| CTRI Number |
CTRI/2023/10/059276 [Registered on: 30/10/2023] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Closed Kinetic Chain exercise via Telerehabilitation in Beta Thalassemia Major children |
|
Scientific Title of Study
|
Effect of Closed Kinetic Chain exercise via Telerehabilitation on Muscle strength, Balance, Fatigue and Hemoglobin levels in Beta Thalassemia Major children: A Randomized Control 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 |
Revati Chavan |
| Designation |
Post Graduate |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Sagar Floor, Advanced Physiotherapy Centre, Room no 39, KLE
Dr.Prabhakar Kore Hospital and MRC, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9920564788 |
| Fax |
|
| Email |
revashruti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Metgud |
| Designation |
Dean and Head of Department of pediatric Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Sagar Floor, Advanced Physiotherapy Centre, Room no 39, KLE
Dr.Prabhakar Kore Hospital and MRC, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9845861236 |
| Fax |
|
| Email |
drdeepa_metgud@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Revati Chavan |
| Designation |
Post Graduate |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Sagar Floor, Advanced Physiotherapy Centre, Room no 39, KLE
Dr.Prabhakar Kore Hospital and MRC, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9920564788 |
| Fax |
|
| Email |
revashruti@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr. Prabhakar Kore Hospital and Research Centre, Nehru Nagar, Belagavi |
|
|
Primary Sponsor
|
| Name |
Revati Chavan |
| Address |
Sagar Floor, Advanced Physiotherapy Centre, Room no 39, KLE
Dr.Prabhakar Kore Hospital and MRC, Belagavi,Karnataka, 590010 |
| Type of Sponsor |
Other [Self Sponsored] |
|
|
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 |
| Revati Chavan |
KAHER Institute of Physiotherapy |
Advanced Physiotherapy Centre, Room no.39, Sagar floor, KLE Dr Prabhakar Kore Hospital ,Belgaum
Belgaum
KARNATAKA |
9920564788
revashruti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Comittee KAHER Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D561||Beta thalassemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Closed kinetic chain exercises |
Warm up -Walking , Jogging, Stretching - 5-10 min Hel Raises,Lunges, Wall Squats Pelvic Bridging,Quadricep Setting,Forward Step up . All these exercises were performed for 2 weeks with1 set of 8 repitations progressing in 3rd week with 2 set 8 repitations From 5th week Heel raises with knee flexion, In line Lunge Deep Squats, Unilateral Bridging, Terminal Knee Extension, Forward Step up (6 inch) All these exercises were performed for 1 set with 8 repitations progressing it in the 7th week with 2 set of 8repitations. Cool down exercises such as breathing exercises were performed after every session
Duration : 8 Weeks |
| Comparator Agent |
Control Group |
The control group will receive education about importance being physically active and to continue their routine activities
Duration: 8 weeks
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children diagnosed with beta thalassemia major
Both male and female children in the age group of 8-15
Parents having video call communicable device with internet
Parents willing to monitor the children during the exercise training
Children and Parents willing to participate
|
|
| ExclusionCriteria |
| Details |
• Unstable Hemodynamic Parameters
Unstable Cardiovascular Disease and on medications for the same
Orthopedic deformity or recent fracture
Neurological Dysfunction
Severe respiratory infection
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Hand held dynamometer for muscle strength
2.BOT-2 for Balance
|
T0 baseline
T1 - At 4 weeks
T2 - post intervention(8weeks) ()
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Fatigue by Pediatric Quality of Life Inventory Multidimensional Fatigue Scale
(PedsQL-MFS)
2. Hemoglobin levels |
T0 baseline
T1 - At 4 weeks
T2 - post intervention(8weeks) |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/11/2023 |
| Date of Study Completion (India) |
15/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Children with thalassemia are known to be less physically active than their peers which contributes to physical and muscle deconditioning in these patients. This deconditioning again leads to physical inactivity and the viscous cycle continues. Also, they have chronic joint pain due to low bone mass. Several literatures have documented that poor balance performance has been linked to osteoporosis or sarcopenia which Is seen in beta thalassemic children and is highly suggestive of positive correlation between them . It is known from various literature that these children also have reduced muscle strength, flexibility, and low quality of life. As children in this age group are highly active, a strong powerful musculature is needed to meet those demands So, a strengthening protocol might be effective in improving the strength and balance in these children and eventually reducing the risk of falls . Hence the need arises to study the effects of closed kinetic chain exercises via telerehabilitation on muscle strength, balance, fatigue and hemoglobin levels in beta thalassemia major children. |