Comparing the Effect of Toe-in Gait Modification Along With Conventional Physiotherapy in People With Medial KO

NCT06741033 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall22/758
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Medial knee osteoarthritis (OA) remains a prevalent and debilitating condition, despite conventional physiotherapy interventions aimed at reducing pain and improving function. This study investigates the additional benefits of toe-in gait modification when combined with conventional physiotherapy in individuals with medial knee OA. Rooted in biomechanical theories suggesting that altering gait patterns can reduce medial knee load, this research employs a randomized controlled trial methodology.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• NUMERIC PAIN RATING SCALE (NPRS)

  The NPRS is 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine

  12 Months

• WOMAC scale

  The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales (Pain, Stiffness, and Physical Function) The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score.

  12 Months

Study Arms (2)

Interventional group I

EXPERIMENTAL

Diagnostic Test: Conventional physiotherapy

Interventional group II

ACTIVE COMPARATOR

Combination Product: Toe-in gait modification

Interventions

Conventional physiotherapy DIAGNOSTIC_TEST

Conventional physiotherapy of medial knee osteoarthritis patients: Isometric exercises, strengthening exercises, stretching exercises and electrotherapy.

Interventional group I

Toe-in gait modification COMBINATION_PRODUCT

A specific alteration in walking pattern where the toes are directed inward during walking. This modification should be clearly defined, including the degree of inward rotation of the foot and how it is taught and monitored in participants. Toe-in gait modification basically includes decrease foot progression angle from baseline through internal foot rotation. Participants are instructed to increase the Toe-in angle of their study limb by 5 degree and walk at least 5-10 minutes (progressed to 15-20 min after 4 week) with this progression angle.

Interventional group II

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of MKOA having Grade 1-3 (radiographic evidence of MKOA)
• Knee pain on most days of previous month. (The most symptomatic side will consider the study limb for participants with bilaterally eligible knees)
• Age \> 45
• Ability to walk unaided for at least 25 min
• Gender eligibility both male and female

You may not qualify if:

• Severe MKOA (Grade 4)
• Lateral OA
• Patella femoral OA
• Previous or planned hip or knee surgery
• Hip or ankle arthritis
• Rheumatoid arthritis
• Severe valgus and varus alignment requiring the use of an assistive device and the inability to walk independently
• Neurological dysfunction

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Institute of orthopedic and rehabilitation IOR garden town

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: February 28, 2024
• Primary Completion: August 1, 2024
• Study Completion: March 1, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)