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CTRI Number  CTRI/2024/06/069132 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 13/06/2024
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   The impact of Action Observation Training and Auditory Stimulation on Balance and Function Stroke Patients: An Experimental study 
Scientific Title of Study   Effect of the Combination of Action Observation Training and Rhythmic Auditory Stimulation on Balance and Functional Recovery of Sub-acute 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  Vismaya Thali  
Designation  1st year Masters of Physiotherapy in Neurosciences  
Affiliation  Goa Medical College and Hospital  
Address  Goa Medical College and Hospital, Department of Orthopaedic surgery, Bambolim - Goa, Pincode - 403202

North Goa
GOA
403202
India 
Phone  9421918693  
Fax    
Email  vismayathali2015@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vismaya Thali  
Designation  1st year Masters of Physiotherapy in Neurosciences  
Affiliation  Goa Medical College and Hospital  
Address  Goa Medical College and Hospital, Department of Orthopaedic surgery, Bambolim - Goa, Pincode - 403202

North Goa
GOA
403202
India 
Phone  9421918693  
Fax    
Email  vismayathali2015@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sachin Gawande  
Designation  Assistant Professor in Physiotherapy  
Affiliation  Goa Medical College and Hospital  
Address  Goa Medical College and Hospital, Department of Orthopaedic surgery, Bambolim - Goa, 403202

North Goa
GOA
403202
India 
Phone  77091199974  
Fax    
Email  dr.sachingawande.physio@gmail.com  
 
Source of Monetary or Material Support  
Vismaya Thali, Goa Medical College and hospital, Bambolim Goa  
 
Primary Sponsor  
Name  Vismaya Thali 
Address  Goa Medical College and Hospital,Bambolim-Goa, 403202 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sachin Gawande   Goa Medical College and Hospital   Department of Orthopedic surgery, Bambolim-Goa
North Goa
GOA 		 77091199974

dr.sachingawandephysio@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Goa Medical College Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Combination of Action Observation Training and Rhythmic Auditory Stimulation   Action Observation Training will be given for 5 minutes, where the participants will be given a video to watch on a smartphone, consisting of the same exercises that the patient has to perform, followed by the Balance retraining exercise program (Otago exercise program) along with Rhythmic Auditory Stimulation which will be applied through the use of the Metronome app (Metronome beats) on a smartphone. Participants will be instructed to match their steps with the beat of the metronome through careful listening during balance retraining and the tempo of the metronome will be individually customized before the intervention by studying the walking cadence per minute of each participant at their comfortable speed. Once the participant is able to perform the exercises with confidence, the exercises can be progressed every week by gradually increasing the tempo of the metronome. 
Comparator Agent  Conventional Physical therapy  It will include neuro-developmental therapy, balance training, aimed at improving balance and walking ability. One session of 30 minutes each, three times per week for a period of 5 weeks will be provided. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Participants from Goa Medical College and Hospital.
Sub- acute stroke patients whose time after onset was atmost 6 months after the diagnosis of stroke.
Participants with unilateral post- stroke hemiparesis.
Participants with FAC score: 1 to 4.
Participants with no cognitive impairment (MMSE score ≥ 24).
Participants who are willing to sign the informed consent.
 
 
ExclusionCriteria 
Details  Participants with history of recent surgery or trauma.
Participants with a positive history of neoplasms.
Participants with unstable medical conditions ( like cardiac failure, unstable angina,
uncontrolled hypertension)
Participants with clinically significant orthopaedic or musculoskeletal conditions affecting gait performance.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Tinetti Performance Oriented Mobility Assessment Scale and Functional Reach Test  At baseline and after 5 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Activities Specific Balance Confidence Scale  5 mins 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 1/ Phase 2 
Date of First Enrollment (India)   25/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/06/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="5"
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   Stroke is a serious global health issue and it is currently the fifth greatest cause of disability and the fourth major cause of death in India. Goa is recording a rise in the number of stroke cases. Following a stroke, alignment, stability, symmetry, and dynamic balance are all impaired, causing postural control and balance problems. The gait and dynamic balance abilities of stroke patients are extremely important because of their close relation with daily activities. Rhythmic Auditory Stimulation (RAS) is a typical therapeutic approach which uses auditory rhythmic cues in the form of beats of a metronome to promote auditory-motor entrainment of rhythmic movements. The beats are provided by using metronome apps on smartphone which are often freely available or at a relatively low cost, making it a cost-effective solution, thereby making this approach more efficient and feasible. Another effective technique that can be incorporated into the rehabilitation program is the Action Observation Training (AOT) which involves observing actions and constantly imitating and practicing them. Therefore, this study aimed to evaluate the effects of the combination of RAS and AOT on balance and functional recovery of subacute stroke patients and to assess the changes in the levels of self-confidence to perform activities without losing balance in patients with subacute stroke. 
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