Effect of Knee and Heel Off-Loader Brace With Non Weight Bearing Strength in Knee Osteoarthritis

NCT07562685 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-01

No results posted yet for this study

Summary

The current study is a single-blinded, parallel-group pilot randomized controlled trial involving 20 participants diagnosed with knee osteoarthritis (KOA). The trial will compare the effects of a knee and heel off-loader brace combined with non-weight bearing (NWB) strength training versus a conventional knee off-loader brace combined with NWB strength training. Interventions will be delivered three times per week for four weeks.

The primary outcome of the study is pain intensity, while secondary outcomes include gait variability and functional outcome. Assessments will be conducted at baseline and after completion of the intervention period. The study will be carried out at the outpatient physiotherapy departments of Kaazi Hospital and Ghurki Trust Hospital, Lahore.

The hypothesis is that the combination of knee and heel off-loader brace with NWB strength training will result in greater reductions in pain, improved gait variability, and enhanced functional outcomes compared to the conventional knee off-loader brace with NWB strength training.

Conditions

  • Knee Osteoarthristis

Interventions

DEVICE

Knee and Heel Off-Loader Brace with NWB Strength Training

Participants in the experimental group will receive a combined intervention of knee and heel off-loader brace along with a structured NWB strength training program. The exercise program will be conducted three times per week for four weeks, with each session lasting approximately 45-60 minutes. Exercises will include quadriceps isometrics, straight leg raises, short arc quadriceps, hamstring curls, hip abduction, and glute bridging. Progression will be based on patient tolerance.

DEVICE

Conventional Knee Off-Loader Brace with NWB Strength Training

Participants in the control group will receive a conventional knee off-loader brace combined with the same NWB strength training program instead of Knee and Heel Off-Loader Brace .

Sponsors & Collaborators

  • Lahore University of Biological and Applied Sciences

    lead OTHER

Principal Investigators

  • Muhammad Tariq Rafiq, PhD · Lahore University of Biological & Applied Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2026-06-30
Completion
2026-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07562685 on ClinicalTrials.gov