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CTRI Number  CTRI/2024/05/066727 [Registered on: 03/05/2024] Trial Registered Prospectively
Last Modified On: 13/09/2025
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   To observe the effect of Multidirectional Step Exercise on Balance and Gait in individuals with chronic stroke  
Scientific Title of Study   Effect of Multidirectional Step Exercise on Balance and Gait in individuals with 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  Ayush Pitale  
Designation  Postgraduate Student - MPT 
Affiliation  All India Institute of Physical Medicine and Rehabilitation Mumbai  
Address  All India Institute of Physical Medicine and Rehabilitation,KK Marg,Haji Ali, Mahalaxmi, Mumbai

Mumbai
MAHARASHTRA
400034
India 
Phone  8369422315  
Fax    
Email  ayushnp99@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  R Ravindran 
Designation  Lecturer  
Affiliation  All India Institute of Physical Medicine and Rehabilitation Mumbai  
Address  All India Institute of Physical Medicine and Rehabilitation,KK Marg,Haji Ali, Mahalaxmi, Mumbai

Mumbai
MAHARASHTRA
400034
India 
Phone  9820264446  
Fax    
Email  ravindranlecturerpt@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ayush Pitale  
Designation  Postgraduate Student - MPT 
Affiliation  All India Institute of Physical Medicine and Rehabilitation Mumbai  
Address  All India Institute of Physical Medicine and Rehabilitation,KK Marg,Haji Ali, Mahalaxmi,Mumbai

Mumbai
MAHARASHTRA
400034
India 
Phone  8369422315  
Fax    
Email  ayushnp99@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy AIIPMR  
 
Primary Sponsor  
Name  Self 
Address  Department of Physiotherapy, AIIPMR, K K Marg, Haji Ali, Mahalaxmi, Mumbai 
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 Ayush Pitale  All India Institute of Physical Medicine and Rehabilitation   Room no.207,Department of Physiotherapy,AIIPMR,Mumbai
Mumbai
MAHARASHTRA 		 8369422315

ayushnp99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, AIIPMR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional balance exercises   Balance exercises will have static and dynamic components, which include the following- 1. sit to stand 2. heel to toe (tandem) walking 3. standing on foam surface with eyes open and then with eyes closed 4. single leg stance 5. marching 6. sideways and 7. Backward walking. The duration of this intervention is 30 minutes 
Intervention  Multidirectional Step Exercise   MSE will consist of 5 patterns for each lower limb- anterior, anterolateral, lateral, posterolateral, posterior which will be progressed over the period of 4 weeks. During every session each pattern will be practiced for 3 sets of 10 repetitions.The duration of this intervention is 30 minutes. Every pattern will be practiced initially at a comfortable pace to understand, once learned which will be progressed for both the lower limbs as below: 1. Straight steps- anterior, lateral and posterior directions 2. Oblique steps- anterolateral and posterolateral directions 3. Pattern speed ( from slow to fast) 4. Pattern complexity 5. Pattern complexity and speed 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Individuals with hemiplegia due to first time stroke(minimum
duration of onset-6 months) fulfilling the following criteria-
1. Mini-Mental status examination score greater than 24
2. The ability to maintain an independent standing posture for
30 seconds
3. They can walk independently with or without the use of an
assistive device for at least 3 m 
 
ExclusionCriteria 
Details  Any individual with clinical impairments involving
musculoskeletal/ cardiopulmonary/neurological other than
stroke/recent injuries that could possibly affect stepping
performance 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
mini-BESTest for Balance
Gait speed-10 metre walk test
Gait endurance- 6 minute walk test 		 Pre-Intervention and Post 4 weeks of Intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/05/2024 
Date of Study Completion (India) 03/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 03/06/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 Stroke has the second place among diseases causing long term disability based on the WHO report. The majority of stroke patients have some degree of balance and gait impairments. These impairments include inefficient stepping strategies, impaired anticipatory adjustments, reduced walking speed and reduced walking endurance leading to increased risk of falls and restricted activities of daily living.Several therapeutic strategies to improve balance and gait in stroke are designed such as perturbation training, training on unstable surface, multidirectional step exercise (MSE) and weight shift training.However the evidences of effect of MSE on balance and gait in stroke population are limited. The aim of this study was to determine the effect of multidirectional step exercise on balance and gait in individuals with chronic stroke. The objective of this study was to compare the effect of MSE and conventional balance exercises on balance and gait in individuals with chronic stroke.
Methodology- 30 participants with chronic stroke were screened according to inclusion and exclusion criteria. 26 participants were included and written consent was obtained. Concealed allocation of the participants into two groups was done using sealed envelope method. Preparatory exercises were given to both the groups. The experimental group were incorporated MSE as a progressive training strategy, while conventional exercises were incorporated in control group. The total duration for the exercise intervention was for 1 hour.
Outcome Measures:Balance and gait parameters were evaluated using standardized tools including the Mini-BESTest, 6-Minute Walk Test (6MWT), and 10-Meter Walk Test (10MWT) respectively.
Results & Conclusion:The present study found that both multidimensional step exercise (MSE) and conventional physiotherapy produced improvements in balance, gait speed, and walking endurance in chronic stroke patients after four weeks of intervention. Although the MSE group demonstrated slightly greater improvements in 
mini-BESTest scores, these changes did not reach statistical significance when compared with the control group. Similarly, gait speed and six-minute walk distance improved in both groups without significant between-group differences.
 
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