- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07784998
Gender Based Comparison of the Effects of Sensory Modulated Graded Weight Bearing Physiotherapy In Adults With Knee Osteoarthritis (GSMGWBP)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Knee osteoarthritis (KOA) is a common degenerative joint disorder associated with pain, impaired physical function, reduced proprioception, decreased mobility, and poor quality of life. Physiotherapy plays a central role in the conservative management of KOA by reducing pain and improving functional performance. Sensory-Modulated Graded Weight-Bearing Physiotherapy (SMGWBP) integrates sensory stimulation with progressive weight-bearing exercises to enhance neuromuscular control, balance, proprioception, and functional recovery.
This comparative experimental study aims to evaluate the effectiveness of SMGWBP in individuals with Kellgren-Lawrence grade II or III knee osteoarthritis and to compare treatment outcomes between male and female participants. A total of 52 participants will be recruited through purposive sampling. All participants will receive a standardized 6-week physiotherapy program consisting of three supervised sessions per week.
Outcome assessments will be performed at three time points: baseline (pre-intervention), mid-intervention (3 weeks), and post-intervention (6 weeks). The primary and secondary outcome measures include pain intensity measured using the Visual Analog Scale (VAS), physical function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), proprioception using the Joint Position Sense (JPS) test, gait performance using the Six-Minute Walk Test (6MWT), health-related quality of life using the Short Form-36 (SF-36), and treatment compliance. The study will examine changes in these outcomes over time and compare the effectiveness of the intervention between male and female participants.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Gujar Khan, Punjab Province, Pakistan
- Recruiting
- T.H.Q hospital
-
Contact:
- Dr.Sarmaad Kayyani, MBBS
- Phone Number: +923005088112
- Email: Sarmaadkayyani@gmail.com
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Principal Investigator:
- Sadia Akhtar, DPT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion criteria
- Participants are eligible for inclusion if they meet the following criteria:
- Age between 40 and 60 years.
- Diagnosed with Grade II or Grade III Knee Osteoarthritis according to Kellgren-Lawrence Classification.
- Ability to ambulate independently without assistive devices.
- Mild to moderate pain intensity with a Visual Analogue Scale score less than seven.
- Ability to understand and follow instructions.
- Willingness to participate and provide written informed consent. Exclusion Criteria
- Participants are excluded if they meet any of the following criteria:
- History of knee surgery within the previous six months.
- Neurological disorders affecting balance, gait, or proprioception.
- Severe cardiovascular disease limiting participation in exercise.
- Rheumatoid arthritis or other inflammatory arthritic conditions.
- Severe cognitive impairment.
- Any medical condition that contraindicates participation in rehabilitation exercises.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1 - Arm Title: Male Participants
Twenty-six male participants with knee osteoarthritis will receive the Sensory-Modulated Graded Weight-Bearing Physiotherapy Programme for six weeks, with three supervised sessions per week.
Outcomes will be assessed at baseline, Week 3, and Week 6.
|
A structured six-week Sensory-Modulated Graded Weight-Bearing Physiotherapy Programme consisting of three supervised sessions per week (18 sessions total).
Each session includes warm-up, sensory modulation, proprioceptive training, graded weight-bearing strengthening, functional mobility exercises, and cool-down activities.
The programme progresses through three phases: Weeks 1-2 focus on sensory activation and proprioceptive training; Weeks 3-4 on graded weight-bearing strengthening; and Weeks 5-6 on functional weight-bearing integration.
Exercises are progressed according to participant tolerance, pain severity, and functional performance.
Both male and female groups receive the same intervention.
|
|
Experimental: Arm 2 - Arm Title: Female Participants
Twenty-six female participants with knee osteoarthritis will receive the Sensory-Modulated Graded Weight-Bearing Physiotherapy Programme for six weeks, with three supervised sessions per week.
Outcomes will be assessed at baseline, Week 3, and Week 6.
|
A structured six-week Sensory-Modulated Graded Weight-Bearing Physiotherapy Programme consisting of three supervised sessions per week (18 sessions total).
Each session includes warm-up, sensory modulation, proprioceptive training, graded weight-bearing strengthening, functional mobility exercises, and cool-down activities.
The programme progresses through three phases: Weeks 1-2 focus on sensory activation and proprioceptive training; Weeks 3-4 on graded weight-bearing strengthening; and Weeks 5-6 on functional weight-bearing integration.
Exercises are progressed according to participant tolerance, pain severity, and functional performance.
Both male and female groups receive the same intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pain Intensity Measured by the Visual Analog Scale
Time Frame: Baseline, Week 3, and Week 6
|
To evaluate the change in pain intensity following a 6-week Sensory-Modulated Graded Weight Bearing Physiotherapy program in patients with knee osteoarthritis.
|
Baseline, Week 3, and Week 6
|
|
Change in Physical Function Measured by the Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame: Baseline, Week 3, and Week 6
|
To assess changes in physical function following Sensory-Modulated Graded Weight-Bearing Physiotherapy.
|
Baseline, Week 3, and Week 6
|
|
Change in Proprioception Measured by the Joint Position Sense (JPS) Test
Time Frame: Baseline, Week 3, and Week 6
|
To assess changes in knee joint proprioception following Sensory Modulated Graded Weight-Bearing Physiotherapy
|
Baseline, Week 3, and Week 6
|
|
Change in Gait Performance Measured by the Six-Minute Walk Test (6MWT)
Time Frame: Baseline, Week 3, and Week 6
|
To assess changes in gait performance following Sensory Modulated Graded Weight-Bearing Physiotherapy
|
Baseline, Week 3, and Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Health-Related Quality of Life Measured by the Short Form-36 (SF-36)
Time Frame: Baseline, Week 3, and Week 6
|
To assess changes in health-related quality of life following Sensory-Modulated Graded Weight-Bearing Physiotherapy
|
Baseline, Week 3, and Week 6
|
|
Treatment Compliance
Time Frame: At the end of the 6 week intervention
|
To assess participants adherence to the prescribed 6-week Sensory Modulated Graded Weight Bearing Physiotherapy program.
Treatment compliance determine based on the percentage of complete supervised treatment session
|
At the end of the 6 week intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 189-26
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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