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Effectiveness of Physical Therapy in Stem Cell Transplant Recipients for Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis, Osteo Arthritis Knee, OA Knee

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Forward Walking
Physiotherapy Exercises
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis, Mesenchymal stem cell treatment, Physiotherapy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dow Institute of Physical Medicine and Rehabilitation, DUHS.Recruiting
  • Alkhaleej Ortho Stem Cell ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Forward Walking

Physiotherapy

Arm Description

This study ARM will receive following treatment in home program after mesenchymal stem cell treatment. • Forward Walking

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

Outcomes

Primary Outcome Measures

Knee Injury and Osteoarthritis Outcome Score (change is being assessed)
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.

Secondary Outcome Measures

Visual analog scale (change is being assessed)
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
Manual Muscle Testing (change is being assessed)
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.

Full Information

First Posted
July 16, 2023
Last Updated
July 24, 2023
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05959902
Brief Title
Effectiveness of Physical Therapy in Stem Cell Transplant Recipients for Knee Osteoarthritis
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
November 6, 2023 (Anticipated)
Study Completion Date
December 6, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Knee osteoarthritis has been considered as 11th highest contributor factor to nonfatal burdens in the world. It is considered one of the most common degenerative diseases of synovial joint and major cause of muscle impairment with limited functional activities. Recent efforts to investigate the possibility of stem cell therapies in the treatment of symptomatic osteoarthritis have seen an increase in interest in regenerative medicine, fueled a better understanding of the role of mesenchymal stem cells. Knee osteoarthritis is mostly managed by physical therapy, focused on managing pain, increasing the restricted range of motion and muscle strengthening. Therefore, the hypothesis is that combining both treatments will be beneficial for patients. The aim of this randomized controlled trial is to evaluate the effectiveness of physiotherapy in mesenchymal stem cell recipient in improving pain, quadriceps muscle strength and functional status of knee osteoarthritis patients.
Detailed Description
A single blinded RCT will be conducted at Ortho Stem Cell Department, AlKhaleej Clinics. Collection of data will be started after the scientific and ethical approval from Dow University, Karachi. After screening by physician and fulfilling the inclusion and exclusion criteria, patients (n=48) will be enrolled. After briefing about the objectives and obtaining formal consent, data will be collected. Participants will be randomized and equally distributed into two groups i.e., twenty-four in control group '1' and twenty-four in treatment group '2'. The control group '1' will receive forward walking in home program after mesenchymal stem cell treatment while the treatment group '2' will be receiving quadriceps isometric exercise, straight limb raises (SLR), hip isometric adductor, knee terminal extension, semi wall squat, quadriceps drill exercises for knee osteoarthritis after mesenchymal stem cell therapy. Treatment plan will be of 8 weeks with 3 sessions in one week for 30 minutes. A physical therapist will do the assessment at baseline and at the end of treatment, other than the principal investigator to measure outcomes by using KOOS score, manual muscle testing and VAS scale. For the completion of the study 6 months are required after synopsis approval.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Osteo Arthritis Knee, OA Knee
Keywords
Knee osteoarthritis, Mesenchymal stem cell treatment, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Forward Walking
Arm Type
Active Comparator
Arm Description
This study ARM will receive following treatment in home program after mesenchymal stem cell treatment. • Forward Walking
Arm Title
Physiotherapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Forward Walking
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physiotherapy Exercises
Intervention Description
Isometric quadriceps exercise. Straight leg raising (SLR) exercise. Isometric hip adduction exercise. Terminal knee extension exercise: Semi-wall squat exercise. Quadriceps drill exercise.
Primary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score (change is being assessed)
Description
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.
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Visual analog scale (change is being assessed)
Description
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
Time Frame
Baseline and 8 weeks
Title
Manual Muscle Testing (change is being assessed)
Description
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.
Time Frame
Baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Syed Muhammad Zaeem Hasan Zaidi, DPT
Phone
03320319277
Email
hxaeem@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Farhan I Khan, PhD
Phone
03332209704
Email
farhan.ishaque@duhs.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farhan I Khan, PhD
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Dow Institute of Physical Medicine and Rehabilitation, DUHS.
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Syed Muhammad Zaeem Hasan Zaidi, DPT
Phone
03320319277
Email
hxaeem@gmail.com
Facility Name
Alkhaleej Ortho Stem Cell Clinic
City
Karachi
State/Province
Sindh
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Syed Muhammad Zaeem Hasan Zaidi, DPT
Phone
03320319277
Email
hxaeem@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Physical Therapy in Stem Cell Transplant Recipients for Knee Osteoarthritis

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