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CTRI Number  CTRI/2025/07/091390 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 18/07/2025
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   Role of Technology-Supported Trunk Training on Balance in Stroke Survivors 
Scientific Title of Study   Effect of Technology-Based Trunk Training versus Conventional Therapy on the Rate of Recovery of Trunk in Individuals with Acute Stroke – A Pilot RCT 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhipsha Majumder 
Designation  Post Graduate Student 
Affiliation  Manipal College of Health Proessions, Manipal Academy of Higher Education, Manipal 
Address  Room number 215, Department of Physiotherapy, second floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Udupi, Karnataka - 576104

Udupi
KARNATAKA
576104
India 
Phone  9167958779  
Fax    
Email  abhipsha.majumder@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Manikandan Natarajan 
Designation  Additional Professor and Head of Department of Physiotherapy, MCHP, MAHE, Manipal 
Affiliation  Manipal College of Health Proessions, Manipal Academy of Higher Education, Manipal 
Address  Department of Physiotherapy, second floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Udupi, Karnataka - 576104

Udupi
KARNATAKA
576104
India 
Phone  9886898064  
Fax    
Email  mani.kandan@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Senthil D Kumaran 
Designation  Additional Professor 
Affiliation  Manipal College of Health Proessions, Manipal Academy of Higher Education, Manipal 
Address  Department of Physiotherapy, second floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Udupi, Karnataka - 576104

Udupi
KARNATAKA
576104
India 
Phone  9986910303  
Fax    
Email  senthil.kumaran@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Udupi, Karnataka - 576104 
 
Primary Sponsor  
Name  Manipal College of Health Professions 
Address  Room Number 215, Department of Physiotherapy, Second Floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Udupi, Karnataka - 576104 
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 Abhipsha Majumder  Kasturba Hospital  Dhanwantri Ward, 3rd floor, Kasturba Hospital, Udupi, Hebri Rd, Manipal, Udupi - 576104
Udupi
KARNATAKA 		 9167958779

abhipsha.majumder@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I639||Cerebral infarction, unspecified, (2) ICD-10 Condition: I619||Nontraumatic intracerebral hemorrhage, unspecified, (3) ICD-10 Condition: I609||Nontraumatic subarachnoid hemorrhage, unspecified, (4) ICD-10 Condition: I629||Nontraumatic intracranial hemorrhage, unspecified, (5) ICD-10 Condition: I679||Cerebrovascular disease, unspecified, (6) ICD-10 Condition: I699||Sequelae of unspecified cerebrovascular diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Physiotherapy without Visual Feedback  Participants in the control group will receive a total of 40 minutes of therapy per session. This includes 20 minutes of standard conventional physiotherapy followed by 20 minutes of trunk training exercises without any technology-based visual feedback. The trunk training comprises front/back, lateral, and diagonal movements aimed at improving postural alignment, trunk control, and sitting balance. Sessions are administered once daily for 5 consecutive days during the inpatient hospital stay. The treatment is delivered by a trained physiotherapist and mirrors the structure of the intervention group, ensuring consistency in dosage and delivery except for the absence of real-time visual feedback. 
Intervention  Technology-Based Trunk Training Using BTrackS™ Balance Tracking System  Participants in the intervention group will receive conventional physiotherapy for 20 minutes, followed by an additional 20-minute session of technology-based trunk training using the BTrackS™ Balance Tracking System. The BTrackS™ platform delivers real-time visual feedback to guide and improve trunk control and postural balance. The training includes structured trunk movements in multiple planes—forward/backward, lateral, and diagonal—as well as weight-shifting and target-tracking tasks designed to enhance dynamic sitting balance and trunk coordination. The intervention will be administered once daily for 5 consecutive days during inpatient care. Each session will be conducted under the supervision of a trained physiotherapist. The visual feedback provided by the device aims to enhance motor learning, patient engagement, and adherence. The platform is non-invasive, and all exercises are tailored to the individual’s capability, ensuring safety and feasibility in the acute post-stroke period. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. First-ever stroke confirmed by CT or MRI
2. Stroke onset between 48 hours to 5 days
3. Trunk Control Test score less than 60
4. Medically stable for participation
5. Ability to follow three-step commands 
 
ExclusionCriteria 
Details  1. Participants advised complete bed rest
2. Severe vertigo or postural hypotension
3. Severe visual impairment interfering with participation
4. Conditions limiting sitting (e.g., hip fracture) 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Trunk Impairment Scale (TIS)
2. Function in Sitting Test (FIST) 		 1. Baseline (Day 1) and daily post-treatment (Day 1 to Day 5)
2. Baseline (Day 1) and daily post-treatment (Day 1 to Day 5) 
 
Secondary Outcome  
Outcome  TimePoints 
Feasibility Metrics (Recruitment rate, Adherence rate, Dropout rate, Participant feedback)  Throughout intervention period (Day 1 to Day 5) 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/08/2025 
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 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   This pilot randomized controlled trial aims to compare the rate of trunk recovery in individuals with acute stroke undergoing conventional physiotherapy versus technology-based trunk training using the BTrackS Balance Tracking System. Thirty participants with first-onset stroke will be randomized into two groups. The intervention group will receive conventional physiotherapy followed by visual feedback-based trunk training using the BTrackS system. The control group will receive conventional physiotherapy with BTrackS training but without visual feedback. The primary outcome measures include the Trunk Impairment Scale and Function in Sitting Test assessed daily for five days. The study also evaluates feasibility, adherence, and participant feedback. The trial will be conducted in the Neurorehabilitation Unit of Kasturba Hospital, Manipal, over a period of twelve months. Ethical approval has been obtained and CTRI registration is being completed prospectively. 
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