| CTRI Number |
CTRI/2025/08/093019 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Using virtual reality exercise games versus to regular physiotherapy for frozen shoulder a study on movement fear of pain and sticking with treatment |
|
Scientific Title of Study
|
Effects of virtual reality exergaming to conventional physiotherapy in stage II frozen shoulder on functional activity, kinesiophobia and adherence : 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 |
Anmol Dodani |
| Designation |
Post graduate student |
| Affiliation |
Dr. DY Patil College of Physiotherapy |
| Address |
3rd floor, Musculoskeletal department, Dr. DY Patil College of Physiotherapy, Sant tukaram nagar, Pimpri, Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9373548523 |
| Fax |
|
| Email |
dodanianmol44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa Desai |
| Designation |
Professor |
| Affiliation |
Dr. D.Y Patil college of Physiotherapy |
| Address |
3rd floor, Musculoskeletal department, Dr. DY Patil College of Physiotherapy, Sant tukaram nagar, Pimpri, Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9890992383 |
| Fax |
|
| Email |
roopa.desai@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Anmol Dodani |
| Designation |
Post graduate student |
| Affiliation |
Dr. D.Y Patil college of Physiotherapy |
| Address |
3rd floor, Musculoskeletal department, Dr. DY Patil College of Physiotherapy, Sant tukaram nagar, Pimpri, Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9373548523 |
| Fax |
|
| Email |
dodanianmol44@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y. Patil College of Physiotherapy, Pimpri, Pune, Maharashtra, India 411018 |
|
|
Primary Sponsor
|
| Name |
Dr.Dy Patil college of physiotherapy Pimpri Pune |
| Address |
3rd floor, Musculoskeletal department, Dr. DY Patil College of Physiotherapy, Sant tukaram nagar, Pimpri, Pune 411018 |
| 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 Anmol Dodani |
Dr. D.Y. Patil College of Physiotherapy, Pimpri, Pune 411018 |
Dr. D. Y Patil college of Physiotherapy OPD, MSK DEPT. ROOM NO 1 Ground floor , Pimpri, Pune MAHARASHTRA
Pune
MAHARASHTRA |
9373548523
dodanianmol44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee meeting |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparing the effects of VR to conventional physiotherapy for stage II frozen shoulder |
Comparing the effects of Virtual Reality Exergaming to Conventional Physiotherapy for the population with stage II Frozen Shoulder, for the duration of 4 weeks. |
| Intervention |
experimental study |
STUDY DESIGN- An experimental study
STUDY SETTING-Dr. D.Y.Patil college of physiotherapy
TARGET POPULATION-Patients diagnosed with phase 2 frozen
shoulder
SAMPLE POPULATION-Individuals aged 40-60 years with confirmed phase 2 frozen
shoulder
SAMPLING METHOD Simple random
sampling
SAMPLE SIZE-57
SAMPLE DESIGN Two groups one receiving conventional physiotherapy with functional activities and the other receiving VR
exergaming with conventional
physiotherapy. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with stage 2 frozen shoulder (confirmed through clinical evaluation).
No previous surgical interventions for frozen
shoulder.
Willing to participate in both conventional physiotherapy and VR
exergaming.
Able to provide informed consent.
Mild to moderate pain on NPRS |
|
| ExclusionCriteria |
| Details |
Previous shoulder surgeries or fractures.
Diagnosed with severe neurological or other musculoskeletal disorders
affecting shoulder movement.
Cognitive impairments preventing use of VR
exergaming.
Uncontrolled medical conditions like diabetes or cardiovascular disease.
Those with balance issues or vestibular disorders
Patients with severe visual problems
Individuals with cognitive issues
Patients with Severe Mobility Restrictions in shoulder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Functional ability SPADI
2 Kinesiophobia TAMPA Scale
3 Adherence Adherence rate |
at baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain - assessed using the Numeric pain rating scale, which measures pain intensity
Range of motion -measured be using Goniometer |
at the baseline and the end of 4 week intervention |
|
|
Target Sample Size
|
Total Sample Size="57"
Sample Size from India="57"
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)
|
25/08/2025 |
| 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="6"
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 study explores the effectiveness of combining Virtual Reality VR exergaming with conventional physiotherapy in managing Stage II frozen shoulder also known as adhesive capsulitis. Frozen shoulder is a condition characterized by pain and restricted movement, especially common among adults aged 40–60. This experimental study with sample size of 57 participants divided into two groups one receiving VR exergaming with conventional therapy and the other receiving only functional activities with conventional therapy. Over four weeks the study assessed outcomes such as functional ability by SPADI kinesiophobia using Tampa Scale and adherence to therapy. Pain levels using NPRS and shoulder range of motion using goniometry. The rationale behind the study is that immersive VR can improve patient engagement and adherence potentially leading to better rehabilitation outcomes. The presentation highlights the need for more research on VR’s role in musculoskeletal rehabilitation as it is currently more common in neurological conditions. |