| CTRI Number |
CTRI/2025/07/090370 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| 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
|
Intervention of Home-Based Video-Assisted Exercises for improving upper limb in Stroke Participances |
|
Scientific Title of Study
|
Efficacy of Home-Based Action Observation Therapy on upper limb functional development in chronic 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 |
Soumik Saha |
| Designation |
Masters of physiotherapy |
| Affiliation |
Nopany Institute of Healthcare studies |
| Address |
Nopany Physiotherapy Clinic, physiotherapy department
Nopany Physiotherapy Clinic, physiotherapy department
Kolkata
WEST BENGAL
700006
India |
| Phone |
8240137205 |
| Fax |
|
| Email |
soumik1998saha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anwesh Pradhan |
| Designation |
Associate professor |
| Affiliation |
Nopany Institute of Healthcare studies |
| Address |
Nopany Physiotherapy Clinic, physiotherapy department
Kolkata
WEST BENGAL
700006
India |
| Phone |
8240137205 |
| Fax |
|
| Email |
anwesh@nihs.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Mainak Patra |
| Designation |
Assistant Professor |
| Affiliation |
Nopany Institute of Healthcare studies |
| Address |
Nopany Physiotherapy Clinic, physiotherapy department
Kolkata
WEST BENGAL
700006
India |
| Phone |
8240137205 |
| Fax |
|
| Email |
mainak@nihs.ac.in |
|
|
Source of Monetary or Material Support
|
| Nopany institute of Healthcare studies, kolkata , west bengal, Indian, pin-700006 |
|
|
Primary Sponsor
|
| Name |
Nopany Institute of Healthcare Studies |
| Address |
Nopany Institute of Healthcare Studies, kolkata, West Bengal, India, Pin-700006 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Soumik saha |
Nopany Physiotherapy Clinic |
2C, Nanda Mullick Lane, Nutan Bazar, Girish Park, Jorasanko, Kolkata, West Bengal 700006
Physiotherapy department
Kolkata
WEST BENGAL |
8240137205
soumik1998saha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nopany Institute of Healthcare Studies Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Action observation Therapy |
Action Observation Therapy is a new form of rehabilitation where the patient is required to observe a video clip of exercises that the therapist provides. After watching for some time, the patient is asked to perform the observed task to the best of his/her ability. The purpose of action observation treatment is to stimulate functional reorganization within the brain of stroke patients by activating these mirror neurons, to facilitate motor function recovery and cognition development. Action Observation increases motor learning in healthy individuals and is a potential approach to restoring motor function after stroke. In AOT the self-directed videos improve motor recovery based on the new motor skills. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Chronic stroke patients(after 6 months)
2. Brunnstrom recovery stages of upper extremity score greater than or equal to 4
3. Mini-Mental State Examination scale score greater than or equal to 24
4. First episode of unilateral stroke
5. Age 40 to 65 years
6. Both genders
7. Availability of any displayed electric gadgets in which video of exercise can be played
|
|
| ExclusionCriteria |
| Details |
1. Loss of vision
2. Patients with tightness, contracture, deformity of the upper limb |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Upper limb function
|
4 Weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cognition |
4 Weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Upper limb function and cognition deficits are very common after a stroke. More than 50% of stroke survivors suffer from impaired motor function in the upper extremity and impaired cognitive performance. various approaches are implemented to improve upper limb function and cognitive performance. Action Observation Therapy (AOT) is one of the newest approaches currently used by physiotherapists when prescribing for motor function. Home-based exercise rehabilitation has delivered some exercises at home which benefit stroke survivors. Home-based Action Observation Therapy where the patient is required to observe a video clip of exercises which is provided by the therapist. After watching for some time, the patient is asked to perform the observed task to the best of his/her ability. Purpose of the study: The purpose of the study is to find out the effect of Home-based Action Observation Therapy versus conventional home-based programs on upper limb functional development and cognitive development in stroke patients. Methodology: The patient will be selected based on inclusion and exclusion criteria. Group A will perform Home-based Action Observation Therapy and Group B perform conventional home-based programs for 6 days per week for 4 weeks. Statistical Analysis: The statistical analysis will be conducted using SPSS software version 25. The primary analysis will use descriptive statistics to analyze the demographic data. Pre(based line) and post(after 4 weeks) intervention data will be collected. students t-tests will be used for the inter-group and within-group data analysis. The level of significance will be considered upon p value= 0.05.
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