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CTRI Number  CTRI/2024/01/061784 [Registered on: 24/01/2024] Trial Registered Prospectively
Last Modified On: 19/01/2024
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   Task- Oriented Arm Training in Chronic Stroke Patients 
Scientific Title of Study   Effectiveness of Task- Oriented Bilateral Arm Training with Rhythmic Auditory Cueing for Upper Limb Activities in Chronic Stroke. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Cheitali Kochhar 
Designation  PG Student 
Affiliation  Amity Institute of Health Allied Sciences 
Address  Amity Institute of Health Allied Sciences, Lower Ground Floor, Room no.- LG-11 Amity University Uttar Pradesh Noida
India Physio Clinic, Ground Floor, Room no.-1, E-72, Sector- 36, Greater Noida- 201310
Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  8376042041  
Fax    
Email  cheitalikochhar.ck@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Neha Gupta 
Designation  Associate Professor 
Affiliation  Amity Institute of Health Allied Sciences 
Address  Amity Institute of Health Allied Sciences, F1 Block, First Floor, Faculty Room, Amity University Uttar Pradesh, Noida

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9810280418  
Fax    
Email  ngupta4@amity.edu  
 
Details of Contact Person
Public Query  
Name  Cheitali Kochhar 
Designation  PG Student 
Affiliation  Amity Institute of Health Allied Sciences 
Address  Amity Institute of Health Allied Sciences, F1 Block, Lower Ground Floor, Room no.- LG-11, Amity University Uttar Pradesh Noida
India Physio Clinic, Ground Floor, Room no.-1, E-72, Sector- 36, Greater Noida- 201310
Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  8376042041  
Fax    
Email  cheitalikochhar.ck@gmail.com  
 
Source of Monetary or Material Support  
India Physio Clinic E-72, Sector- 36, Greater Noida- 201310 
 
Primary Sponsor  
Name  Cheitali Kochhar 
Address  Amity Institute of Health Allied Sciences, Lower Ground Floor, Room no.- LG-11 Amity University Uttar Pradesh Noida 
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 Kapil Chaudhary  India Physio Clinic  India Physio Clinic, Ground Floor, Room no.-1, E-72 Sector- 36 Greater Noida- 201310
Gautam Buddha Nagar
UTTAR PRADESH 		 8586835603

kapilchawda0050@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
India Physio Clinic  No Objection Certificate 
Institutional NTCC Committee Amity Institute of Health Allied Sciences, Amity University Uttar Pradesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G811||Spastic hemiplegia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bilateral Arm Training with Rhythmic Auditory Cueing   This group of participants will be given only bilateral arm exercises with Rhythmic Auditory Cueing through a metronome. It will be a 1 hour session 3 days a week for 6 weeks, making it a 18 hour protocol. 
Intervention  Task- Oriented Bilateral Arm Training with Rhythmic Auditory Cueing   This group of participants will be given Task- Oriented Training with bilateral arm training with Rhythmic Auditory Cueing. It will be a 1 hour session 3 days a week for 6 weeks, making it a 18 hour protocol. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Unilateral Stroke 6 months or more
2. 18 years to 80 years
3. Arm weak but able to move 3 inches beyond neutral
4. FMA score ≥ 30 and ≤ 45
5. MoCA score > 22
6. Participant able to spare 1.5 hr, 3 days a week.
7. Participant able to sit on chair with back supported for 1 hour period comfortably.
 
 
ExclusionCriteria 
Details  1. Arm weakness due to other comorbidities along with stroke.
2. Any orthopaedic conditions of upper limb.
3. Symptomatic heart disease and uncontrolled hypertension (>180/100 mmHg).
4. Presence of contractures
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Motor Function- measured by Fugl- Meyer Assessment Upper Extremity (FMA-UE)
2. Upper Extremity Performance- measured by Wolf Motor Function Test (WMF) 		 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Functional Ability of Affected Arm- measured by Chedoke Arm and Hand Activity Inventory (CAHAI)  6 weeks 
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
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)   31/01/2024 
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="0"
Months="1"
Days="15" 
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   This study is a randomized, single- blinded, parallel group, single- centred trial, aims to compare the effectiveness of BATRAC and BATRAC-TOT in improving motor function, upper extremity performance and functional ability of affected arm in chronic stroke patients meausred by FMA-UE, WMF and CAHAI, respectively. BATRAC involves Bilateral Arm Training i.e. performing of identical activities with both arms at the same time so that the non- affected arm can facilitate activation of affected hemisphere through interhemispheric connections and thus influence performance of affected arm and the Rhythmic Auditory Cueing is the use of repetitive auditory stimuli in the form of a metronome to which participants are asked to perform exercises. TOT involves bilateral arm training with specific tasks in order to improve ability to perfom day to day activities independently.




 
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