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Does Addition of a Functional Knee Brace Improve Rehabilitation Outcome in Subjects With Osteoarthritis of the Knee?

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
functional knee brace
Sponsored by
Shin Kong Wu Ho-Su Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee, osteoarthritis, brace

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

According to the American College of Rheumatology (American College of Rheumatology) diagnosis of unilateral medial knee osteoarthritis, according to Kellgren and Lawrence X-rays are classified as two to four acceptable month rehabilitation therapy, and for the first time dressed Thruster Legacy's functional knee brace. The control group of patients with knee osteoarthritis same conditions, but dressed Thruster Legacy functional knee brace.

Exclusion Criteria:

  1. have undergone knee surgery
  2. the lateral tibiofemoral joint severe (tibio-femoral joint) disease
  3. serious knee ligament laxity
  4. knee flexion contracture (flexion contracture) than 20 degrees
  5. unable to walk
  6. the skin of metal (aluminum) allergy
  7. lower extremity vascular lesions or swelling

Sites / Locations

  • Shin Kong Wu Ho-Su Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

wear a functional knee brace

no wear a functional knee brace

Arm 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. All of the subjects received 4 weeks' rehabilitation treatment (3 times a week)

Another 20 subjects with comparable body height, weight, and sex. All of the subjects received 4 weeks' rehabilitation treatment (3 times a week)

Outcomes

Primary Outcome Measures

VAS pain score
To the severity of the pain patients experience pain in itself to make a quantitative expression, assessment methods as follows: a horizontal line 10 cm in length, with zero as the most left office, on behalf of completely pain-free; the far right of the line can imagine the most severe pain, subjects were at rest and walking, according to their degree of sense of pain marked on the straight line. Reliability of this scale up to 0.94.

Secondary Outcome Measures

WOMAC index
Western Ontario McMaster University Osteoarthritis Index (WOMAC Index) is the most commonly used assessment study of knee osteoarthritis by functional scales, including pain, stiffness and function of physical activity and other three items. You can use the record score VAS (visual analog scale) or scale from 0 to 4 five scale. A total of 24 projects, of which pain part 5 projects, while the stiffness and joint function. 2 and 17 projects each. The total score of 100 points, higher scores indicate worse situation. WOMAC for assessing knee osteoarthritis has good reliability and validity.
SF-36
The SF-36 is a 36-item questionnaire that evaluates the quality of life. It is composed of 8 subscales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each subscale has a score range of 0 to 100, with a higher score indicating better health status.Patient's evaluation of the treatment effect. Patient's evaluation of the treatment effect consists of the answer to one question: "Is the treatment effective?" scored on a Likert scale (very effective=1, effective=2, not effective=3, worse=4, much worse=5).

Full Information

First Posted
November 24, 2014
Last Updated
December 22, 2020
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02712710
Brief Title
Does Addition of a Functional Knee Brace Improve Rehabilitation Outcome in Subjects With Osteoarthritis of the Knee?
Official Title
Does Addition of a Functional Knee Brace Improve Rehabilitation Outcome in Subjects With Osteoarthritis of the Knee?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shin Kong Wu Ho-Su Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee, osteoarthritis, brace

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
wear a functional knee brace
Arm Type
Experimental
Arm 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. All of the subjects received 4 weeks' rehabilitation treatment (3 times a week)
Arm Title
no wear a functional knee brace
Arm Type
No Intervention
Arm Description
Another 20 subjects with comparable body height, weight, and sex. All of the subjects received 4 weeks' rehabilitation treatment (3 times a week)
Intervention Type
Device
Intervention Name(s)
functional knee brace
Intervention Description
The functional knee brace for OA can decrease abnormal varus torque by external force.
Primary Outcome Measure Information:
Title
VAS pain score
Description
To the severity of the pain patients experience pain in itself to make a quantitative expression, assessment methods as follows: a horizontal line 10 cm in length, with zero as the most left office, on behalf of completely pain-free; the far right of the line can imagine the most severe pain, subjects were at rest and walking, according to their degree of sense of pain marked on the straight line. Reliability of this scale up to 0.94.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
WOMAC index
Description
Western Ontario McMaster University Osteoarthritis Index (WOMAC Index) is the most commonly used assessment study of knee osteoarthritis by functional scales, including pain, stiffness and function of physical activity and other three items. You can use the record score VAS (visual analog scale) or scale from 0 to 4 five scale. A total of 24 projects, of which pain part 5 projects, while the stiffness and joint function. 2 and 17 projects each. The total score of 100 points, higher scores indicate worse situation. WOMAC for assessing knee osteoarthritis has good reliability and validity.
Time Frame
1 month
Title
SF-36
Description
The SF-36 is a 36-item questionnaire that evaluates the quality of life. It is composed of 8 subscales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each subscale has a score range of 0 to 100, with a higher score indicating better health status.Patient's evaluation of the treatment effect. Patient's evaluation of the treatment effect consists of the answer to one question: "Is the treatment effective?" scored on a Likert scale (very effective=1, effective=2, not effective=3, worse=4, much worse=5).
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: According to the American College of Rheumatology (American College of Rheumatology) diagnosis of unilateral medial knee osteoarthritis, according to Kellgren and Lawrence X-rays are classified as two to four acceptable month rehabilitation therapy, and for the first time dressed Thruster Legacy's functional knee brace. The control group of patients with knee osteoarthritis same conditions, but dressed Thruster Legacy functional knee brace. Exclusion Criteria: have undergone knee surgery the lateral tibiofemoral joint severe (tibio-femoral joint) disease serious knee ligament laxity knee flexion contracture (flexion contracture) than 20 degrees unable to walk the skin of metal (aluminum) allergy lower extremity vascular lesions or swelling
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin-Fen Hsieh, M.D
Organizational Affiliation
Shin Kong Wu Ho-Su Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
31204145
Citation
Hsieh LF, Lin YT, Wang CP, Liu YF, Tsai CT. Comparison of the effect of Western-made unloading knee brace with physical therapy in Asian patients with medial compartment knee osteoarthritis-A preliminary report. J Formos Med Assoc. 2020 Jan;119(1 Pt 2):319-326. doi: 10.1016/j.jfma.2019.05.024. Epub 2019 Jun 13.
Results Reference
derived

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Does Addition of a Functional Knee Brace Improve Rehabilitation Outcome in Subjects With Osteoarthritis of the Knee?

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