Additional Effects of Mirror Therapy on Shoulder Mobility and Function in Post-stroke Adhesive Capsulitis Patients

April 21, 2025 updated by: Foundation University Islamabad

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

OBJECTIVES OF STUDY

  1. To determine the effects of mirror therapy along with conventional therapy on improving shoulder joint range of motion in post-stroke adhesive capsulitis patients.
  2. To determine the effects of mirror therapy along with conventional therapy on improving shoulder joint function in post-stroke adhesive capsulitis patients.
  3. 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

  1. 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).
  2. 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

  1. 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).
  2. 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Islamabad, Pakistan, 44000
        • Foundation University College of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: Mirror therapy along with conventional therapy

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:

  1. Heat pack & TENS to alleviate pain for 15 minutes
  2. Shoulder isometric exercises 10 reps
Procedure: Control Group

Details: Weeks wise:

The control group will receive 20 mints of conventional therapy .

  1. Heat pack & TENS to alleviate pain for 15 minutes
  2. Shoulder isometric exercises 10 reps
  3. Active and passive Range of Motion exercises 10 reps each
  4. Codman exercises 10 reps each
  5. Wand exercises 10 reps each

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Foundation University Islamabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FUI/CTR/2024/67

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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