Effects of Two Bar Knee Off-Load Brace With Non Weight Bearing Strength Training Among Knee Osteoarthritis Patients

Sponsor
Lahore University of Biological and Applied Sciences
Study ID
NCT07562646
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Two-Bar Knee Off-Load Brace with Non-Weight Bearing Strength Training Intervention — OTHER
    Participants will be instructed to wear the two-bar knee off-loader brace during waking hours. Participants will be advised not to wear the brace during sleep, bathing, or personal hygiene activities, and to remove it during prolonged periods of sitting or lying down. Daily skin inspection will be recommended to monitor for discomfort or irritation. The Non-Weight Bearing Strength Training is a structured program of strengthening and stretching exercises for the lower extremities. The strength training will be administered three times per week throughout the six-week intervention period. Each treatment session will begin with 10 minutes warm-up, followed by resistance training, and ending with 10 minutes cool-down. The overall session duration is expected to range between 45 and 60 minutes. Rest intervals of 20-30 seconds will be provided between sets, with a 1-minute rest period before transitioning to the next exercise.
  • Standard Knee Off-Loader Brace with Non-Weight Bearing Strength Training Intervention — OTHER
    Participants in the control group will receive the same non-weight bearing strength training program along with the use of a standard knee off-loader brace. The strengthening program will target hip, knee, and ankle muscles and will be performed in non-weight bearing positions to minimize joint stress while improving muscular strength and joint stability.

Study Details

The current study is a single-blind, parallel-group randomized controlled trial involving 18 participants with knee osteoarthritis. The trial will compare a program of two-bar knee off-load brace combined with non-weight bearing strength training with a program of standard knee off-loader brace combined with non-weight bearing strength training. Interventions will be delivered three times per week for six weeks. The primary outcomes are pain, stiffness, and patient satisfaction. Assessments will be conducted at baseline and after six weeks. The trial will be carried out at Water and Power Development Authority Hospital Complex and Fatima Memorial Hospital, Lahore. The hypothesis is that the two-bar knee off-load brace combined with non-weight bearing strength training will result in greater reductions in pain and stiffness as well as improved patient satisfaction compared with the standard knee off-loader brace with non-weight bearing strength training.

Key Dates

First listed
May 1, 2026
Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Two-Bar Knee Off-Load Brace Group
    The two-bar knee off-load brace is designed with medial and lateral rigid support bars that partially bear axial load and reduce compressive forces on the knee joint during weight-bearing activities. Participants will also perform a structured non-weight bearing strengthening program targeting the hip, knee, and ankle muscles.
  • Active Comparator: Standard Knee Off-Loader Brace Group
    The standard brace redistributes joint forces within the knee joint but does not provide external axial load support. Participants will perform the same non-weight bearing strengthening exercises as the experimental group.

Primary Outcome Measure

Knee Pain [ Time Frame: From enrollment to the end of treatment at 6 weeks ]

Central Contacts

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