| CTRI Number |
CTRI/2025/07/090486 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/11/2025 |
| 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
|
Study to Find Out if Virtual Reality Exercises Can Help People Move Their Shoulders Better After an Injury |
|
Scientific Title of Study
|
Effect of Virtual reality based exercise protocol on scapular orientation in post traumatic shoulder injuries: 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 |
Sphurti Shamrao Bhoite |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Floor 3, room no 1, Msk department, Dr D Y patil college of physiotherapy, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8850390816 |
| Fax |
|
| Email |
sphurtibhoite25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tushar J Palekar |
| Designation |
Principal |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy. |
| Address |
Department of Musculoskeletal sciences and Hand Conditions, Dr D Y Patil college of physiotherapy, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9822606869 |
| Fax |
|
| Email |
Principal.physio@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sphurti Shamrao Bhoite |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Floor 3, room no 1, Msk department, Dr D Y patil college of physiotherapy, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8850390816 |
| Fax |
|
| Email |
sphurtibhoite25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil College of Physiotherapy,
Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018 |
|
|
Primary Sponsor
|
| Name |
Sphurti S Bhoite |
| Address |
Dr. D. Y. Patil College of Physiotherapy,
Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018 |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 Sphurti S Bhoite |
Dr. D. Y. Patil College of Physiotherapy |
Out Patient Department Dr. D. Y. Patil College of Physiotherapy Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA |
8850390816
sphurtibhoite25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S499||Unspecified injury of shoulder andupper arm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP A CONVENTIONAL AND VIRTUAL REALITY PROGRAM |
General Session Format for All Weeks:
Moist Heat Pack: 10 minutes at the beginning of each session.
VR Session Duration: 15 minutes in each session.
Week 1
Exercises:
Pendulum Exercises (Codmans): 3 sets of 10 reps per direction
Scapular Retraction: 3 sets of 15 reps
Isometric Shoulder Flexion/Extension: 3 sets of 10 reps per direction
VR Module:
Virtual Rehab (Shoulder ROM Training) – 15 minutes
Week 2
Exercises:
Scapular Push-ups: 3 sets of 10 reps
Wall Angels: 3 sets of 10 reps
Shoulder Flexion/Extension with Resistance Bands: 3 sets of 12 reps
VR Module:
Shoulder Motion Challenge – 15 minutes
Week 3
Exercises:
Serratus Anterior Punches: 3 sets of 15 reps
Shoulder External Rotation with Bands: 3 sets of 12 reps
Prone Y & T Raises: 3 sets of 12 reps
VR Module:
VR Scapular Stabilization – 15 minutes
Week 4
Exercises:
Scapular Clock Exercise: 3 sets of 10 reps per direction
Dynamic Hug: 3 sets of 12 reps
Shoulder Flexion/Abduction with Weights: 3 sets of 10 reps
VR Module:
Virtual Rehab (Shoulder ROM Training) – 15 minutes (repeated from Week 1) |
| Comparator Agent |
GROUP B CONVENTIONAL PROGRAM |
General Instructions:
Moist Heat Pack: Applied at the start of each session for 10 minutes
Session Frequency: 2 sessions per week
Total Duration: 4 weeks
Week 1:
Pendulum Exercises (Codman’s)
3 sets of 10 repetitions per direction
Scapular Retraction
3 sets of 15 repetitions
Isometric Shoulder Flexion and Extension
3 sets of 10 repetitions per direction
Week 2:
Scapular Push-ups
3 sets of 10 repetitions
Wall Angels
3 sets of 10 repetitions
Shoulder Flexion/Extension with Resistance Bands
3 sets of 12 repetitions
Week 3:
Serratus Anterior Punches
3 sets of 15 repetitions
Shoulder External Rotation with Resistance Bands
3 sets of 12 repetitions
Prone Y & T Raises
3 sets of 12 repetitions
Week 4:
Scapular Clock Exercise
3 sets of 10 repetitions per direction
Dynamic Hug
3 sets of 12 repetitions
Shoulder Flexion/Abduction with Weights
3 sets of 10 repetitions
Each session includes:
10 minutes: Moist heat application (start of session)
30–40 minutes: Exercise therapy (3 exercises per session)
Total per session: Approximately 40–50 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1 Post three months fracture (Proximal Humerus, acromial joint) Age 18 to 30
2 Both Male and Female Rotator cuff pathology
3 Conservatively managed shoulder dislocation |
|
| ExclusionCriteria |
| Details |
1 Systemic disease
2 Previous shoulder surgery
3 Neurological impairments
4 Cognitive impairments |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pro 360 Inclinometer
Shoulder Pain and Disability Index (SPADI)
Visual Analogue Scale (VAS)
Universal Goniometer |
baseline assessment and post intervention assessment after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
18/07/2025 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
This randomized controlled trial aims to evaluate the effect of combining virtual reality with conventional physiotherapy on scapular orientation in individuals with post-traumatic shoulder injuries. The study will involve a total of 60 participants, aged between 18 to 30 years, who have sustained shoulder injuries such as proximal humerus or acromioclavicular joint fractures (post three months), conservatively managed shoulder dislocations, or rotator cuff pathologies. Participants will be randomly allocated into two groups of 30 each using a computer-generated randomization method. Group A will receive conventional therapy alone, which includes a structured four-week physiotherapy program comprising pendulum exercises, scapular retraction, isometric exercises, scapular push-ups, wall angels, resistance band exercises, serratus anterior punches, prone Y & T raises, scapular clock, dynamic hug, and ROM training with weights. Each participant will undergo two sessions per week, for a total of eight sessions over four weeks. Each session will include a 10-minute moist heat pack application at the start, followed by 30–40 minutes of exercise therapy. Group B will receive conventional therapy combined with virtual reality-based rehabilitation. In addition to the conventional exercises, participants in this group will engage in 15-minute VR sessions using the Oculus Quest 2 headset, involving interactive programs such as Virtual Rehab (shoulder ROM training), Shoulder Motion Challenge, and VR Scapular Stabilization modules. These sessions aim to enhance patient engagement, motor learning, and adherence to therapy. The primary outcome measures Pain assessed using the Visual Analogue Scale (VAS), shoulder function assessed via the Shoulder Pain and Disability Index (SPADI), and range of motion measured using a goniometer. The trial will follow a single-blinded design, where the outcome assessor is blinded to group allocation. The study will be conducted at the Outpatient Department of Dr. D.Y. Patil College of Physiotherapy, Pune. This research aims to contribute to developing more effective and engaging rehabilitation strategies for post-traumatic shoulder injury patients by integrating virtual reality into traditional physiotherapeutic protocols. |