- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05959902
Effectiveness of Physical Therapy in Stem Cell Transplant Recipients for Knee Osteoarthritis
Effectiveness of Physical Therapy on Stem Cell Transplantation Recipients in Improving Pain, Quadriceps Muscle Strength and Functional Status of Knee Osteoarthritis: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Syed Muhammad Zaeem Hasan Zaidi, DPT
- Phone Number: 03320319277
- Email: hxaeem@gmail.com
Study Contact Backup
- Name: Farhan I Khan, PhD
- Phone Number: 03332209704
- Email: farhan.ishaque@duhs.edu.pk
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 74200
- Recruiting
- Dow Institute of Physical Medicine and Rehabilitation, DUHS.
-
Contact:
- Syed Muhammad Zaeem Hasan Zaidi, DPT
- Phone Number: 03320319277
- Email: hxaeem@gmail.com
-
Karachi, Sindh, Pakistan
- Recruiting
- Alkhaleej Ortho Stem Cell Clinic
-
Contact:
- Syed Muhammad Zaeem Hasan Zaidi, DPT
- Phone Number: 03320319277
- Email: hxaeem@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects of age 40 years and above.
- Male and female both will be included.
- Patients with single or both knee OA.
- Patients who had mesenchymal stem cell transplantation.
- Kellgren and Lawrence grade II, III on radiological findings.
Exclusion Criteria:
- Patients with any neurological disorder.
- Any musculoskeletal deformity (varus/valgus).
- Patients who have had any type of lower limb internal fixation.
- Patients who have had any type of lower limb arthroplasty or other knee surgery in the past.
- Patients with a history of any infectious or malignant condition.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Forward Walking
This study ARM will receive following treatment in home program after mesenchymal stem cell treatment. • Forward Walking |
During the 8-week treatment, the participants will undertake 10 minutes of forward walking, as well as a 5-minute warm-up and cool-down, three times a week on an even surface at their normal speed as a home exercise plan.
During the warmup and cool down periods, the participants were advised to execute ankle toe motions, heel lift exercises, and hamstring and gastrocnemius-soleus stretches.
|
Experimental: Physiotherapy
This study ARM will be receiving following physiotherapy exercises for knee osteoarthritis after mesenchymal stem cell therapy.
|
Isometric quadriceps exercise. Straight leg raising (SLR) exercise. Isometric hip adduction exercise. Terminal knee extension exercise: Semi-wall squat exercise. Quadriceps drill exercise. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee Injury and Osteoarthritis Outcome Score (change is being assessed)
Time Frame: Baseline and 8 weeks
|
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a self reported specific joint measure developed to assess a broad spectrum of patients with knee injuries and OA, for pain and other symptoms, function in daily life, function in sports and recreation, and quality of knee-related life, being easy to use, evaluating the short- and long-term health problems related to the knee joint. The Knee injury and Osteoarthritis Outcome Score contains 42 items covering five subscales: pain, other symptoms, activities of daily living, sports/recreation, and quality of life. A patient's maximum score is 100, which indicates that they have no knee concerns. The lowest possible score is 0, which indicates serious knee issues. |
Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analog scale (change is being assessed)
Time Frame: Baseline and 8 weeks
|
It measures the subjective of pain ranges from 10-cm lines with defined cut off scores.
The correlation between vertical and horizontal orientations of the VAS is 0.99 .
Aggregate score ranges for this screening tool starting with 0-10.
Scores between 0-4 means mild pain.
Scores between 4-7 indicates moderate pain.
Scores between 7-10 means severe pain.
pain severity will be assessed at rest and during stairs ascending and descending
|
Baseline and 8 weeks
|
Manual Muscle Testing (change is being assessed)
Time Frame: Baseline and 8 weeks
|
It is used to assess weakness and is capable of distinguishing actual weakness from imbalance or insufficient endurance.
Muscle strength testing is used to assess a complaint of weakness, which commonly occurs when a suspected neurologic condition or muscle weakness is present.
The Oxford Scale is the most widely used way of determining muscle strength (AKA Medical Research Council Manual Muscle Testing scale).
This method entails putting important muscles in the upper and lower limbs to the test against the examiner's resistance and assessing the patient's strength on a scale of 0 to 5.
|
Baseline and 8 weeks
|
Collaborators and Investigators
Investigators
- Study Director: Farhan I Khan, PhD, Dow University of Health Sciences
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
- 2777
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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