| CTRI Number |
CTRI/2021/12/038984 [Registered on: 28/12/2021] Trial Registered Prospectively |
| Last Modified On: |
25/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFECT OF EXERCISES ON BALANCE IN CHILDREN WITH DIABETES |
|
Scientific Title of Study
|
EFFECT OF PLYOMETRIC EXERCISES ON BALANCE IN CHILDREN WITH JUVENILE DIABETES MELLITUS:A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jadhav Kaustubh Gurudatta |
| Designation |
PG Student |
| Affiliation |
KAHER Institue of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, JNMC Campus, Nehru Nagar, Belgavi
Solapur
Belgaum
KARNATAKA
590010
India |
| Phone |
8999004361 |
| Fax |
|
| Email |
jkaustubh3197@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shukra Chivate |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institue of Physiotherapy |
| Address |
Department of Paediatric Physiotherapy, KAHER Institute of Physiotherapy, JNMC Campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
shukramantganiker@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kaustubh Jadhav |
| Designation |
PG Student |
| Affiliation |
KAHER Institue of Physiotherapy |
| Address |
Department of Paediatric Physiotherapy, KAHER Institute of Physiotherapy, JNMC Campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
jkaustubh3197@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLES Dr. Prabhakar Kore Hospital and Research Centre, Nehru Nagar, Belagavi |
|
|
Primary Sponsor
|
| Name |
KAHER Institute of Physiotherapy |
| Address |
JN Medical College Campus, Nehru Nagar, Belagavi, Karnataka |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Jadhav Kaustubh Gurudatta |
KLES Dr. Prabhakar Kore Hospital |
Department of Paediatric Physiotherapy, KAHER Institute of Physiotherapy, JNMC Campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA |
8999004361
jkaustubh3197@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee (KAHER Institute of Physiotherapy) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E106||Type 1 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Balance exercises |
Conventional balance exercises will be administered to the participants on the basis of childs initial performance. The number of repetitions for first 2 weeks will be set at 50 percentage of estimated repetitions during initial measurement and will be increased to 75 percentage in later 2 weeks |
| Intervention |
Plyometric Exercises |
Plyometric exercises consists of exercises in horizontal as well as vertical models. Each session will last for 45 minutes and will performed by the child 2 times per week for 4 weeks. Each exercise will be given with 5 repetitions for first 2 weeks and progressed to 10 repetitions for the later 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Participants diagnosed with Type-1 Diabetes Mellitus.
Minimum history of 1 year of Type-1 DM.
Participants who are willing to participate and parents allowing to participate. |
|
| ExclusionCriteria |
| Details |
Visual and cognitively impaired.
Recent fractures in last 6 months.
Cardiovascular diseases.
Neurodevelopmental disabilities with balance dysfunction.
Fixed deformities
Children with congenital hearing loss.
Sensory Impairment.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT-2)-Balance Subset
|
Pre-Intervention
Post-Intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pediatric Balance Scale |
Pre-Intervention
Post-Intervention |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
03/01/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of this study is to evaluate the effect of plyometric exercises on balance in children with Juvenile Diabetes Mellitus. The Bruininks-Oseretsky Test for Motor Proficiency, Pediatric Balance Scales will be used as the outcome measures for the pre and post assessment on day 1 and after 4 weeks. |