- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06947239
Additional Effects of Mirror Therapy on Shoulder Mobility and Function in Post-stroke Adhesive Capsulitis Patients
The estimated annual incidence of stroke in Pakistan is 250/100, 000. Upper limb impairments and post-stroke musculoskeletal complications such as pain, subluxation and restricted joint range of motion are commonly reported. Among many other shoulder impairments, adhesive capsulitis is a leading cause of limited mobility, reduced range of motion, and pain in stroke patients.
The aim of the current study will benefit the clinicians and physiotherapists as it provide an insight to treat post stroke adhesive capsulitis. Effects of mirror therapy have been established but the literature does not provide best treatment approaches or modalities for different types of Hemiplegic shoulder pain. This study will address the limitations in treatment approaches concerning the shoulder joint and its mobility in post-stroke adhesive capsulitis.
The study will be non-blinded randomized control trial, consisting of two groups. Study will be conducted over a period of 1 year. Subjects will be selected via non-probability purposive sampling technique using coin toss method followed by randomization into two groups (A and B).Ethical approval will be obtained from ERC FUMC.
One group will receive mirror therapy while other will receive conventional exercises treatment for period of 6 weeks. Baseline tests will be performed before and after the intervention of mirror therapy & outcome measure assessments will be done after every 3 weeks for a total period of 6 weeks intervention period. Data will be entered and analyzed on SPSS version 22.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES OF STUDY
- To determine the effects of mirror therapy along with conventional therapy on improving shoulder joint range of motion in post-stroke adhesive capsulitis patients.
- To determine the effects of mirror therapy along with conventional therapy on improving shoulder joint function in post-stroke adhesive capsulitis patients.
- To compare the difference between the effects of mirror therapy with conventional therapy alone for improving shoulder mobility and function in post stroke adhesive capsulitis patients.
HYPOTHESIS ALTERNATE HYPOTHESIS
- There is a statistically significant effect of mirror therapy in improving the shoulder joint Range Of Motion in post-stroke adhesive capsulitis patients. (p > 0.05).
- There is a statistically significant effect of mirror therapy in improving the shoulder joint function in post-stroke adhesive capsulitis patients. (p > 0.05).
NULL HYPOTHESIS
- There is a statistically significant effect of mirror therapy in improving the shoulder joint Range Of Motion in post-stroke adhesive capsulitis patients. (p > 0.05).
- There is a statistically significant effect of mirror therapy in improving the shoulder joint function in post-stroke adhesive capsulitis patients. (p > 0.05).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Islamabad, Pakistan, 44000
- Foundation University College of Physical Therapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both genders male and female
- Age 40-70 years
- Ability to understand and follow simple verbal instructions
- Patients able to stand for at least 10-15 mins.
- Ability to participate in a therapy session by coming to hospital.
- Chronic Stroke (ischemic) patients (6 months-1year) with adhesive capsulitis (capsular pattern :external rotation> abduction > internal rotation)
- Scores of >24 on Montreal Cognitive assessment scale.
Exclusion Criteria:
- Upper limb fractures or cervical spine pathology or radiculopathy
- History of upper limb surgery or trauma
- Rotator cuff pathology or prolonged immobilization of upper limb
- Rheumatic disease, fibromyalgia or any other musculoskeletal disorder that is altering upper extremity movement
- Any other neurological condition
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mirror therapy along with conventional therapy
It includes participants receiving mirror therapy session in adhesive capsulitis of post stroke patients for a period of 6 weeks. The experimental group will receive 20 minutes of conventional therapy followed by 20 minutes of mirror therapy training including 3 minutes of rest period between the interventions. |
The experimental group will receive 20 minutes of conventional therapy followed by 20 minutes of mirror therapy training including 3 minutes of rest period between the interventions. WEEK OF INTERVENTION: TASK PERFORM IN FRONT OF MIRROR: WEEK :1-2 ACTIVE SHOULDER ROM: flexion, abduction, external-internal rotation movements of the intact extremity Increase the number of repetition according to the patient progression WEEK:3-4 ACTIVITIES TARGETING SHOULDER ROM: Cleaning the mirror with a towel(internal rotation+ abduction) Lifting a glass to drink ( flexion + abduction) Holding a brush to comb hair (external rotation WEEK:5-6 Overhead reaching (pasting stickers on the mirror)(internal rotation / abduction) Lifting a bottle overhead. ( flexion/abduction) Throwing a ball (external rotation) PROGRESSION OF TASK SPECIFIC MIRROR THERAPY: WEEK: 1-2 Increase the number of repetition according to the patient progression WEEK:3-4 Add water in glass Transfer glass |
|
Active Comparator: Conventional Therapy
it includes 11 participants receiving conventional physical therapy for a period of 6 weeks. The control group will receive the conventional therapy for 40 minutes including:
|
Details: Weeks wise: The control group will receive 20 mints of conventional therapy .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of motion
Time Frame: 6 weeks
|
Goniometer will be used to assess range of motion at the shoulder
|
6 weeks
|
|
cognitive impairment
Time Frame: 6 weeks
|
Montreal cognitive assessment test that was used to detect mild cognitive impairment
|
6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- FUI/CTR/2024/67
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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