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NCT Number: NCT07784998

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

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.

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

T.H.Q hospital

Gujar Khan, Punjab Province, Pakistan

Location status: Recruiting

Location contact

Dr.Sarmaad Kayyani, MBBS

CONTACT

[email protected]

+923005088112

Sadia Akhtar, DPT

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sensory-Modulated Graded Weight-Bearing Physiotherapy

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Shifa Tameer-e-Millat University

Other

Registry information

Acronym: GSMGWBP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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