| CTRI Number |
CTRI/2022/03/040836 [Registered on: 04/03/2022] Trial Registered Prospectively |
| Last Modified On: |
13/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Video-gaming for children with cerebral palsy. |
|
Scientific Title of Study
|
Enabling Functional Mobility through Integrated Wearable Sensor-based Gait Analysis and Virtual Reality |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karthikbabu S |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Hospital, HAL Airport Road, Bangalore
Bangalore
KARNATAKA
560017
India
Bangalore
KARNATAKA
560017
India |
| Phone |
9902338198 |
| Fax |
|
| Email |
karthik.babu@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Sakshi Gandhe |
| Designation |
Research Assistant |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Hospital, HAL Airport Road, Bangalore
Bangalore
KARNATAKA
560017
India
Bangalore
KARNATAKA
560017
India |
| Phone |
8793687477 |
| Fax |
|
| Email |
sakshigandhe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prem V |
| Designation |
HOD and Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Hospital, HAL Airport Road, Bangalore
Bangalore
KARNATAKA
560017
India
Bangalore
KARNATAKA
560017
India |
| Phone |
9886647732 |
| Fax |
|
| Email |
prem.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Biotechnology Industry Research Assistance Council BIRAC |
|
|
Primary Sponsor
|
| Name |
Biotechnology Industry Research Assistance Council BIRAC |
| Address |
1st Floor ,MTNL Building ,9, Lodhi Rd, CGO Complex, Pragati Vihar, New Delhi, Delhi 110003 |
| Type of Sponsor |
Government funding agency |
|
|
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 Senthil |
The Association of People with Disability |
6th Cross, Hutchins Road, Lingarajapuram, St. Thomas Town Post, Bangalore, Karnataka, Karnataka 560084
Bangalore
KARNATAKA |
9739940421
senthilnsk@apd-india.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinical research committee, Manipal hospital, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G808||Other cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Virtual Reality |
Virtual Reality car game with components of trunk flexion, extension, side flexion, stepping over obstacles and reaching out activities.
Dosage- 30 minutes/day for 3 sessions/week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Children with Cerebral Palsy in GMFCS levels I-III
2. Atypical gait - Hemiplegic, diplegic, ataxic, dyskinetic
3. Age: 7 to 14 years
4. Able to follow instructions and communicate
5. Able to hold the controls to operate the VR system |
|
| ExclusionCriteria |
| Details |
1. Children with learning disability or impaired cognition
2. Children who have undergone any recent surgery within the last 3 months
3. Children who have had botox treatment within the last 3 months
4. Children with any visual or hearing deficits which may hamper their ability to use the VR system
5. Children with underlying comorbidities like cardio respiratory or other neurological conditions which limit the child’s participation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pediatric balance scale |
Two time points.
Pre treatment level and after four weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Spatial gait parameters
2. Temporal gait parameters |
Two time points.
Pre treatment level and after four weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/03/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Virtual Reality (VR) is an effective, innovative treatment approach which engages the child and has potential to improve functional mobility of children with cerebral palsy. This study will be done to apply a customized VR environment to a population of cerebral palsy (CP) children with gait abnormalities. It will be performed along with a sensor based real time gait analysis to provide a richer environment for motor learning and training balance. |