| CTRI Number |
CTRI/2018/03/012604 [Registered on: 15/03/2018] Trial Registered Prospectively |
| Last Modified On: |
11/04/2023 |
| 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
|
Benefits of using games in computer for the recovery of hand movements and memory in people with Parkinsons disease. |
|
Scientific Title of Study
|
Randomized trial on virtual reality and app based games on motor and cognitive function in Parkinsons disease. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Pooja Nagori |
| Designation |
Masters of Physiotherapy (MPT) student |
| Affiliation |
Manipal Academy of Higher Education (MAHE) |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Manipal Academy Of Higher Education (MAHE), Manipal Hospital, HAL Airport road,Bangalore.
Bangalore
KARNATAKA
5600017
India |
| Phone |
9619947017 |
| Fax |
|
| Email |
poojanagori1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Karthikbabu |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education (MAHE) |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Manipal Academy Of Higher Education (MAHE), Manipal Hospital, HAL Airport road,Bangalore
Bangalore
KARNATAKA
5600017
India |
| Phone |
9902338198 |
| Fax |
|
| Email |
karthikbabu78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Divya Mohan |
| Designation |
Asst. Professor - Senior Scale |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Manipal Academy Of Higher Education, Manipal Hospital, HAL Airport road,Bangalore
Bangalore
KARNATAKA
5600017
India |
| Phone |
9886794027 |
| Fax |
|
| Email |
dimspt2002@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy,School of Allied Health Sciences, Manipal Academy of Higher Education (MAHE), Manipal Hospital, 98, HAL Airport Road, Bangalore - 560017. |
|
|
Primary Sponsor
|
| Name |
SOAHS Manipal Academy Of Higher Education |
| Address |
Department of Physiotherapy, School of Allied Health Sciences,
Manipal Hospital, HAL Airport Road, Bangalore. |
| 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 |
| Ms Pooja Nagori |
Department of Physiotherapy, Manipal Hospital |
Department of Physiotherapy, Basement floor 1, School of Allied Health Science, Manipal Hospital,
HAL Airport Road, Bangalore.
Bangalore
KARNATAKA |
9619947017
poojanagori1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Parkinsons Disease, (1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Physical therapy includes warm up, stretches, strengthening and balance exercises.
The exercise session lasts for 45 minutes a day, 2 days a week over 6 weeks. |
| Intervention |
Virtual reality and app based games |
Virtual reality and app based games addresses on motor and cognitive function.
The exercise session lasts for 45 minutes a day, 2 days a week over 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Hoehn and Yahr scale 1-3
2) Good vision and hearing
3) No prior experience of virtual reality
|
|
| ExclusionCriteria |
| Details |
1) Parkinsons plus syndrome, Vascular Parkinsons disease and drug induced Parkinson disease
2) Surgery like Pallidectomy, deep brain stimulation
3) Any other neuromuscular disease like stroke, Alzheimers disease |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Unified Parkinson Disease Rating Scale. |
Two time points:
Baseline and 6 weeks post intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Balance Evaluation System Test
2)Addenbrooke cognitive examination (ACE-R)
3)The Montreal Cognitive Assessment
4)Parkinsons Disease Questionnaire (PDQ-39) |
Two time points:
Baseline and 6 weeks post intervention. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/03/2018 |
| Date of Study Completion (India) |
24/06/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Virtual reality is one of the rehabilitation tools used to optimize motor learning and cognition in Parkinson disease. It simulates computer-generated scenario by providing augmented feedback to participants which might improve their function.This study aims at examining the effect of virtual Reality and app-based games on the motor and cognitive function in Parkinson Disease.
|