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

NCT02712710 | Completed DMC

• 2 other identifiers: 20140714RSKH-8302-104-DR-30
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effect of functional knee brace in the subjects with medial compartment knee OA.

Conditions

Knee Osteoarthritis

Keywords

knee, osteoarthritis, brace

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Secondary Outcomes (2)

• WOMAC index

  1 month

• SF-36

  1 month

Study Arms (2)

wear a functional knee brace

EXPERIMENTAL

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)

Device: functional knee brace

no wear a functional knee brace

NO INTERVENTION

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

Interventions

functional knee brace DEVICE

The functional knee brace for OA can decrease abnormal varus torque by external force.

wear a functional knee brace

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 31204145 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Lin-Fen Hsieh, M.D

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: March 18, 2016
• Study Start: October 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: October 1, 2017
• Last Updated: December 23, 2020

Record last verified: 2017-01

Locations

TW (1)