| CTRI Number |
CTRI/2026/03/106405 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Study to find which physiotherapy method is better for improving arm use and daily activities after stroke |
|
Scientific Title of Study
|
Effectiveness of Action Observation Treatment versus Modified Constraint Induced Movement Therapy on Improving Upper Limb Function in Subacute Stroke Patients: A Quasi-Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GUDITI SHRUTI |
| Designation |
Postgraduate Student MPT |
| Affiliation |
MALLA REDDY UNIVERSITY |
| Address |
Room No. 4305, Department of Physiotherapy, School of Allied Health Sciences, Malla Reddy University, Maisammaguda, Bhadurpalle, Hyderabad, Telangana – 500100, India.
Hyderabad
TELANGANA
500100
India |
| Phone |
8106911579 |
| Fax |
|
| Email |
2421PT010045@mallareddyuniversity.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
GUDITI SHRUTI |
| Designation |
Postgraduate Student MPT |
| Affiliation |
MALLA REDDY UNIVERSITY |
| Address |
Room No. 4305, Department of Physiotherapy, School of Allied Health Sciences, Malla Reddy University, Maisammaguda, Bhadurpalle, Hyderabad, Telangana – 500100, India.
Hyderabad
TELANGANA
500100
India |
| Phone |
8106911579 |
| Fax |
|
| Email |
2421PT010045@mallareddyuniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
GUDITI SHRUTI |
| Designation |
Postgraduate Student MPT |
| Affiliation |
MALLA REDDY UNIVERSITY |
| Address |
Room No. 4305, Department of Physiotherapy, School of Allied Health Sciences, Malla Reddy University, Maisammaguda, Bhadurpalle, Hyderabad, Telangana – 500100, India.
Hyderabad
TELANGANA
500100
India |
| Phone |
8106911579 |
| Fax |
|
| Email |
2421PT010045@mallareddyuniversity.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Malla Reddy College of Physiotherapy (SOAHS) |
| Address |
Department Of Physiotherapy, SOAHS, Maisammaguda, Bhadurpalle, Hyderabad, Telangana 500100 |
| Type of Sponsor |
Private medical college |
|
|
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 Chandrika Adi PT |
MALLA REDDY HOSPITAL |
Department of General Medicine Male and Female Medicine IP Wards,
Male Medicine IP Rooms No. 2301, 4302
Female Medicine IP Rooms No. 101, 102,
Malla Reddy Hospital, Venkatarama Colony, Suraram,Hyderabad, Telangana – 500055, India
Hyderabad
TELANGANA |
8688387639
adi.chandrika@mallareddyuniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Malla Reddy Institute Of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Action Observation Treatment |
Participants observe videos demonstrating task-oriented upper limb activities and subsequently perform the observed movements under therapist supervision. The intervention focuses on improving motor learning and upper limb function in subacute stroke patients for 5 days per week for 4 weeks, Total duration is One month |
| Comparator Agent |
Modified Constraint Induced Movement Therapy |
Participants undergo modified constraint induced movement therapy where the unaffected upper limb is restrained for a specified period while performing repetitive task-oriented training using the affected upper limb to improve motor function for 5 days per week for 4 weeks, Total duration is One month |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with a confirmed diagnosis of subacute stroke 1 week to 6 months
2 Both Sexes and age between 30 to 80 years
3 Brunnstorm Stage 2 to 5 for the affected upper limb
4 Spasticity should be smaller than or equal to grade 3 in Modified Ashworth Scale
5 Patients should be able to understand and follow simple commands and no severe cognitive imairement Mini mental state Examination score more than or equal to 24
Hearing and visual acuity 20 by 20 to 20 by 80 that is normal to mild impairement with aids |
|
| ExclusionCriteria |
| Details |
1 Completely Flaccid Upper limb with no voluntary movements Fugl Meyer Assessment Upper Extremity less than or equal to 20
2 Patients with recurrent strokes leading to bilateral limb involvement
3 Dementia Severe Depression or other neurological disorders affecting motor learning
4 severe neglect Visual field Deficits or inability to observe movements properly
5 Uncontrolled Cardiovascular diseases or Orthopedic conditions or other systemic illnesses limiting participation
6 Patients who have undergone intensive rehabilitation programs within the last 3 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulg Meyer Assessment-Upper Extremity |
Baseline (0 week),Post- Intervention (4 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional Independence Measure |
Baseline (0 week)
Post- Intervention (4 weeks) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/03/2026 |
| Date of Study Completion (India) |
30/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Participants included in this study are individuals diagnosed with subacute stroke presenting with unilateral upper limb motor impairment At baseline demographic characteristics such as age and gender will be recorded Clinical characteristics including duration of stroke and level of motor impairment and baseline upper limb functional status will be assessed using standardized outcome measures before the initiation of interventions |