NCT07784998

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Jul 2026Sep 2026

Study Start

First participant enrolled

July 13, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 17, 2026

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2026

Expected
Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

1 month

First QC Date

August 17, 2026

Last Update Submit

August 19, 2026

Conditions

Keywords

Knee OsteoarthritisSensory-Modulated Graded Weight-Bearing PhysiotherapyPhysiotherapyRehabilitationPainWOMACProprioceptionSix-Minute Walk TestSF-36Gender Differences

Outcome Measures

Primary Outcomes (4)

  • Change in Pain Intensity Measured by the Visual Analog Scale

    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

    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

    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)

    To assess changes in gait performance following Sensory Modulated Graded Weight-Bearing Physiotherapy

    Baseline, Week 3, and Week 6

Secondary Outcomes (2)

  • Change in Health-Related Quality of Life Measured by the Short Form-36 (SF-36)

    Baseline, Week 3, and Week 6

  • Treatment Compliance

    At the end of the 6 week intervention

Study Arms (2)

Arm 1 - Arm Title: Male Participants

EXPERIMENTAL

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.

Behavioral: Sensory-Modulated Graded Weight-Bearing Physiotherapy

Arm 2 - Arm Title: Female Participants

EXPERIMENTAL

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.

Behavioral: Sensory-Modulated Graded Weight-Bearing Physiotherapy

Interventions

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.

Arm 1 - Arm Title: Male ParticipantsArm 2 - Arm Title: Female Participants

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

T.H.Q hospital

Gujar Khan, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneePain

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 17, 2026

First Posted

August 25, 2026

Study Start

July 13, 2026

Primary Completion

August 24, 2026

Study Completion (Estimated)

September 23, 2026

Last Updated

August 25, 2026

Record last verified: 2026-08

Locations