| CTRI Number |
CTRI/2023/10/058910 [Registered on: 19/10/2023] Trial Registered Prospectively |
| Last Modified On: |
10/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of an exercise program in female
hypermobile gymnasts.
|
|
Scientific Title of Study
|
Effectiveness of an exercise program
on pain, muscle strength,
proprioception, physical fitness and
health related quality of life in female
hypermobile gymnasts.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ishani Sinha |
| Designation |
MPT Sports Student |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak |
| Address |
College of Physiotherapy Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8376867035 |
| Fax |
|
| Email |
ishanisinha8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Dhankhar |
| Designation |
Assistant Professor |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak |
| Address |
College of Physiotherapy Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8607157000 |
| Fax |
|
| Email |
Poonam.physio@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Dhankhar |
| Designation |
Assistant Professor |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak |
| Address |
College of Physiotherapy Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8607157000 |
| Fax |
|
| Email |
Poonam.physio@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| College of Physiotherapy Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak |
|
|
Primary Sponsor
|
| Name |
Ishani Sinha |
| Address |
College of Physiotherapy Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak |
| Type of Sponsor |
Other [self] |
|
|
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 ISHANI SINHA |
PGIMS,Rohtak |
College of Physiotherapy
Rohtak
HARYANA |
8376867035
ishanisinha8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Female Hypermobile gymnasts with knee pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
To study the effect of exercise program on pain, muscle strength, proprioception, physical fitness and health related quality of life in female hypermobile gymnasts.
|
Hypermobility screening will be done first after then 8 week exercise protocol will be followed |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Female |
| Details |
Female Hypermobile gymnasts with knee pain |
|
| ExclusionCriteria |
| Details |
1.Previous knee joint surgery.
2.Subject who is not willing to participate in study.
3.Subject who is suffering from any cognitive difficulty or visual impairment.
4.Subject who is suffering from rheumatological disorders like RA etc.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Beighton Score
2.Pain
3.Proprioceptive acuity
4.Muscle strength
5.Gymnastic functional measurement tool (Permission granted from Authors to use questionnaire)
6.Health related quality of life
|
At 0,4 and 8 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Exercise protocol |
8 week |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
25/10/2023 |
| 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="1"
Months="0"
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
|
Title:- Effectiveness of an exercise program on pain, muscle strength, proprioception, physical fitness and health related quality of life in female hypermobile gymnasts. Inclusion criteria:- 1. Subjects in age group of 8-16 years. 2. Female gymnats 3. Subjects having beighton score more than or equal to 5/9 4. Subjects having knee joint pain Exclusion criteria:- 1. Previous knee joint surgery 2. Subject who is not willing to participate in this study 3. Subject who is suffering from any cognitive difficulty, visual impairement. 4. Subject who are suffering from rheumatological disorders like RA. Sample size- 22 , calculated by previous studies Dependent variables:- 1. Beighton score 2. Muscle strength 3. Proprioceptive acuity 4. Gymnasts functional measurement tool 5. Pain 6. Health related quality of life Independent variables:- Exercise protocol- 8 week Type of Study and study design:- Interventional, Single arm study |