| 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
|
|
|
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
|
|
|
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 . |