| CTRI Number |
CTRI/2024/09/074286 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
19/09/2024 |
| 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
|
Comparing VR and Physical Games for hand function in Post-Stroke Physiotherapy |
|
Scientific Title of Study
|
Effectiveness of Virtual Reality Games Versus Physical Games as an Adjunct to
Conventional Physiotherapy For Improving Upper Limb Function in Post Stroke Hemiplegics |
| 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. Sakshi Sabhagchandani |
| Designation |
MPTh |
| Affiliation |
MAEERS College of Physiotherapy Talegaon Dabhade pune |
| Address |
MAEERS College of Physiotherapy , A-229 Neuroscience Physiotherapy department,OPD Building 2 Floor Near talegaon dabhade railway station , talegaon dabhade pune
Pune
MAHARASHTRA
410507
India |
| Phone |
9112909610 |
| Fax |
|
| Email |
sabhagchandanisakshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sayli Paldhikar |
| Designation |
Professor |
| Affiliation |
MAEERS College of Physiotherapy Talegaon Dabhade pune |
| Address |
MAEERS College of Physiotherapy ,A- 220 OPD Building 2 Floor Near talegaon dabhade railway station , talegaon dabhade pune
Pune
MAHARASHTRA
410507
India |
| Phone |
8805174616 |
| Fax |
|
| Email |
saylithuse@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sayli Paldhikar |
| Designation |
Professor |
| Affiliation |
MAEERS College of Physiotherapy Talegaon Dabhade pune |
| Address |
MAEERS College of Physiotherapy , A 220 OPD Building 2 Floor Near talegaon dabhade railway station , talegaon dabhade pune
MAHARASHTRA
410507
India |
| Phone |
8805174616 |
| Fax |
|
| Email |
saylithuse@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAEERS College of Physiotherapy Talegaon Dabhade Pune 410507 |
|
|
Primary Sponsor
|
| Name |
MAEERS College of Physiotherapy Talegaon Dabhade Pune 410507 |
| Address |
MAEERS Colege of Physiotherapy OPD building 2nd floor near talegaon dabhade railway station Talegaon Dabhade 410507 |
| Type of Sponsor |
Private medical college |
|
|
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 Sayli Paldhikar |
MAEERS College of Physiotherapy, Talegaon, Dabhade |
MAEERS College Of Physiotherapy ,A 229 Neuroscience Physiotherapy department OPD building 2nd floor near talegaon railway station talegaon dabhade 410507
Pune
MAHARASHTRA |
8805174616
saylithuse@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAEERS Physiotherapy college Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Post Stroke Hemiplegics |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Physical Games |
Effect of Physical games games along with conventional physiotherapy for upper limb function in post stroke hemiplegics will be given for 4 weeks, 3 times a week. Pre and post assessment will be done. |
| Intervention |
Virtual Reality |
Effect of Virtual reality games using VR device along with conventional physiotherapy for upper limb function in post stroke hemiplegics will be given for 4 weeks, 3 times a week. Pre and post assessment will be done. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Acute and subacute post stroke hemiplegics .
Above 18 years .
post stroke hemiplegics having grade 3 to 4 on brunnstorm stages of recovery grading for upper limb .
Post stroke hemiplegics who fit in level 2 and level 3 of GRASP program |
|
| ExclusionCriteria |
| Details |
patient with any deformity in hand
patients with bilateral stroke
MMSE score less than 24 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| MESUPES ( Motor Evaluation Scale For Upper Extremity in Stroke ) |
0 week and 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Handheld Dynamometer |
0 week and 4 week |
|
|
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 2 |
|
Date of First Enrollment (India)
|
19/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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 is a prevalent cause of physical disability, emphasizing the importance of rehabilitation for survivors. Motivating survivors during the long and challenging rehabilitation process is crucial. Various approaches like aquatic therapy and tai chi are used for multidisciplinary rehabilitation, aiming for improved function and quality of life. Extending rehabilitation programs may lead to additional benefits for stroke survivors. Persistent upper limb dysfunction post-stroke poses a significant challenge in rehabilitation, with motor impairments like muscle weakness and decreased sensation being common. The severity and extent of these impairments vary depending on lesion location and size. Tailoring therapy to individual impairments is crucial for maximizing functional recovery. Virtual Reality technology is increasingly used in physical therapy to enhance outcomes efficiently. Virtual Reality (VR) relies on subject-computer interaction via specialized software, providing real-time feedback based on sensory inputs. VR exercises should mimic daily activities. Game-based VR treatments complement traditional therapy, potentially reducing therapist workload and expediting rehabilitation. Identifying effective games for enhancing upper limb function is crucial. Combining games with traditional physiotherapy has shown improvements in upper limb functionality in healthy individuals. While VR can enhance therapy, its cost and complexity limit widespread use and research. Integrating VR games with conventional physiotherapy for stroke rehabilitation shows promise compared to standard therapy alone. However, more research is needed on the effectiveness of physical games in post-stroke upper limb function improvement. Comparing the effectiveness of Virtual Reality (VR) games and physical games as supplements to conventional physiotherapy in stroke rehabilitation is lacking in research. This study aims to evaluate the efficacy of these approaches to optimize cost-effective rehabilitation protocols for stroke patients. |