| CTRI Number |
CTRI/2025/05/086248 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
03/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing virtual reality and conventional gait training on gait in parkinsons disease |
|
Scientific Title of Study
|
Effect of virtual reality versus conventional training on gait parameters using motion analysis (X-SENS) in Parkinsons disease. |
| 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 Nishigandha Deodhe |
| Designation |
Assistant Professor |
| Affiliation |
Department of Neurophysiotherapy, Ravi Nair Physiotherapy College, Datta meghe institute of higher education and research, Sawangi Meghe, Wardha, Maharashtra, India |
| Address |
Department of Neurophysiotherapy,Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9284834850 |
| Fax |
|
| Email |
nishigandha.deodhe@dmiher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishigandha Deodhe |
| Designation |
Assistant Professor |
| Affiliation |
Department of Neurophysiotherapy,Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, Maharashtra, India |
| Address |
Department of Neurophysiotherapy,Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha
MAHARASHTRA
442001
India |
| Phone |
9284834850 |
| Fax |
|
| Email |
nishigandha.deodhe@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishigandha Deodhe |
| Designation |
Assistant Professor |
| Affiliation |
Department of Neurophysiotherapy,Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, Maharashtra, India |
| Address |
Department of Neurophysiotherapy,Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, Mahrashtra, India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9284834850 |
| Fax |
|
| Email |
nishigandha.deodhe@dmiher.edu.in |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy college, Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, Maharashtra, India.
Pincode - 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of higher education and research |
| Address |
Department of Neurophysiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha. |
| 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 Nishigandha Deodhe |
Acharya Vinoba Bhave Hospital |
Department of Neurophysiotherapy,Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA |
09284834850
nishigandha.deodhe@dmiher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research,Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional gait training |
Training was performed in a closed environment and consisted
of routine exercises with controlled intensity. For such, hula hoops, cones, steps, balls, colored
obstacles, horizontal ladders and stairs were used. To execute the tasks, the participants walked
past and/or around obstacles, went up and down a step, performed gait controlled by horizontal
markings on the floor and pace controlled by the therapist’s instructions. The individuals participated in 20-minute training sessions three times a week for six weeks |
| Intervention |
Virtual reality training |
The participant stood two to three meters in front of
the motion sensor of the Kinect Xbox 360TM (Microsoft Corporation, Redmond, WA, USA). The
multimedia projector projected the game Your Shape – Fitness Evolved 2012 – Run the World.
This game was chosen based on its potential to stimulate motor coordination and improve physical
fitness. The participant simulated walking or running by liftingthe knees in a stationary march,
which resulted in a constant displacement of the center of gravity, involving symmetry, alternating
actions and rhythm, which are essential to gait
The individuals participated in 20-minute training sessions three times a week for six weeks |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients with parkinsons diasease who have gait disturbances but walk independently 10 meters |
|
| ExclusionCriteria |
| Details |
Any other neurological, orthopedic, cardiorespiratory condition |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Spatial and temporal parameters of gait |
baseline, after 6 weeks post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
10/06/2026 |
| 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)
|
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
|
This randomized controlled trail aims to compare the effect of virtual reality training versus conventional training on gait parameters in Parkinson’s disease patient using motion analysis (XSENS). Need for the Study: PD leads to significant gait disturbances such as reduced step length, shuffling gait, and decreased walking speed, increasing fall risk and lowering quality of life. Conventional physiotherapy improves mobility but lacks engagement and customization. VR offers immersive, interactive environments that enhance motivation, motor learning, and rehabilitation outcomes. Despite promising findings, more well-designed studies are needed to confirm VR’s effectiveness in PD gait rehabilitation. Study Design - Type: Randomized Controlled Trial (RCT)
- Population: PD patients (50-80 years, Hoehn & Yahr stages I-III)
- Sample Size: 15 participants per group
- Intervention:
- VR Group (A): Kinect Xbox 360™ training with immersive gait tasks
- Conventional Group (B): Traditional gait exercises using cones, obstacles, and therapist-guided activities
- Duration: 6 weeks (3 sessions/week, 20 minutes/session)
- Outcome Measures: Spatial and temporal gait parameters
|