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CTRI Number  CTRI/2024/09/073929 [Registered on: 13/09/2024] Trial Registered Prospectively
Last Modified On: 09/09/2024
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   Improving Balance After Stroke: Comparing Two Rehabilitation Approaches 
Scientific Title of Study   To Compare The Effect of Motor Relearning Program Versus Physioball Based Exercises on Trunk Control and Balance In Post Stroke Patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sushant Kimothi 
Designation  Post Graduate Student 
Affiliation  Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences 
Address  Department of Physiotherapy, North Block, Lower Ground, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun Dehradun UTTARANCHAL

Dehradun
UTTARANCHAL
248001
India 
Phone  7895270635  
Fax    
Email  kimothisushant98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Niraj Kumar 
Designation  Professor 
Affiliation  Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences 
Address  Room no. 5, Department of Physiotherapy, North Block, Basement, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun

Dehradun
UTTARANCHAL
248001
India 
Phone  7895795277  
Fax    
Email  drnirajkumar25@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Niraj Kumar 
Designation  Professor 
Affiliation  Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences 
Address  Room no. 5, Department of Physiotherapy, North Block, Basement, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun

Dehradun
UTTARANCHAL
248001
India 
Phone  7895795277  
Fax    
Email  drnirajkumar25@gmail.com  
 
Source of Monetary or Material Support  
Shri Mahant Indresh Hospital, Patel Nagar, Dehradun, Uttrakhand, 248001 
 
Primary Sponsor  
Name  Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences 
Address  Department of Physiotherapy North Block, Lower Ground Shri Mahant Indresh Hospital Patel Nagar Dehradun 
Type of Sponsor  Private 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 
Sushant Kimothi  Shri Mahant Indresh Hospital  Department of physiotherapy, North Block, Lower Ground, Patel Nagar, dehradun Dehradun
Dehradun
UTTARANCHAL 		 7895270635

kimothisushant98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee, Shri Guru Ram Rai Institute of Medical and Health Sciences, Patel Nagar, Dehradun  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G839||Paralytic syndrome, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Motor Relearning Program  Group A participates in a comprehensive Motor Relearning Program aimed at improving various aspects of mobility and balance. The program includes exercises designed to enhance seated and standing stability, such as maintaining balanced sitting on a firm surface with hands in lap and feet flat on the floor. It also involves standing exercises with feet apart and hands at the sides, with therapist support to stabilize the affected knee. Additionally, participants practice transitioning between sitting and standing positions without upper body flexion, and perform walking exercises to improve gait and weight distribution. Head and trunk movements, reaching actions in different directions, and specific techniques to aid in standing up and sitting down are also integrated into the program. These exercises are tailored to facilitate motor control and functional movement patterns, crucial for post-stroke rehabilitation. Each subject will receive treatment for 3 sessions per week for 60 minutes session for 8 weeks. 
Comparator Agent  Physioball exercise  Group B will undergo a series of physioball exercises aimed at improving trunk control and balance through various positions and movements. In supine lying, exercises include pelvic bridging, where the patient lifts the pelvis off the surface with legs on the physio ball, gradually advancing to include unilateral bridging and trunk rotation. Upper and lower trunk rotations involve moving the ball with the legs to both sides, starting from beneath the knees and progressing towards the ankles. In sitting, exercises focus on static balance and dynamic movements such as trunk flexion-extension, lateral flexion of the lower trunk, and rotations of both the upper and lower trunk. Participants perform these exercises while seated on the physio ball, engaging in task-specific reaches and weight shifts to enhance stability and mobility. The program aims to optimize functional movement patterns and core strength essential for post-stroke rehabilitation. Each subject will receive treatment for 3 sessions per week for 60 minutes session for 8 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  To be eligible for the study, participants must meet the following criteria: They should be over 40 years of age and have experienced their first-ever stroke, which should be either ischemic or hemorrhagic and have occurred within the past six months. The participant must have unilateral weakness and possess a muscle power grade of 2 or higher. Additionally, they must have a Mini-Mental State Examination (MMSE) score of 24 or higher and be capable of standing independently for at least one minute. Both the patient and their legal guardian should be able to provide informed consent 
 
ExclusionCriteria 
Details  Patients who have experienced a stroke and exhibit major cognitive deficits are ineligible for the study if they also have communication impairments. Additionally, individuals with contraindications to starting rehabilitation, such as uncontrolled hypertension, uncontrolled diabetes, or unstable angina, cannot participate. Furthermore, patients with a history of neurological deficits other than stroke are excluded from the study. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Trunk impairment scale  1st Day, 28th Day, 56th Day 
 
Secondary Outcome  
Outcome  TimePoints 
Brunel balance assessment  1st Day, 28th Day, 56th Day 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   21/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/09/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
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   The study will involve a total of 32 patients selected through a simple random sampling method, with 16 patients assigned to each of the two groups. Participants will be recruited from the SGRR SMI Hospital’s In Patient Door (IPD) and Out Patient Door (OPD) Department of Physiotherapy in Patel Nagar, Dehradun. Inclusion and exclusion criteria will guide patient selection, and informed consent will be obtained from the patients’ family members, detailing the study’s purpose and methodology. Data analysis will be conducted according to established protocols, focusing on the comparison of variables across both groups to assess the outcomes of the interventions. 
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