| CTRI Number |
CTRI/2024/08/072644 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
15/08/2024 |
| 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
|
Additive Effect of IVR Program on Pain, Function, and Kinesiophobia in patients with Frozen Shoulder |
|
Scientific Title of Study
|
Additive Effect Of Immersive Virtual Reality Program Along With Conventional exercise On Pain, Function, and Kinesiophobia in Patients with Frozen Shoulder: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Heti Jadav |
| Designation |
Masters Of Physiotherapy Student |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Department of Physiotherapy, Institute of Physiotherapy, Srinivas University, Pandeshwar Campus, Dakshina Kannada, Karnataka 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
09924638398 |
| Fax |
|
| Email |
hetijadav2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Kamalakannan |
| Designation |
Associate Professor |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Department of Physiotherapy, Institute of Physiotherapy, Srinivas University, Pandeshwar Campus, Dakshina Kannada, Karnataka 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9924638398 |
| Fax |
|
| Email |
kamalakannan.pt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Heti Jadav |
| Designation |
Masters Of Physiotherapy Student |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Department of Physiotherapy, Institute of Physiotherapy, Srinivas University, Pandeshwar Campus, Dakshina Kannada, Karnataka 575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
09924638398 |
| Fax |
|
| Email |
hetijadav2@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Heti Jadav |
| Address |
Department of Physiotherapy, Institute of Physiotherapy, Srinivas University, Pandeshwar Campus, Dakshina Kannada, Karnataka 575001 |
| 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 |
| Heti Jadav |
Musculoskeletal OPD, Institute of Physiotherapy |
Department of Physiotherapy, Institute of Physiotherapy, Srinivas University, Pandeshwar Campus, Dakshina Kannada, Karnataka 575001
Dakshina Kannada
KARNATAKA |
09924638398
hetijadav2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Srinivas University Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M256||Stiffness of joint, not elsewhereclassified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Exercise |
Conventional exercise session will consist of 10 repetitions 3 sets/session of each exercise and will last 30-45 minutes. The exercise will be performed for 3 days/week for 4 weeks. |
| Intervention |
Immersive Virtual Reality + Conventional Exercise |
The IVR + Conventional exercise will be used for the study. Each exercise session will include 15 repetitions, involving 15 minutes of IVR and 30 minutes of conventional exercise, and be conducted for 6 weeks, with participating in the exercise 3 days/week. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed Frozen shoulder patients with Stage 2 and 3, where stiffness is more than pain.
NPRS would be between 3 to 7 out of 10.
Restriction of PROM would be more than 50% in abduction, flexion, and external rotation.
Tampa Scale of Kinesiophobia-11 will be more than 23. |
|
| ExclusionCriteria |
| Details |
Proximal humerus fracture to the affected shoulder.
Rotator cuff tear.
Subacromial bursitis.
Rheumatoid Arthritis of the shoulder.
Cervicogenic shoulder pain.
Pseudo-frozen shoulder.
Locked posterior shoulder dislocation.
Proximal humerusbony tumor.
People who received additional pain management procedures, such as intra-articular injection during the therapy.
Surgical intervention on the affected shoulder for 6 months.
Unhealed scar around the shoulder. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Shoulder Pain and Disability Index (SPADI) |
Baseline, 6th week, 12th week, 24th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numeric Pain Rating Scale (NPRS) |
Baseline, 6th week, 12th week, 24th week |
| TAMPA Scale of Kinesiophobia (TSK-11) |
Baseline, 6th week, 12th week, 24th week |
| Universal Goniometer measurement |
Baseline, 6th week, 12th week, 24th week |
| Hand behind-back measurement |
Baseline, 6th week, 12th week, 24th week |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/08/2024 |
| 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 Applicable |
| 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 document outlines a research proposal for a randomized controlled trial to study the additive effect of immersive virtual reality (IVR) programs combined with conventional exercises on patients with frozen shoulder. Here are the key points:
1. Study Design: Randomized controlled trial with two groups - experimental (IVR + conventional exercises) and control (conventional exercises only).
2. Population: Patients diagnosed with frozen shoulder, aged 40-60 years.
3. Sample Size: 18 participants per group, with a 20% dropout allowance.
4. Duration: 6 weeks of intervention, with follow-ups at 12 and 24 weeks.
5. Intervention: - Experimental group: IVR exercises + conventional exercises - Control group: Conventional exercises only
6. Outcome Measures: - Primary: Shoulder Pain and Disability Index (SPADI) - Secondary: Numerical Pain Rating Scale (NPRS), Tampa Scale of Kinesiophobia (TSK-11), Range of Motion (ROM) measurements
7. IVR Program: Three phases over 6 weeks, including exercises like penguin picking, fruit catch, and boxing simulations.
8. Conventional Exercises: Include active ROM exercises, stretching, joint mobilization, and strengthening exercises.
9. Statistical Analysis: Will use SPSS software for data analysis, including tests for normality and appropriate parametric or non-parametric tests.
10. Ethical Considerations: Informed consent, confidentiality, and right to withdraw are addressed.
The study aims to provide evidence on the efficacy of immersive virtual reality in treating frozen shoulder, specifically its effects on pain, function, and kinesiophobia, with long-term follow-up. |