| CTRI Number |
CTRI/2024/12/078340 [Registered on: 19/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Video assisted Physiotherapy for children with arthritis |
|
Scientific Title of Study
|
Effect of Video assisted Physiotherapy on compliance and functional ability in patients with JIA: 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 |
Dr Sumita Gupta |
| Designation |
Superintendent Physiotherapist |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 526, Physiotherapy Room, Dept. of Pediatrics, Mother and Child Block, AIIMS. New Delhi
South West
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
sumitabisoi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumita Gupta |
| Designation |
Superintendent Physiotherapist |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 526, Physiotherapy Room, Dept. of Pediatrics, Mother and Child Block, AIIMS. New Delhi
South West
DELHI
110029
India |
| Phone |
9810147877 |
| Fax |
|
| Email |
sumitabisoi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumita Gupta |
| Designation |
Superintendent Physiotherapist |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 526, Physiotherapy Room, Dept. of Pediatrics, Mother and Child Block, AIIMS. New Delhi
South West
DELHI
110029
India |
| Phone |
9810147877 |
| Fax |
|
| Email |
sumitabisoi@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, Ansari Nagar East, New Delhi 110029, India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sumita Gupta |
AIIMS |
Room No. 526, Physiotherapy Room, Dept. of Pediatrics, Mother and Child Block, AIIMS, Ansari Nagar East, New Delhi
South West
DELHI |
9810147877
sumitabisoi@gmail.com |
| Ms Roshni Sinha |
AIIMS, New Delhi |
Room No. 52, Physiotherapy Room,Dept. of Pediatrics, Mother and Child Block, AIIMS,Ansari Nagar East, New Delhi
South West
DELHI |
8076380445
roshnisinha@aiims.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M089||Juvenile arthritis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine physiotherapy protocol |
Routine physiotherapy exercises are provided to control group for 9 months. |
| Intervention |
Videos of exercises along with routine physiotherapy exercises |
Videos of exercises are given to intervention group to see its effect on compliance for 9months |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with JIA |
|
| ExclusionCriteria |
| Details |
1. Non availability of a smart phone/ video capturing device/ internet service
2. Active arthritis within last 15 days
3. Pre-existing deformity of more than 2 joints |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compliance rate |
end of 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| functional ability |
end of 9 months |
| Technique of exercises |
after every 3 months for the period of study |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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)
|
30/12/2024 |
| 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="2"
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
|
JIA patients typically have follow-ups every three months in the Pediatric Rheumatology Clinic (PRC), making it difficult to assess the compliance to exercise protocol more frequently. This limits direct observation and reinforcement of physiotherapy techniques. To address these challenges, this study explores the use of exercise videos that could mimic direct observation of physiotherapy. This study focuses on compliance to physiotherapy protocol using smartphone/mobile based exercise videos compared to compliance with standard home based exercise protocol. All patients visiting the outpatient department/Pediatric Rheumatology Clinic with diagnosis of JIA, fulfilling the inclusion criteria will be enrolled in the study after proper information and obtaining informed consent from the parents/legally authorized representative (LAR). Assent will be obtained from children >7 years of age. Patients will be divided into two groups: Intervention group (video assisted and routine physiotherapy) and Control group (routine physiotherapy). Children randomized to intervention group will be taught routine physiotherapy for the affected joints along with which videos of the same will be provided to them. They will be asked to send videos of the exercises daily for the first 7 days. The videos will be assessed by an assessor. If more than 80% steps are performed correctly according to the check-list, then it will be rated as correct. If the technique is found to be inappropriate it will be corrected on the same day by telephonic call or video call. In case the participant fails to send the videos for 2 consecutive days in the initial 7 days, he/she will be reminded telephonically for the same. After 7 days, participants will send the videos once a week for the next 3 weeks of the first month and then once a month for the remaining 8 months. The patient will be assessed by the two assessors (one of which being an independent assessor) after every 3 months, 6 months and 9 months for the correctness of the technique. They will be reviewed for the functional ability at the end of the study. Children randomized to control group will continue physiotherapy as usual and be followed up in Pediatric Rheumatology clinic every 3 monthly for 9 months. They would be assessed for correctness of technique and functional ability. Both the groups will be provided with a diary to record the number of times exercises performed and duration of their daily physiotherapy sessions. |