Clinical Trials Directory

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

TypeNameDescription
DEVICEfunctional knee braceThe 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.

Does Addition of a Functional Knee Brace Improve Rehabilitation Outcome in Subjects With Osteoarthritis of the Knee? (NCT02712710) · Clinical Trials Directory