- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07556003
Effect of Physical Therapy Rehabilitation on Gait and Plantar Pressure in Patients After Total Knee Replacement
Effect of Physical Therapy Rehabilitation on Gait Temporospatial Parameters and Plantar Pressure Distribution in Patients Following Total Knee Replacement Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hadeel Alsirhani, PhD
- Phone Number: +966556256464
- Email: hsalserhany@ju.edu.sa
Study Locations
-
-
-
Sakakah, Saudi Arabia, 72388
- Recruiting
- Jouf University and Prince Mutaib Bin Abdulaziz Hospital- Sakaka, AlJouf in Saudi Arabia
-
Contact:
- Hadeel Alsirhani, PhD
- Phone Number: 00966556256464
- Email: hsalserhany@ju.edu.sa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Post-TKR Group
|
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.
|
|
Experimental: Non-Surgical Group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cadence (steps/minute) measured using gait analysis system
Time Frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
|
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
Time Frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
|
kPa
|
Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
|
|
Postural Alignment
Time Frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
|
The REEDCO Posture Sheet
|
Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
|
|
Quadriceps Muscle Strength (MMT score 0-5)
Time Frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
|
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)
Time Frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
|
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)
Time Frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
|
m/sec
|
Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
|
|
Step and Stride time
Time Frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
|
Seconds
|
Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
|
|
Step and Stride length
Time Frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
|
cm
|
Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
|
|
Toe In/Out
Time Frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
|
Degree
|
Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
|
|
Base Of Support (BOS)
Time Frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
|
cm
|
Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
|
|
Average Pressure
Time Frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
|
kPa
|
Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
|
|
Gradient Pressure
Time Frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
|
kPa
|
Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
|
|
Hamstring Muscle Strength (MMT score 0-5)
Time Frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
|
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)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TKR-Gait-PT01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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