| CTRI Number |
CTRI/2025/12/098694 [Registered on: 09/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of games using Imagined reality on an electronic device combined with wearable vibratory bands on freezing of gait and features of walking in individuals with Parkinson’s disease- An Experimental Study |
|
Scientific Title of Study
|
Effect of Augmented Reality gaming combined with wearable sensory cueing on freezing of gait and temporospatial parameters of gait in individuals with Parkinson’s disease- An Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aastha Shah |
| Designation |
PG student |
| Affiliation |
DY Patil deemed to be University, School of Physiotherapy |
| Address |
School Of Physiotherapy, 6th Floor, School of Medicine Building, Plot No-2. Sector -5, Nerul, Navi Mumbai- 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
8108866887 |
| Fax |
|
| Email |
abs.nbs.bms.2018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amruta Nerurkar |
| Designation |
Professor |
| Affiliation |
DY Patil deemed to be University, School of Physiotherapy |
| Address |
School Of Physiotherapy, 6th Floor, School of Medicine Building, Plot No-2. Sector -5, Nerul, Navi Mumbai- 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9967910372 |
| Fax |
|
| Email |
amruta.nerurkar@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amruta Nerurkar |
| Designation |
Professor |
| Affiliation |
DY Patil deemed to be University, School of Physiotherapy |
| Address |
6th Floor, Plot No2. Sector 5, Nerul, Navi Mumbai 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9967910372 |
| Fax |
|
| Email |
amruta.nerurkar@dypatil.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DY Patil deemed to be University, School of Physiotherapy |
| Address |
6th Floor, Plot No2. Sector 5, Nerul, Navi Mumbai 400706 |
| 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 |
| Aastha Shah |
DY Patil Hospital and Research Centre |
3rd Floor, Multi-Speciality Physiotherapy OPD Plot No2. Sector 5, Nerul, Navi Mumbai 400706
Thane
MAHARASHTRA |
08108866887
abs.nbs.bms.2018@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee For Biomedical And Health Research |
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 |
| Intervention |
augmented reality based games and gait training with sensory cueing device |
15 minutes of training with augmented reality based games followed by 15 minutes of gait training with sensory cueing device. |
| Comparator Agent |
gait training with wearable sensory cueing device. |
15 minutes of basic mobility and breathing exercises followed by 15 minutes of gait training with wearable sensory cueing device. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with idiopathic Parkinsons disease
Higher NFOG Q score (moderate and severe which include those who have experienced freezing once a week and whose longest freezing episode is atleast 3 to 10sec according to new FOG questionnaire)
Modified Hoehn and Yahr upto stage 3
Can walk independently
|
|
| ExclusionCriteria |
| Details |
Impaired cognition (MMSE more than 23)
Any acute medical illness
Any other neurological condition
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Zieglers test for freezing of gait and temporospatial parameters of gait like cadence, speed and step length |
2 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
20/12/2025 |
| 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="5"
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
|
•Among all the therapies for freezing of gait in individuals with Parkinson’s disease, visual, auditory and proprioceptive stimuli have proven to reduce freezing episodes, improve stride length variability, cadence, stride length and speed. •Vibratory devices that are available including WALK device have shown significant effect on gait velocity and reducing freezing episodes.Game based (video game) therapy has proved to have positive effect on walking abilities, freezing of gait and quality of life.But the combined effect of proprioceptive stimuli (vibration) and game based therapy is not known yet. •So, in this study using WALK device, we will combine the vibration stimuli and gamified therapy and see its effect on freezing of gait in Parkinson’s patients. •Hence this study aims to determine the effect of a wearable sensory cueing device on freezing of gait and the additional effect of training with Augmented reality games combined with sensory cueing on freezing of gait and temporospatial parameters in individuals with Parkinson’s disease |