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CTRI Number  CTRI/2025/05/087662 [Registered on: 26/05/2025] Trial Registered Prospectively
Last Modified On: 26/05/2025
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   How Foot Exercises Affect Balance in Stroke Patients 
Scientific Title of Study   Additional Effect Of Intrinsic Foot Muscles Exercise Program On Balance And Center Of Pressure Trajectory In Patient with Stroke: A Randomized Control 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  Vikram Dhade 
Designation  Post-graduate 
Affiliation  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 
Address  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, Department of NeuroPhysiotherapy 11/12,Thube Park, Shivaji Nagar, Pune. MAHARASHTRA 411005 India

Pune
MAHARASHTRA
411005
India 
Phone  7410751690  
Fax    
Email  vikramdhade18@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sadhana Mukhi 
Designation  Associate Professor 
Affiliation  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 
Address  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, Department of NeuroPhysiotherapy, 11/12, Thube Park, Shivaji Nagar, Pune. Pune MAHARASHTRA 411005 India

Pune
MAHARASHTRA
411005
India 
Phone  8007011772  
Fax    
Email  sadhananimbhore123@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sadhana Mukhi 
Designation  Associate Professor 
Affiliation  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 
Address  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, Department of NeuroPhysiotherapy, 11/12, Thube Park, Shivaji Nagar, Pune. Pune MAHARASHTRA 411005 India


MAHARASHTRA
411005
India 
Phone  8007011772  
Fax    
Email  sadhananimbhore123@gmail.com  
 
Source of Monetary or Material Support  
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, Pune - 411005 Maharshtra, India 
 
Primary Sponsor  
Name  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 
Address  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12, Thube Park, Shivaji Nagar, Pune 411005 MAHARASHTRA 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Vikram Dhade  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy  Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12, Thube Park, Shivaji Nagar, Pune 411005 MAHARASHTRA
Pune
MAHARASHTRA 		 7410751690

vikramdhade18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sancheti Institute for Orthopaedics and Rehabilitation Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I60-I69||Cerebrovascular diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Physiotherapy  Conventional protocol :-Proprioceptive Neuromuscular Facilitation (PNF) for the lower limb (extension abduction internal rotation). facilitation of the dorsiflexion from sitting then standing, Rhythmic stabilization in standing: pelvis against pelvis and pelvis against shoulder. Resisted exercises for hip extension and hip abduction in standing. Standing reach forward up then backward as far as possible. Ascending and descending a step alternatively with guidance for efficient eccentric contraction. Gait training by passing obstacles and alternatively trying to maintain symmetrical step length. Balance training through pushing the patient in different directions in standing with the supporting surface behind the patient and therapist in front of him for safety. 
Intervention  Instrinsic foot muscle exercise program  Big toe and lesser toe extension, Toe spread-out and squeeze, Short foot exercise, Towel curl, Marble pick-up and Big toe and lesser toe press. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Clinically diagnosed stroke patients (ischemic/hemorrhagic).
2. Ability to follow simple verbal commands.
3. Ability to stand/walk with or without assistance.
4. Voluntary control grade 4 to 5.
5. Age group – 35-65. 
 
ExclusionCriteria 
Details  1. Severe Contractures or Deformities – Fixed foot deformities that prevent normal foot function.
2. Severe Sensory Deficits – Complete loss of sensation in the foot affecting proprioception and balance.
3. Recent Fractures or Trauma to the Lower Limb – Any musculoskeletal injury within the past 6 months that limits weight-bearing
4. Severe Cardiopulmonary Conditions – Advanced COPD, heart failure (NYHA class III/IV), or recent myocardial infarction 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Plantar foot pressure  At 0 weeks and after 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Balance  At 0 weeks and after 6 weeks 
 
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)   07/06/2025 
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   Stroke impairs balance and mobility, with 75% of patients experiencing deficits that increase fall risks. While rehab focuses on hip and trunk muscles, intrinsic foot muscles play a key role in posture and stability but are often overlooked. Strengthening IFMs may improve balance, reduce postural sway, and enhance stroke recovery. This study examines their impact, aiming to integrate IFM exercises into rehabilitation for better outcomes.
NULL HYPOTHESIS: There is no significant difference in balance and center of pressure trajectory between stroke patients receiving intrinsic foot muscles exercise program and those receiving conventional rehabilitation.
ALTERNATE HYPOTHESIS: There is significant difference in balance and center of pressure trajectory between stroke patients receiving intrinsic foot muscles exercise program and those receiving conventional rehabilitation.
 
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