| CTRI Number |
CTRI/2025/09/095508 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
27/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effects of scapular stabilization exercises on upper limb and hand function in stroke patients |
|
Scientific Title of Study
|
The effectiveness of scapular stabilization exercises on upper extremity and hand motor function in subacute stroke patients: A Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Burange |
| Designation |
Postgraduate student |
| Affiliation |
YMT College of Physiotherapy, kharghar |
| Address |
Dr. G. D. Pol Foundation, YMT College of Physiotherapy, Institutional Area, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra 410210
Raigarh
MAHARASHTRA
442001
India |
| Phone |
9834434004 |
| Fax |
|
| Email |
nehaburange2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharda Bhalerao |
| Designation |
Associate professor |
| Affiliation |
YMT College of Physiotherapy, kharghar |
| Address |
Dr. G. D. Pol Foundation, YMT College of Physiotherapy, Institutional Area, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9850059332 |
| Fax |
|
| Email |
bhalerosharda90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharda Bhalerao |
| Designation |
Associate professor |
| Affiliation |
YMT College of Physiotherapy, kharghar |
| Address |
Dr. G. D. Pol Foundation, YMT College of Physiotherapy, Institutional Area, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9850059332 |
| Fax |
|
| Email |
bhalerosharda90@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Neha Burange |
| Address |
Dr. G. D. Pol Foundation, YMT College of Physiotherapy, Institutional Area, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra 410210 |
| Type of Sponsor |
Other [Other (self)] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neha Burange PT |
YMT College of physiotherapy hospital, kharghar |
Dr. G. D. Pol Foundation YMT College of Physiotherapy Institutional Area Belpada Rd Sector 4 Kharghar Navi Mumbai Maharashtra 410210
Neuro physiotherapy department
Room no. 301
Raigarh
MAHARASHTRA |
9834434004
nehaburange2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| YMT COP Ethical institutional comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional therapy exercises |
It is a 4-week rehabilitation or exercise protocol 30 minutes per session, 5 days per week focusing on upper limb and lower limb functional training in different positions supine, sitting, standing.
Supine lying on back
Assisted arm elevation with circular motions progressing to independent lowering and lifting.
Shoulder movements abduction, vertical lifting.
Functional tasks touching head, opposite shoulder with therapist facilitating finger/thumb extension.
Elbow flexion,extension in forearm supination without shoulder involvement.
Pole exercises with elbows extended.
Core or leg strengthening bridging, hip flexion, extension, abduction.
Sitting
Protective extension training using therapist’s resistance.
Hand function grip and release with towel, walking hand upward.
Sit-to-stand practice.
Standing
Weight-bearing on extended arms.
Wall support with hand flat, lifting sound leg.
Bridging, hip strengthening in multiple planes.
Each exercise 5s second hold
Rest 30 seconds between sets
Volume 3 sets 15 reps
Schedule 30 minutes per session, 5 days per week, for 4 weeks |
| Intervention |
scapular stabilization exercises |
the effects of scapular stabilization exercises in subacute stroke patients in 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. First ever occurence of stroke 1 to 6 months
2.clinically pre diagnosed ischemic and hemorrhagic stroke
3. No severe cognitive impairment
4.Both left and right sided hemiplegia |
|
| ExclusionCriteria |
| Details |
1. Recent cervical injury
2. Hand deformity
3. Non-ambulatory patients
4. Visual Field deficits
5. Psychological problem
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
WFMT (Wolf motor function test)
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CAHAI (Chedoke arm and hand activity inventory) |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
09/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
09/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title
The effectiveness of scapular stabilization exercises on upper extremity and hand motor function in subacute stroke patients: A Randomized Controlled Trial
Background
-
Stroke is a leading cause of disability, with many survivors developing upper limb dysfunction.
-
Weakness of scapular stabilizers alters shoulder mechanics, reducing motor control and functional ability.
-
Early rehabilitation (within 6 months) is critical due to higher neuroplasticity.
Objective
To evaluate whether 4 weeks of scapular stabilization exercises improve upper extremity and hand motor function in subacute stroke patients.
Hypothesis
Methods
-
Design: Randomized controlled trial, double-blinded.
-
Sample size: 44 patients (22 per group).
-
Population: First-ever stroke, 1–6 months, age 40–80 years, no severe cognitive impairment.
-
Groups:
-
Experimental: Scapular stabilization + conventional physiotherapy.
-
Control: Conventional physiotherapy only.
-
Both: 30 minutes, 5 days/week, for 4 weeks.
-
Outcome measures:
-
Analysis: Normality check (Shapiro-Wilk). T-tests or non-parametric equivalents (Wilcoxon, Mann-Whitney) using SPSS.
Intervention Details
-
Experimental group: Scapular exercises (protraction/retraction, elevation/depression, rotation, wall push-ups).
-
Control group: Conventional arm/shoulder mobility and functional exercises (supine, sitting, standing).
Expected Outcomes
Significance
|