| CTRI Number |
CTRI/2024/06/068976 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
comparison of muscle strength, power, flexibility , physical fitness parameters and quality of life in different Para athletes. |
|
Scientific Title of Study
|
Comparison of physicat Fitness, Bio motor skills and Quality of Life
in para- athletes with Upper limb involvement and Lower Limb involvement |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Falak Oza |
| Designation |
Assistant Proffesor in Physiotherapy |
| Affiliation |
U.N.Mehta Institute of cardiology and Research Center,Ahmedabad. PhD Scholar at RK University |
| Address |
6,Sanskruti Apartment,
(2nd floor),Opposite Goodluck Hall,
Daxini Society,Maninagar,Ahmedabad
Ahmadabad
GUJARAT
380008
India |
| Phone |
9723958815 |
| Fax |
|
| Email |
falakoza_35@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Falak Oza |
| Designation |
Assistant Proffesor in Physiotherapy |
| Affiliation |
U.N.Mehta Institute of cardiology and Research Center,Ahmedabad. PhD Scholar at RK University |
| Address |
6,Sanskruti Apartment,
(2nd floor),Opposite Goodluck Hall,
DAxini Society,Maninagar,AHmedabad
Ahmadabad
GUJARAT
380008
India |
| Phone |
9723958815 |
| Fax |
|
| Email |
falakoza_35@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Falak Oza |
| Designation |
Assistant Proffesor in Physiotherapy |
| Affiliation |
U.N.Mehta Institute of cardiology and Research Center,Ahmedabad. PhD Scholar at RK University |
| Address |
6,Sanskruti Apartment,
(2nd floor),Opposite Goodluck Hall,
DAxini Society,Maninagar,AHmedabad
Ahmadabad
GUJARAT
380008
India |
| Phone |
9723958815 |
| Fax |
|
| Email |
falakoza_35@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Para Sports Association of Gujarat.
The SOciety for Physically Handicapped Ahmedabad,
PAvandham HOstel
Sandesh Press Road, Bodakdev, AHmedabad- 380054
Gujarat
India
for recruitment of Para Athletes
Near Sandesh Press,Vastrapur ,Ahmedabad, Gujarat |
| Sports Authority of Gujarat,
administrative block, Sector 13B, Kh-3 circle, near vavol crossing
Gandhinagar, Gujarat , India.- 382016 |
|
|
Primary Sponsor
|
| Name |
Dr Falak Oza |
| Address |
20 Gaurang APartment, NEar DAxini Society,Maninagar
Ahmedabad- 380008
Gujarat,Inida |
| Type of Sponsor |
Other [Self Sponsered] |
|
|
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 |
| MR GAURAV PARIKH |
Para Sports Association of Gujarat |
Pavandham Hostel,
GRound Floor,
Bodakdev, AHmedabad- 380054
Ahmadabad
GUJARAT |
8758147147
falakoza_35@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, School of Physiotherapy, RK University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PARA ATHLETES |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Physical Fitness and Biomotor SKills |
These factors to be compared in para athletes with either upper body or lower body involvment to design better training plans for them and to have a baseline data of indian para athletes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Para athletes with upper and lower limb involvement.
Those who are willing to participate |
|
| ExclusionCriteria |
| Details |
Para-athletes with intellectual deficits will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Physical fitness
Biomotor skills like Muscle stregnth , Endurance , Power, Flexibity and aerobic power.
|
At Baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life by WHoQOL quetionnaire |
at Baseline |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
23/06/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study comapares Physical fitness ,biomotor skills and quality of life in para athletes who have upper limb and lower limb involvement. subjects will be recruited from gujarat state and from para sports associaltion of gujarat. they will be divided intoac upper and lower body group based on their disability. all will be tested for physical fitness component with their disability specific tests and quality of life will be obtained through WHO-QoL quetionnaire.
|