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Gender Based Comparison of the Effects of Sensory Modulated Graded Weight Bearing Physiotherapy In Adults With Knee Osteoarthritis

Gender Based Comparison of the Effects of Sensory Modulated Graded Weight Bearing Physiotherapy In Adults With Knee Osteoarthritis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07784998
Acronym
GSMGWBP
Enrollment
52
Registered
2026-08-25
Start date
2026-07-13
Completion date
2026-09-23
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthristis

Keywords

Knee Osteoarthritis, Sensory-Modulated Graded Weight-Bearing Physiotherapy, Physiotherapy, Rehabilitation, Pain, WOMAC, Proprioception, Six-Minute Walk Test, SF-36, Gender Differences

Brief summary

This comparative experimental study aims to evaluate the effectiveness of Sensory-Modulated Graded Weight-Bearing Physiotherapy (SMGWBP) in patients with knee osteoarthritis and compare treatment outcomes between male and female participants. Participants will receive a 6-week physiotherapy program with assessments conducted at baseline (pre-intervention), mid-intervention (3 weeks), and post-intervention (6 weeks) using validated outcome measures.

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.

Interventions

BEHAVIORALSensory-Modulated Graded Weight-Bearing Physiotherapy

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.

Sponsors

Shifa Tameer-e-Millat University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This study will evaluate the effect of Sensory Modulated Graded Weight Bearing Physiotherapy and compare the treatment response between male and female participants. The study will include two parallel groups: a male group and a female group. Both groups will receive the same physiotherapy intervention for 6 weeks. Outcomes will be assessed before and after the intervention to determine whether the effectiveness of the intervention differs between male and female participants.

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain Intensity Measured by the Visual Analog Scale (VAS), 0-10; lower scores indicate less painBaseline, Week 3, and Week 6To compare the effect of Sensory-Modulated Graded Weight-Bearing Physiotherapy on pain intensity between male and female patients with knee osteoarthritis
Change in Physical Function Measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale, 0-68; lower scores indicate better functionBaseline, Week 3, and Week 6To compare the effect of Sensory-Modulated Graded Weight-Bearing Physiotherapy on physical function between male and female patients with knee osteoarthritis
Change in Knee Joint Proprioception Measured by the Joint Position Sense (JPS) Test (absolute repositioning error in degrees; lower values indicate better proprioception)Baseline, Week 3, and Week 6To compare the effect of Sensory-Modulated Graded Weight-Bearing Physiotherapy on proprioception between male and female patients with knee osteoarthritis
Change in mobility Measured by the Six-Minute Walk Test (6MWT), distance walked in meters; higher values indicate better gait performanceBaseline, Week 3, and Week 6To compare the effect of Sensory-Modulated Graded Weight-Bearing Physiotherapy on mobility between male and female patients with knee osteoarthritis

Secondary

MeasureTime frameDescription
Change in Health-Related Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36), 0-100; higher scores indicate better health-related quality of lifeBaseline, Week 3, and Week 6To compare the effect of Sensory-Modulated Graded Weight-Bearing Physiotherapy on health-related quality of life between male and female patients with knee osteoarthritis

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026