| CTRI Number |
CTRI/2024/07/070333 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Joint Hypermobility and musculoskeletal pain |
|
Scientific Title of Study
|
Association and Strategies to manage musculoskeletal pain in Hypermobile childrens in Moodbidri. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KSHAMA SUSHEEL SHETTY |
| Designation |
PhD Scholar |
| Affiliation |
Alvas College of Physiotherapy and Research Centre |
| Address |
Alvas Health Center Complex,
Department of Physiotherapy
Alvas College of Physiotherapy and Research Centre, Moodbidri
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9591593863 |
| Fax |
|
| Email |
poonjakshama@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hariharasudhan Ravichandran |
| Designation |
Professor |
| Affiliation |
Alvas College of Physiotherapy and Research Centre |
| Address |
Moodbidri
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9789906015 |
| Fax |
|
| Email |
hrkums63@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KSHAMA SUSHEEL SHETTY |
| Designation |
PhD Scholar |
| Affiliation |
Alvas College of Physiotherapy and Research Centre |
| Address |
Alvas Health Center complex, Department of Physiotherapy, Alvas College of Physiotherapy and Research Centre, Moodbidri
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9591593863 |
| Fax |
|
| Email |
poonjakshama@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas COllege of Physiotherapy and Research Centre, Department of Physiotherapy, Alvas Health Center complex, Moodbidri |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [No Sponsor] |
|
|
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 |
| Kshama Susheel Shetty |
Schools in Moodbidri town |
Rotary english medium School, Moodbidri
Dakshina Kannada
KARNATAKA |
9591593863
poonjakshama@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD OF ALVAS COLLEGE OF PHYSIOTHERAPY AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hypermobility Joint |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exercises
Balance training |
Proprioception exercises
Joint stabilisation exercises
frequency: 3 times per week
total duration: 6 weeks |
| Comparator Agent |
Exercises |
Balance exercise
Proprioception exercises
Frequency: 3 times / week
Duration: 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Childrens with hypermobility
Parents consent for childs participation |
|
| ExclusionCriteria |
| Details |
Non hypermobile children
Not willing to participate
Not having musculoskeletal pain complains according to Nordic pain questionnaire |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Musculoskeletal pain |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
AIM
·
To identify the impact of hypermobility in
musculoskeletal system in pre-adolescent children
OBECTIVES
General objectives
·
The main focus of this study is to analyse
the onset, distribution and extent of musculoskeletal disorders among
pre-adolescent children with joint hypermobility.
Specific objectives
·
To identify the prevalence and the factors
that associated with joint hypermobility syndrome among pre-adolescent children
·
To develop and validate a musculoskeletal
disorder questionnaire to utilise among pre-adolescent children with
hypermobility
·
To analyse the relationship between joint
hypermobility and musculoskeletal pain among pre-adolescent children
·
To identify the common sites of
musculoskeletal pain among preadolescent children with joint hypermobility.
RESEARCH QUESTION
Primary research question
What
are the effects of joint hypermobility syndrome in musculoskeletal system of
preadolescent children in Moodbidri town, Dakshina Kannada Taluk, Karnataka
Research
question of individual studies
1. What
is the prevalence and the factors that are associated with joint hypermobility
syndrome among pre-adolescent children’s?
2. Which
musculoskeletal questionnaire shall be implemented to identify musculoskeletal
issues among pre-adolescent children with joint hypermobility syndrome
3. Is
there any relationship exists between joint hypermobility syndrome and musculoskeletal
pain among pre-adolescent children
4. What
are the common sites of musculoskeletal pain among pre-adolescent children with
joint hypermobility syndrome
To
answer these research questions four studies will be performed
1. Prevalence
and factors associated with hypermobility syndrome among pre-adolescent
children in Moodbidri town, Dakshina Kannada taluk, Karnataka
2. Development
and validation of a musculoskeletal pain questionnaire to implement among
pre-adolescent children in Moodbidri town, Dakshina Kannada taluk, Karnataka
3. Relationship
between joint hypermobility and musculoskeletal pain among pre-adolescent
children in Moodbidri town, Dakshina Kannada taluk, Karnataka
4. Common
sites of musculoskeletal pain among pre-adolescent children with hypermobility
in Moodbidri town, Dakshina Kannada taluk, Karnataka.
|