Effect of Physical Therapy Rehabilitation on Gait and Plantar Pressure in Patients After Total Knee Replacement

NCT07556003 | Recruiting

• 1 other identifier: TKR-Gait-PT01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effects of a structured physical therapy and rehabilitation program on gait temporospatial parameters and plantar pressure distribution in patients who have undergone total knee replacement surgery. Patients undergoing total knee replacement often experience alterations in gait patterns and weight distribution, which may affect functional mobility and recovery outcomes. This study will evaluate whether a targeted rehabilitation program can improve walking performance and restore more symmetrical plantar pressure distribution. Participants will be assessed before and after the intervention using objective gait analysis and plantar pressure measurement tools. The findings of this study may help improve rehabilitation strategies and enhance functional recovery following knee replacement surgery.

Conditions

Knee Osteoarthritis; Total Knee Replacement

Outcome Measures

Primary Outcomes (13)

• Cadence (steps/minute) measured using gait analysis system

  Cadence will be measured using a gait analysis system. The average number of steps per minute will be calculated for each participant.

  Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)

• Peak pressure

  kPa

  Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)

• Postural Alignment

  The REEDCO Posture Sheet

  Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)

• Quadriceps Muscle Strength (MMT score 0-5)

  Muscle strength will be assessed using Manual Muscle Testing (MMT) graded from 0 to 5.

  Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)

• Circular measurement of quadriceps (cm)

  To evaluate the degree of muscle wasting (atrophy), hypertrophy, or the degree of oedema and joint swelling

  Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)

• Walking speed (velocity)

  m/sec

  Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)

• Step and Stride time

  Seconds

  Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)

• Step and Stride length

  cm

  Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)

• Toe In/Out

  Degree

  Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)

• Base Of Support (BOS)

  cm

  Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)

• Average Pressure

  kPa

  Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)

• Gradient Pressure

  kPa

  Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)

• Hamstring Muscle Strength (MMT score 0-5)

  Muscle strength will be assessed using Manual Muscle Testing (MMT) graded from 0 to 5.

  Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)

Study Arms (2)

Post-TKR Group

EXPERIMENTAL

Other: Physical Therapy Rehabilitation

Non-Surgical Group

EXPERIMENTAL

Other: Physical Therapy Rehabilitation

Interventions

Physical Therapy Rehabilitation OTHER

A structured physical therapy rehabilitation program including range of motion exercises, muscle strengthening, balance training, and gait training aimed at improving functional mobility and gait performance.

Non-Surgical Group; Post-TKR Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants aged between 40 and 70 years
• Patients who have undergone unilateral total knee replacement (TKR) or have knee pathology without surgical intervention
• Ability to walk independently with or without assistive devices
• Medically stable and able to participate in a physical therapy rehabilitation program

You may not qualify if:

• Neurological disorders affecting gait (e.g., stroke, Parkinson's disease)
• Severe musculoskeletal disorders other than knee pathology
• History of revision knee replacement surgery
• Significant cognitive impairment affecting the ability to follow instructions
• Any contraindications to physical therapy rehabilitation

Sponsors & Collaborators

• Jouf University: lead

Study Sites (1)

Jouf University and Prince Mutaib Bin Abdulaziz Hospital- Sakaka, AlJouf in Saudi Arabia

Sakakah, 72388, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hadeel Alsirhani, PhD

CONTACT

+966556256464; hsalserhany@ju.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This study is conducted as an open-label trial. Due to the nature of the physical therapy intervention, neither participants nor care providers are blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 29, 2026
• Study Start: August 15, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

SA (1)