| CTRI Number |
CTRI/2019/09/021225 [Registered on: 13/09/2019] Trial Registered Prospectively |
| Last Modified On: |
12/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
a study to check Effect of Virtual Reality games and Balance exercises on Balance and Quality of life in patients with Parkinsons Disease. |
|
Scientific Title of Study
|
Effect of Virtual Reality Balance exercises on Balance and Quality of life in patients with Parkinsons Disease: An Experimental Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajesh S Vasava |
| Designation |
Post Graduate Student |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Room no- 8,Research Lab,
1st floor,
School of Physiotherapy, RK UNIVERSITY, Kasturbadham, Rajkot-Bhavnagar Highway
Rajkot
GUJARAT
360020
India |
| Phone |
8849810726 |
| Fax |
|
| Email |
rvasava047@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krupa Raithatha |
| Designation |
Assistant Professor |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
Staff room,
School of Physiotherapy, RK UNIVERSITY, Kasturbadham, Rajkot-Bhavnagar Highway
Rajkot
GUJARAT
360020
India |
| Phone |
9898141466 |
| Fax |
|
| Email |
krupa.raithatha@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Rajesh S Vasava |
| Designation |
Post Graduate Student |
| Affiliation |
School of Physiotherapy, RK University |
| Address |
School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway
Rajkot
GUJARAT
360020
India |
| Phone |
8849810726 |
| Fax |
|
| Email |
rvasava047@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| Rajesh S. Vasava
RK Physiotherapy research and rehabilitation center,
Bhaktinagar Circle, Rajkot |
|
|
Primary Sponsor
|
| Name |
Rajesh S Vasava |
| Address |
School of Physiotherapy, RK University, Kasturbadham, Rajkot-Bhavnagar Highway, Rajkot, Gujrat, India. |
| Type of Sponsor |
Other [Self ] |
|
|
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 Monika Vekariya |
RK Physiotherapy Rehabilitation and Research Center |
Bhaktinagar circle,
Opp. Meghani Rangbhavan,
Rajkot
Rajkot
GUJARAT |
7874800092
monika.vekariya@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, School of Physiotherapy, RK University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Berg Balance Scale
PDQ 39
Time Up and Go test |
day-1 and after 6 weeks |
| Intervention |
Virtual Reality |
day-1 and after 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Hoehn and Yahr stages I to III
Ability to walk independently
Stable medication Usage
With or without deep brain stimulation
Score of ≥24 on the Mini-Mental State Examination
|
|
| ExclusionCriteria |
| Details |
Unstable medical condition
History of other neurological, cardiopulmonary, or orthopedic diseases known to interfere with participation in the study
Past history of seizure
Use of cardiac pacemaker
Vision deficits
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Berg Balance Scale
PDQ 39
Time Up and Go test
|
day 1 and after 6 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time Up and Go test |
day 1 and after 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
|
N/A |
|
Date of First Enrollment (India)
|
16/09/2019 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
BACKGROUND: Parkinson is a
chronic, progressive neurodegenerative disorder which leads to balance problems
and impairment in quality of life. Virtual reality is computer based advance
technology can help the patients to develop the motor control, functional
mobility and balance.
AIM: To check the
effectiveness of virtual reality on balance and Quality of life in Patient with
Parkinson’s disease.
OBJECTIVE: Objective of the study is to evaluate the effect of virtual reality over conventional
Physiotherapy balance exercises on balance and quality of life in patients with
Parkinson’s Disease.
METHOD: Total 30 subjects of
age 50-70 years (male and female) having Parkinson`s disease will be included in the study
on the basis of selection criteria. The patients will be divided into two
group. Group A will receive conventional balance exercises along with virtual
reality balance training and Group B will receive conventional balance
exercises for 30 minutes,5 times a week for 6 weeks. Static Balance will be assessed
using Berg Balance Scale, Dynamic Balance will be assessed using Time Up and Go
test and Quality of Life will be assessed using Parkinson’s Disease Questioner
Outcome measure will be taken on day 1 and after
6 weeks. |