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CTRI Number  CTRI/2025/09/094950 [Registered on: 17/09/2025] Trial Registered Prospectively
Last Modified On: 16/09/2025
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   How treadmill training with body support can help stroke survivors to walk faster and improve daily activities 
Scientific Title of Study   The effect of Body Weight Supported Treadmill Training (BWSTT) on Gait speed and Function in stroke survivors 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Komal 
Designation  Post Graduate Student 
Affiliation  College of Physiotherapy, PGIMS, Pt. B.D. Sharma University of Health Sciences 
Address  Physiotherapy Department, E- Block, College of Physiotherapy, PGIMS, Rohtak Rohtak HARYANA 124001 India

Rohtak
HARYANA
124001
India 
Phone  9306424404  
Fax    
Email  9306424404komal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhawna Verma 
Designation  Associate Professor 
Affiliation  College of Physiotherapy, PGIMS, Pt. B.D. Sharma University of Health Sciences 
Address  Physiotherapy Department, Faculty room , E-Block, College of Physiotherapy, PGIMS, Rohtak Rohtak HARYANA 124001 India

Rohtak
HARYANA
124001
India 
Phone  9992822644  
Fax    
Email  Bhawna_pt@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Bhawna Verma 
Designation  Associate Professor 
Affiliation  College of Physiotherapy, PGIMS, Pt. B.D. Sharma University of Health Sciences 
Address  Physiotherapy Department, Faculty room , E-Block, College of Physiotherapy, PGIMS, Rohtak Rohtak HARYANA 124001 India

Rohtak
HARYANA
124001
India 
Phone  9992822644  
Fax    
Email  Bhawna_pt@yahoo.co.in  
 
Source of Monetary or Material Support  
Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India, 124001  
 
Primary Sponsor  
Name  Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India, 124001 
Address  College of Physiotherapy, Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India, 124001 
Type of Sponsor  Government medical college 
 
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 Bhawna Verma  Pt. B.D. Sharma PGIMS , Rohtak  Neurology OPD, Room No. 131, Ch. Ranbir Singh OPD , Pt. B.D. Sharma PGIMS Rohtak,  HARYANA
Rohtak
HARYANA 		 9992822644

Bhawna_pt@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research 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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Body Weight Supported Treadmill Training and Conventional Rehabilitation Exercises  It will be given as 3 week of conventional rehabilitation in 3 session /week for 30 minutes each day along with 30 minutes of BWSTT will be given per session. 
Comparator Agent  Conventional Rehabilitation exercises.  The control group will receive conventional rehabilitation only for 3 weeks in 3 session / week of 30 minutes duration .  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Participants aged eighteen years and above.
2. Diagnosis of stroke confirmed by magnetic resonance imaging or computed tomography scan.
3. Stroke onset duration between three weeks and eleven weeks.
4. Ability to walk for at least ten meters with the assistance of an orthosis or mobility aid. 
 
ExclusionCriteria 
Details  1.Having had recurrent strokes.
2.Serious cardiovascular or respiratory system disease.
3.Unable to understand simple commands because of language or cognitive disorder.
4.Functional ambulation categories stage 0 and stage 1.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. 6 min. walk test
2. Barthel Index 		 Baseline , Post Intervention (3 weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
1. 10 meter walk test
2. Functional ambulation category

3. Time up and go test

 		 Baseline, Post Intervention ( 3 weeks ) 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   30/09/2025 
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   Background :
Stroke is rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than of vascular origin. Decrease walking speed and functional status are common complications in stroke patients. While conventional exercise programs have shown benefits,  there is limited research on combined use of body weight supported treadmill training with conventional rehabilitation exercises.
Objective :
To study the effect of BWSTT combined with conventional rehabilitation on walking speed, endurance, mobility, and functional and ambulatory status in stroke survivors.
Methods :
A true experimental pretest - posttest design was used with 40 patients diagnosed with stroke . Participants were randomly allocated into two groups :
  • Group A ( n = 20 ) : Body Weight Supported Treadmill Training + Conventional Rehabilitation Exercises ( experimental group )
  • Group B ( n = 20 ) : Conventional Rehabilitation Exercises ( control group ) 
Intervention was conducted over 3 weeks ; 3 sessions per week. Outcome measures were 6 min. Walk test ,10 meter walk test , Barthel index, Functional ambulation category scale and Time up and go test .Data analysis was performed using descriptive statistics and t tests .
Result :
Results are analyzed to be post intervention. It is hypothesized that the combined body weight supported treadmill training with conventional rehabilitation exercises  group will show statistically significant improvement in gait speed, endurance , functional and ambulatory status as compared to conventional rehabilitation exercises alone.
Conclusion : 
This study aims to provide evidence supporting body weight supported treadmill training to improve gait speed, endurance, functional and ambulatory status in stroke survivors. If effective this approach could be adopted in rehabilitation protocol of stroke survivors.
 
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