| CTRI Number |
CTRI/2023/06/054305 [Registered on: 22/06/2023] Trial Registered Prospectively |
| Last Modified On: |
21/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Balance and Muscle Power in Children with β-Thalassemia: A Case Control Study |
|
Scientific Title of Study
|
Balance and Muscle Power in Children with β-Thalassemia: A Case Control Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepa Metgud |
| Designation |
Dean and Head of Department of Pediatric Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy
Department of Pediatric Physiotherapy
JNMC Campus
Nehru Nagar
Belgaum
Belgaum
Karnataka
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9845861236 |
| Fax |
|
| Email |
drdeepa_metgud@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Metgud |
| Designation |
Professor Dean and Head of Department of Pediatric Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy
Department of Pediatric Physiotherapy
JNMC Campus
Nehru Nagar
Belgaum
Belgaum
Karnataka
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9845861236 |
| Fax |
|
| Email |
drdeepa_metgud@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Revati chavan |
| Designation |
Postgraduate student |
| Affiliation |
KLE Institute of Physiotherapy Belgaum |
| Address |
Advanced Physiotherapy Centre, Department of Pediatric Physiotherapy, Room no 39, Sagar Floor, Belgaum Karnataka 590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
revashruti@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr.Prabhakar Kore Hospital And Research Centre
Nehru Nagar Belgavi
|
|
|
Primary Sponsor
|
| Name |
KAHER Institute Of Physiotherapy |
| Address |
KAHER Institute Of Physiotherapy JNMC Campus, Nehru Nagar,
Belgavi |
| 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 |
| Dr Deepa Metgud |
KAHER Institute of Physiotherapy |
Advanced physiotherapy centre , room no 39,Sagar Floor, KLE DR PrabhakarKpre Hospital Belgaum Karnataka590010 India
Belgaum
KARNATAKA |
9845861236
drdeepa_metgud@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific and ethics committee KAHER Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D70-D77||Other disorders of blood and blood-forming organs, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
children diagnosed with β-Thalassemia
Both Male and Female
Age between 8-14 year
Parent and children willingness to participate |
|
| ExclusionCriteria |
| Details |
Unstable hemodynamic parameters
Orthopedic deformities or soft tissue injury
Surgical History <6 months
Visual and auditory impairments
Neurological conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bruininks Oseretsky test for evaluating Balance |
After the CTRI registration the data will be collected |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vertical Jump test for evaluating Muscle power |
After the CTRI registration the data will be collected |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
01/07/2023 |
| 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
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Individuals with β Thalassemia suffer from different comorbities such as fatigue, cardiomyopathy, body pain, Diabetes, Low bone mass, sedentary lifestyle, osteoporosis, depression and anxiety. Sedentary behaviour is thought to be an aggravating factor which contributes to physical and muscle deconditioning .Due to diminished activities or some other underlying cause balance and muscle power might get impaired. Because its vital and relatively silent nature less literature has ben conducted on these components. Therefore the present study aims in assessing balance and muscle power in children with β Thalassemia. |