Knee OsteoarthritisNCT07556003
Effect of Physical Therapy Rehabilitation on Gait and Plantar Pressure in Patients After Total Knee Replacement
A study testing Physical Therapy Rehabilitation in people with Knee Osteoarthritis and Total Knee Replacement, run by Jouf University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Knee Osteoarthritis, Total Knee Replacement
- What is being tested?
- Physical Therapy Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Aug 2025to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Jouf University and Prince Mutaib Bin Abdulaziz Hospital- Sakaka, AlJouf in Saudi Arabia
Sakakah, 72388
Hadeel Alsirhani, PhD, 00966556256464, hsalserhany@ju.edu.sa
About this study
Official title: 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.
- Conditions
- Knee Osteoarthritis, Total Knee Replacement
- Being tested
- Physical Therapy Rehabilitation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Therapy RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Post-TKR Group | Experimental | Not described Receives: Other: Physical Therapy Rehabilitation |
| Non-Surgical Group | Experimental | Not described Receives: Other: Physical Therapy Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
Peak pressure
kPa
Measured: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
Postural Alignment
The REEDCO Posture Sheet
Measured: 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.
Measured: 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
Measured: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
Walking speed (velocity)
m/sec
Measured: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
Step and Stride time
Seconds
Measured: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
Step and Stride length
cm
Measured: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
Toe In/Out
Degree
Measured: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
Base Of Support (BOS)
cm
Measured: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
Average Pressure
kPa
Measured: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
Gradient Pressure
kPa
Measured: 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.
Measured: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start15 Aug 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jouf University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeel Saad Alsirhani, Jouf University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556003
- Sponsor's protocol ID
- TKR-Gait-PT01
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Therapy Rehabilitation on Gait Temporospatial Parameters and Plantar Pressure Distribution in Patients Following Total Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT07556003
- Acronym / sponsor ID
- TKR-Gait-PT01
- Conditions
- Knee Osteoarthritis, Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jouf UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-TKR Group | Experimental | Other: Physical Therapy Rehabilitation |
| Non-Surgical Group | Experimental | Other: Physical Therapy Rehabilitation |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Therapy RehabilitationA 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. | Other | Non-Surgical Group, Post-TKR Group |
Primary outcome
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.
Peak pressure
Time frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
kPa
Postural Alignment
Time frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
The REEDCO Posture Sheet
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.
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
Walking speed (velocity)
Time frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
m/sec
Step and Stride time
Time frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
Seconds
Step and Stride length
Time frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
cm
Toe In/Out
Time frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
Degree
Base Of Support (BOS)
Time frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
cm
Average Pressure
Time frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
kPa
Gradient Pressure
Time frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)
kPa
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy Rehabilitation in people with Knee Osteoarthritis and Total Knee Replacement, run by Jouf University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hadeel Alsirhani, PhD (+966556256464, hsalserhany@ju.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cadence (steps/minute) measured using gait analysis system (time frame: Baseline and after completion of the rehabilitation program (e.g., 6-10 weeks)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.