| CTRI Number |
CTRI/2025/04/084833 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| 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
|
Action Observation Therapy with Positive v/s Error Feedback on Dynamic Balance in Hemiparetic Stroke Patients |
|
Scientific Title of Study
|
Action Observation Therapy with Positive v/s Error Feedback on Dynamic Balance in Hemiparetic Stroke Patients: A Comparative 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 |
Sarika Shrivastav |
| Designation |
Postgraduate student |
| Affiliation |
Datta Meghe College of Physiotherapy Nagpur Nagpur |
| Address |
Department of Neurosciences Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
7977871456 |
| Fax |
|
| Email |
shrivastavsarika1522@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neha Chaudhary |
| Designation |
HOD Neuroscience Physiotherapy |
| Affiliation |
Datta Meghe College of Physiotherapy Nagpur Nagpur |
| Address |
Department of Neurosciences Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9975457653 |
| Fax |
|
| Email |
nehaneuro85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sarika Shrivastav |
| Designation |
Postgraduate student |
| Affiliation |
Datta Meghe College of Physiotherapy Nagpur Nagpur |
| Address |
Department of Neurosciences Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
7977871456 |
| Fax |
|
| Email |
shrivastavsarika1522@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe College of Physiotherapy, Wanadongri, Hingna Road, Nagpur 441110, MAHARASHTRA, INDIA |
|
|
Primary Sponsor
|
| Name |
Datta Meghe College of Physiotherapy |
| Address |
Shri Datta Meghe Polytechnic Campus, Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sarika Shrivastav |
Outpatient Department of Neuroscience Physiotherapy, Datta Meghe College of Physiotherapy |
Department of Neurosciences Physiotherapy, Datta Meghe College of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 India
Nagpur
MAHARASHTRA |
07977871456
shrivastavsarika1522@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Ayurved, Physiotherapy, Nursing (APN) Colleges Institutional Ethical Committee |
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 |
Action Observation Therapy with Error Feedback |
The patients will undergo 3 minutes of action observation therapy (1.5 minutes for observing Low and High Functioning tasks) in which they will watch their video of performing the tasks with 12 minutes of task execution. These low and high functioning task includes exercises on bobo balance board in sitting and standing position with weight shifting in medial and lateral direction and forward backward direction with 30 minutes of conventional physiotherapy that includes strengthening, stretching, and gait training will be given to the patients
|
| Intervention |
Action Observation Therapy with Positive Feedback |
The patients will undergo 3 minutes of action observation therapy(1.5 minutes of observing Low and High Functioning tasks ) in which they will observe normal individuals performing the tasks with 12 minutes of task execution. These low and high functioning task includes exercises on bobo balance board in sitting and standing position with weight shifting to medial and lateral direction and forward backward direction with 30 minutes of conventional physiotherapy that includes strengthening, stretching and gait training will be given to the patients
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subacute Hemiparetic Stroke Patients
Modified Ashworth Scale More Than Grade 1 for lower limb
Berg Balance Score More than 20
Voluntary Control Grading 4 onwards
Ability to encode observed human actions
No Visual Field Defect |
|
| ExclusionCriteria |
| Details |
Mini Mental Status Examination Score Less Than 23
Pushers Syndrome
Unilateral Neglect
Postural Hypotension
Impaired Comprehension
Presence of Visual Auditory or Tactile Impairment |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Activity specific Balance Confidence Scale
Bobo Balance Board |
1 Baseline week 0
2 After Week 1
3 After week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
30/04/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Consent will be taken and participants will be informed about the study purpose objectives and methodology Participants who satisfy the selection criteria will be recruited for the study Baseline assessments and general evaluation for all the participants will be conducted Participants are randomly assigned to either the positive feedback or error feedback group. Introduce and familiarize participants with the Bobo Balance Board Use the Bobo balance board to perform baseline balance assessments The intervention for AOTPF and AOTEF groups will be given for 45 minutes for 5 days for 1 week Post assessment will be taken after 1 week and after 1 month All the participants will be randomly divided into two groups Group AOTPF and Group AOTEF will undergo action observation therapy for 3 minutes with 12 minutes of task execution on bobo balance board Data analysis will be done |