| CTRI Number |
CTRI/2025/09/094180 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Exercises for Shoulder pain after Stroke |
|
Scientific Title of Study
|
Efficacy of Scapular Stabilization Exercise on Shoulder Hand
Syndrome among Post-Stroke Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sayda Sadia Tuj Jahra |
| Designation |
Student |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no: 304, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Bangladesh
7408 Other |
| Phone |
8801877122109 |
| Fax |
|
| Email |
sadiatazneen213@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ehsanur Rahman |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no: 401, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Bangladesh
7408 Other |
| Phone |
8801716062263 |
| Fax |
|
| Email |
e.rahman@just.edu.bd |
|
Details of Contact Person Public Query
|
| Name |
Dr Ehsanur Rahman |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no: 401, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Bangladesh
7408 Other |
| Phone |
8801716062263 |
| Fax |
|
| Email |
e.rahman@just.edu.bd |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
|
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy and Rehabilitation |
| Address |
Room: 401, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408, Bangladesh |
| Type of Sponsor |
Other [University] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Farzana Sharmin Rumana |
Centre for the Rehabilitation of the Paralysed (CRP) |
Neurology Unit, Centre for the Rehabilitation of the Paralysed, Savar, Bangladesh
|
8801614118881
rumanaphysio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB of Department of Physiotherapy and Rehabilitation, JUST |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I638||Other cerebral infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No comparator as it is a single group pre-test post-test design |
It is a single group pre-test post-test design |
| Intervention |
Scapular Stabilization Exercise |
Participants will receive scapular stabilization exercises 3 times per week for 4 weeks, delivered through supervised physiotherapy sessions aimed at reducing shoulder-hand syndrome symptoms |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Confirmed diagnosis of a first-ever stroke supported by a head CT or MRI scan
2. first-onset stroke patients with unilateral hemiparesis.
3. 2 months to 6 months after stroke onset
4. Brunnstrom recovery stage four or above for the affected upper limb.
5. Impaired upper extremity fluid return, and vasomotor dysfunction following central nervous system injury
6. Attend voluntarily for this study with a signed informed consent.
7. Well general condition with stabilized vital signs and normal consciousness.
|
|
| ExclusionCriteria |
| Details |
1. Reversible stroke.
2. Hemorrhagic stroke
3. Spasticity in the upper limb
4. Severe visceral organ (e.g., heart, lung, liver, and kidney) dysfunction
5. Severe diagnosed cognitive dysfunction
6. History of diagnosed mental disease and could not cooperate in rehabilitation treatment
7. Implanted with cardiac pacemaker with upper limb dysfunction due to other causes
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Constant Murley Score will be used to assess shoulder function through pain intensity, activities of daily living, range of motion, and muscle strength |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pain intensity measured by Pressure Pain Threshold (PPT)
2. Spasticity will be measured by Modified Ashworth Scale (MAS)
3.Pain level and extent of difficulty with Activity of Daily Livings will be assessed by Shoulder Pain and Disability Index (SPADI) |
4 Weeks |
|
|
Target Sample Size
|
Total Sample Size="33" Sample Size from India="33"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [e.rahman@just.edu.bd].
- For how long will this data be available start date provided 01-02-2026 and end date provided 01-02-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a single-group, pre-test post-test study aimed at evaluating the efficacy of scapular stabilization exercises in the management of shoulder-hand syndrome (SHS) among post-stroke patients. The intervention is intended to enhance shoulder function by addressing pain, muscle tone, range of motion, and upper limb mobility. Primary and secondary outcomes will be measured using the Scapular Pain and Disability Index (SPADI), Constant-Murley Score (CMS), Modified Ashworth Scale (MAS), and Pressure Pain Threshold (PPT). The study will be conducted at the Neurology Unit of the Centre for the Rehabilitation of the Paralyzed (CRP), Savar, Bangladesh. |