Trials / Completed
CompletedNCT02712710
Does Addition of a Functional Knee Brace Improve Rehabilitation Outcome in Subjects With Osteoarthritis of the Knee?
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Shin Kong Wu Ho-Su Memorial Hospital · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to investigate the effect of functional knee brace in the subjects with medial compartment knee OA.
Detailed description
20 subjects with symptomatic medial compartment knee OA, with grade 2 to 4 on Kellgren and Lawrence scale, and showing willing to wear a functional knee brace will be recruited into this study. Another 20 subjects with comparable body height, weight, and sex will be served as a control group. All of the subjects received 4 weeks' rehabilitation treatment (3 times a week). VAS pain score, WOMAC index, and SF-36 will be evaluated before the treatment, and 1 month, and 3 months after the start of treatment. Patients' satisfaction will be evaluated at 1 month, and 3 months after start of treatment. Patients' compliance and any adverse events due to wearing of the functional knee brace will also be reported. A 2-by-3, 2-way mixed-model analysis of variance, which had 1 between-subject factor (group: knee brace + PT and PT only) and 1 within subject factor (evaluation time:T0, T1, T2) , was performed. Pair-wise comparisons between groups were performed using an independent t test (if in normal distribution) or Mann-Whitney U test (if not in normal distribution). Investigators hypothesize that addition of a functional knee brace would improve rehabilitation outcome in subjects with knee OA.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | functional knee brace | The functional knee brace for OA can decrease abnormal varus torque by external force. |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2016-12-01
- Completion
- 2017-10-01
- First posted
- 2016-03-18
- Last updated
- 2020-12-23
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT02712710. Inclusion in this directory is not an endorsement.