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CTRI Number  CTRI/2024/07/070644 [Registered on: 15/07/2024] Trial Registered Prospectively
Last Modified On: 11/07/2024
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   Impact of Motorized Cycle Exercise Video Games on Leg Functions in Stroke Patients: 6-Week Follow-Up Study 
Scientific Title of Study   Effect of exergaming with active passive trainer on lower extremity functions in patients with stroke: A pilot randomized controlled 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  Dr Smitesh Patil 
Designation  Postgraduate student 
Affiliation  MGM Institute of physiotherapy 
Address  Department of Neuro physiotherapy,OPD-5,MGM Institute of physiotherapy, Aurangabad, Maharashtra, 431003, India

Aurangabad
MAHARASHTRA
431003
India 
Phone  7972534963  
Fax    
Email  smithpatil1999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gaurav Mhaske  
Designation  Assistant Professor  
Affiliation  MGM Institute of physiotherapy 
Address  Department of Neuro physiotherapy,OPD-5,MGM Institute of physiotherapy, Aurangabad, Maharashtra, 431003, India

Aurangabad
MAHARASHTRA
4311003
India 
Phone  9960404041  
Fax    
Email  gauravmhaske@mgmiop.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Smitesh Patil 
Designation  Postgraduate student 
Affiliation  MGM Institute of physiotherapy 
Address  Department of Neuro physiotherapy,OPD-5,MGM Institute of physiotherapy, Aurangabad, Maharashtra, 431003, India

Aurangabad
MAHARASHTRA
431003
India 
Phone  7972534963  
Fax    
Email  smithpatil1999@gmail.com  
 
Source of Monetary or Material Support  
MGM Institute of Physiotherapy, N-6,Cidco,Aurangabad,431003, Maharashtra, India 
 
Primary Sponsor  
Name  MGM Institute of Physiotherapy 
Address  N-6,Cidco,Aurangabad,431003, Maharashtra,India  
Type of Sponsor  Research institution and hospital 
 
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 Smitesh Patil  MGM Institute of Physiotherapy  Department of Neuro Physiotherapy,OPD-5, MGM Institute of Physiotherapy,N-6,Cidco,Aurangabad,Maharashtra
Aurangabad
MAHARASHTRA 
7972534963

smithpatil1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MGM Institute of Physiotherapy Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G811||Spastic hemiplegia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional exercises   Conventional exercises will be give to Patients who are diagnosed with stroke from 1 month to 1 year 
Intervention  Exergaming with Active passive trainer plus conventional exercises  Exergaming with Active passive trainer plus conventional therapy will be given to Patients who are diagnosed with stroke from 1 month to 1 year  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Patients who are diagnosed with stroke from 1 month to 1 year
2.Both male and female.
3.Patients with the first episode of stroke.
4.Mini-Mental State Examination Score more than 24
5.Brunnstrom motion recovery stage of 4 or greater.
 
 
ExclusionCriteria 
Details  1.Vision defects such as Blindness and visual field defects.
2.Hearing impairments such as deafness
3.Cardiovascular diseases such as unstable heart diseases
4.Musculoskeletal problems such as severe arthritis and fracture
5.Other Neurological problems such a History of seizures or epilepsy, Parkinson disease, multiple sclerosis, peripheral neuropathy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Lower extremity functions   Pre and post intervention period (6 weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
Endurance   Pre and post intervention period (6 weeks) 
Functional independence   Pre and post intervention period (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   Phase 3 
Date of First Enrollment (India)   22/07/2024 
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  

Patients with stoke will be included in the study trial if they met the inclusion criteria. The written and oral consent of all patients will be taken, and procedure will be explained. Demographic data will be noted. Patients will be screened according to inclusion and exclusion criteria and eligible participants will be included in the study. Before collection of the data, patients will be explained about the study aim and procedure in detail and informed written consent will be obtained from the patients. The participants will be interviewed and the information will be gathered about their demographic data, health related information like past medical history, duration since stroke, investigations. The Pre assessment data will be obtained using Fugl-Meyer scale for lower limb, Time up and go test, 6-minute walk test and functional independence scale. Participants will divide into two groups intervention group and control group using a computer generated numbers. The intervention will be given for 5 days/ week for 6 weeks(21,29). The intervention will include a 20-45minute exergaming session with active passive trainer, followed by a conventional therapy session. In this study, we will utilize an Active Passive Trainer (Kinetic Kinevia) in conjunction with a laptop running the Zwift application. The Zwift application, preinstalled on the laptop, offers a user-friendly interface allowing navigation through various virtual worlds such as Watopia, a fictional island, and customization of avatars. Zwift tracks various performance metrics, such as distance, speed, and power output, allowing patients to monitor their progress over time and set goals for improvement. Experience points are earned by completing rides, races, or other activities in Zwift. As users accumulate XP, they level up and unlock new virtual items, routes, and challenges. Leveling up can also provide access to advanced training plans and workouts. Experience points are earned by completing rides, workouts, races, or other activities in Zwift.  Speed sensors will be affixed to the patient’s paretic limb using a strap, establishing wireless communication with the Zwift application on the laptop through Bluetooth connectivity. These sensors will detect movement patterns as the patient pedals, facilitating the synchronization of the avatar’s speed within the virtual environment to correspond with the patient’s pedaling speed. This alignment of the avatar’s speed and the patient’s actual pedaling motion will significantly enhance the immersive experience, fostering improved concentration and engagement during training sessions. Data collection will be done before 1st week of intervention and at the end of 6th week of intervention. Data will be entered in Microsoft Excel analyzed using SPSS (Statistical Package for Social Science) version 27.0 and graph pad prism 7.0 version. The data will be represented in the form of visual impression like line diagram, bar diagram and statistical analysis will be done .

 


 
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