N/A
N=78
Electromyostimulation and Strength Walking for Knee Injuries
Knee Injury
Bottom Line
View on ClinicalTrials.gov: NCT02065518 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Lower Extremity Muscle Strength- Extension — 27.5; 32.6; 32.1; 24.3 Kilograms
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NMES (Device); Strength Walking (Behavioral); Standard Rehabilitation Protocol (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Tennessee
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lower Extremity Muscle Strength- Extension |
27.5; 32.6; 32.1; 24.3; 25.4; 32 | — |
| PRIMARY Lower Extremity Muscle Strength- Flexion |
16.2; 16.6; 16.2; 13.7; 15.3; 16.9 | — |
| PRIMARY Lower Extremity Mobility- 6-Minute Walk Test |
19800; 20224; 19728; 18974; 21822; 21696 | — |
| PRIMARY Lower Extremity Strength- Chair Test |
11.3; 11.4; 12.7; 10.7; 12.7; 13.6 | — |
| PRIMARY Lower Extremity Mobility and Endurance- Step Test |
189; 162; 199; 172; 185; 178 | — |
| SECONDARY Overall Pain Severity |
5.4; 4.9; 5.7; 5.1; 5.9; 5 | — |
| SECONDARY Knee Pain Following Performance Testing- 6-Minute Walk Test |
2.4; 2.9; 1.8; 2.5; 3.2; 1.6 | — |
| SECONDARY Knee Pain Following Performance Testing- Chair Stand Test |
3.7; 2.5; 2.1; 2.7; 3.5; 1.4 | — |
| SECONDARY Knee Pain Following Performance Testing- 2-Minute Step Test |
4.0; 3.7; 3.0; 3.7; 3.5; 2.1 | — |
| SECONDARY Activities of Daily Living- Knee Symptoms |
25.4; 23.3; 25.1; 22.9; 25.0; 24.6 | — |
| SECONDARY Activities of Daily Living- Activity Limitation |
32.9; 30.9; 30.9; 31.5; 33.4; 33.3 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02065518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.