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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-06

Study Completion Date

2023-12-06

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Knee Osteoarthritis Osteo Arthritis Knee OA Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Forward Walking

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

• Forward Walking

Group Type ACTIVE_COMPARATOR

Forward Walking

Intervention Type OTHER

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.

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

Group Type EXPERIMENTAL

Physiotherapy Exercises

Intervention Type OTHER

Isometric quadriceps exercise. Straight leg raising (SLR) exercise. Isometric hip adduction exercise.

Terminal knee extension exercise:

Semi-wall squat exercise. Quadriceps drill exercise.

Interventions

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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.

Intervention Type OTHER

Physiotherapy Exercises

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

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No