E, Price MN, Zuber PD, Metter EJ. Self-Managed Strength Training for Active Duty Military With a Knee Injury: A Randomized Controlled Pilot Trial. Mil Med. 2019 Jul 1;184(7-8):e174-e183. doi: 10.1093/milmed/usy347.
PMID: 30690578RESULTTalbot LA, Brede E, Price M, Metter EJ. Health-related quality of life in active duty military: A secondary data analysis of two randomized controlled trials. Nurs Outlook. 2017 Sep-Oct;65(5S):S53-S60. doi: 10.1016/j.outlook.2017.07.010. Epub 2017 Jul 25.
PMID: 28830632DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Laura Talbot
- Organization
- University of Tennessee Health Science Center
Study Officials
- PRINCIPAL INVESTIGATOR
Laura A Talbot, PhD, RN
University of Tennessee Health Sciences Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2014
First Posted
February 19, 2014
Study Start
March 1, 2014
Primary Completion
August 1, 2016
Study Completion
August 1, 2018
Last Updated
August 28, 2019
Results First Posted
August 14, 2019
Record last verified: 2018-10