| CTRI Number |
CTRI/2025/06/088783 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Action Observation vs Standard Therapy for Bed Mobility and Trunk Control After Stroke |
|
Scientific Title of Study
|
Effect of Action Observation Training (AOT) Versus Conventional Therapy on Bed Mobility and Trunk Control in Patients with Acute Stroke: A Randomized Control 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 |
HRUSHIKESH ASHOK MANGAVE |
| Designation |
PG Student |
| Affiliation |
DVVPFs College of Physiothetapy |
| Address |
Department of Neurophysiotherapy,DVVPFs College of Physiotherapy,Vilat Ghat ,Ahmednagar,Pimpalgaon Malvi,Maharashtra 414111.
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
7776986383 |
| Fax |
|
| Email |
hrushi012000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suvarna Ganvir |
| Designation |
Head of Department of Neurophysiotherapy |
| Affiliation |
DVVPFs College of Physiotherapy |
| Address |
Department of Neurophysiotherapy,DVVPFs College of Physiotherapy,Vilat Ghat ,Ahmednagar,Pimpalgaon Malvi,Maharashtra 414111.
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9372910683 |
| Fax |
|
| Email |
suvarna.ganvir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suvarna Ganvir |
| Designation |
Head of Department of Neurophysiotherapy |
| Affiliation |
DVVPFs College of Physiotherapy |
| Address |
Department of Neurophysiotherapy,DVVPFs College of Physiotherapy,Vilat Ghat ,Ahmednagar,Pimpalgaon Malvi,Maharashtra 414111.
MAHARASHTRA
414111
India |
| Phone |
9372910683 |
| Fax |
|
| Email |
suvarna.ganvir@gmail.com |
|
|
Source of Monetary or Material Support
|
| DVVPFs College of Physiotherapy, Opp.Govt.milk Dairy,M.I.D.C.,Ahmednagar 414 111. |
|
|
Primary Sponsor
|
| Name |
DVVPFs College of Physiotherapy |
| Address |
DVVPFs College of Physiotherapy, Opp.Govt.milk Dairy,M.I.D.C.,Ahmednagar 414 111. |
| 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 Hrushikesh Ashok Mangave |
DVVPFs College of Physiotherapy |
Dept. of Neurophysiotherapy,DVVPFs College of Physiotherapy, Opposite Govt Milk Dairy,MIDC, Ahmednagar
Ahmadnagar
MAHARASHTRA |
7776986383
hrushi012000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DVVPFs college of Physiotherapy |
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 |
| Intervention |
Action Observation Therapy |
To improve Bed Mobility and Trunk Control. For 30 min and 7 consecutive days |
| Comparator Agent |
Conventional Therapy |
To improve Bed Mobility and Trunk control. For 30 min and 7 consecutive days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Acute Stroke.
Glasgow Coma Scale GCS Score 13 to 15.
Patients willing to participate. Patients with first onset Stroke.
|
|
| ExclusionCriteria |
| Details |
Patients with impaired vision and hearing problem.
Patients with any kind of fracture.
Patients with Musculoskeletal and cardiovascular conditions.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postural Assessment Scale for Stroke Patients (PASS) |
Baseline, 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Trunk Impairment Scale (TIS):- |
Baseline, 1 week |
| Stroke Rehabilitation Assessment of movement (STREAM) |
Baseline, 1 week |
| ICF Codes |
Baseline, 1 week |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
01/07/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study compares the effect of Action observation therapy with conventional therapy in patients with acute stroke within one week of intervention to improve bed mobility and trunk control. In order to measure bed mobility, Postural Assessment Scale for Stroke Patients will be used. To measure the transition from supine to sitting position, the Stroke Rehabilitation Assessment of Movement scale would be documented. To evaluate trunk control, Trunk Impairment Scale will be used. ICF Codes for evaluation of changing and maintaining body position will be taken. All the above mentioned outcomes would be documented as baseline and after one week of intervention. The subjects will be randomly divided into two groups, the first group will be given Action Observation Training as an intervention whereas the second group would be given Conventional Therapy. After obtaining the data, it will be analyzed using statistical tests. |