NCT06947239

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

April 21, 2025

Last Update Submit

April 21, 2025

Conditions

Keywords

post stroke patientsRange of motion correctionmirror therapy exercises

Outcome Measures

Primary Outcomes (2)

  • Range of motion

    Goniometer will be used to assess range of motion at the shoulder

    6 weeks

  • cognitive impairment

    Montreal cognitive assessment test that was used to detect mild cognitive impairment

    6 weeks

Study Arms (2)

Mirror therapy along with conventional therapy

EXPERIMENTAL

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

Conventional Therapy

ACTIVE COMPARATOR

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

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

Mirror therapy along with conventional therapy
Control GroupPROCEDURE

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

Conventional Therapy

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Bursitis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2025

First Posted

April 27, 2025

Study Start

June 20, 2024

Primary Completion

December 20, 2024

Study Completion

January 20, 2025

Last Updated

April 27, 2025

Record last verified: 2025-04

Locations