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CTRI Number  CTRI/2025/08/093294 [Registered on: 20/08/2025] Trial Registered Prospectively
Last Modified On: 19/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA)
Other (Specify) [Exergaming]  
Study Design  Other 
Public Title of Study   A study to compare the effects of video game based exercises and standard physiotherapy on leg movement and mobility in stroke patients. 
Scientific Title of Study   Effect of Exergaming Vs Standard Physiotherapy care on Lower Limb Mobility in Stroke patients: A Comparative study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aditi Shah 
Designation  MPT Scholar 
Affiliation  KJ Somaiya college of Physiotherapy 
Address  KJ Somaiya college of Physiotherapy, Neurophysiotherapy Department, Ayurvihar Complex, Eastern Express Highway, Sion, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400022
India 
Phone  7045787716  
Fax    
Email  aditishahpt@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dipali Suvarna  
Designation  PHD Scholar, Associate Professor, Neurophysiotherapy Department  
Affiliation  KJ Somaiya college of Physiotherapy 
Address  KJ Somaiya college of Physiotherapy, Neurophysiotherapy Department, Ayurvihar Complex, Eastern Express Highway, Sion, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400022
India 
Phone  8767039845  
Fax    
Email  dipali.suvarna@somaiya.edu  
 
Details of Contact Person
Public Query  
Name  Dipali Suvarna  
Designation  PHD Scholar, Associate Professor, Neurophysiotherapy Department  
Affiliation  KJ Somaiya college of Physiotherapy 
Address  KJ Somaiya college of Physiotherapy, Neurophysiotherapy Department, Ayurvihar Complex, Eastern Express Highway, Sion, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400022
India 
Phone  8767039845  
Fax    
Email  dipali.suvarna@somaiya.edu  
 
Source of Monetary or Material Support  
KJ Somaiya College of Physiotherapy, Ayurvihar complex, Eastern Express Highway, Sion, Mumbai 400022 
 
Primary Sponsor  
Name  Aditi Shah 
Address  KJ Somaiya college of Physiotherapy, Neurophysiotherapy Department, Ayurvihar Complex, Eastern Express Highway, Sion, 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 Aditi Shah  KJ Somaiya college of physiotherapy  Neurophysiotherapy Department, Adult Neuro OPD, Ayurvihar complex, Eastern Express Highway, Sion, Mumbai-400022
Mumbai (Suburban)
MAHARASHTRA 		 7045787716

aditishahpt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, KJ Somaiya College of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G968||Other specified disorders of central nervous system, (2) ICD-10 Condition: G968||Other specified disorders of central nervous system, (3) ICD-10 Condition: G968||Other specified disorders of central nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Exergaming  Exergaming for lower limb mobility and standard physiotherapy care for upper limb, bed mobility, balance and gait for 4 weeks which includes 12 sessions. 
Comparator Agent  standard physiotherapy care   standard physiotherapy care for upper and lower limb mobility, gait, balance and bed mobility for 4 weeks that includes 12 sessions 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  Individuals of age group 18 to 59 years
old, with first episode of unilateral stroke (8th day to 2 years), Mini-Mental State Examination score more than or equal to 24, Functional Ambulation Category grade more than or equal to 2 , Score of more than or equal to 1 in each category measuring volitional movement in supine, sitting and standing position in Fugl Meyer Assessment-Lower Limb (FMA-LE), Willing to participate in the study. 
 
ExclusionCriteria 
Details  Individuals with lower limb impairment caused by other diagnosed neurological diseases or musculoskeletal diseases. Individuals diagnosed with psychiatric conditions, perceptual disorders and or or uncorrected visual, auditory impairments. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Lower limb mobility by FMA LE, TUG test   pre and post 4 weeks of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   01/09/2025 
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="6"
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   This comparative experimental study will evaluate the effect of exergaming versus standard physiotherapy care on lower limb mobility in adults aged 18–59 years with subacute or chronic stroke. Thirty-four participants will be randomly allocated to either an exergaming plus standard physiotherapy group or a standard physiotherapy–only group, receiving thrice-weekly sessions for 4 weeks. Lower limb mobility will be assessed using the Fugl-Meyer Assessment–Lower Extremity and Timed Up and Go Test before and after intervention. The study aims to determine whether adding exergaming improves functional mobility outcomes compared to standard physiotherapy alone. 
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