| CTRI Number |
CTRI/2015/06/005855 [Registered on: 03/06/2015] Trial Registered Retrospectively |
| Last Modified On: |
13/10/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two different types of strengthening exercises for shoulder in competitive overhead athletes for 3 weeks |
|
Scientific Title of Study
|
Comparison Of Open And Closed Kinematic Chain Exercises For SICK Scapula In Competitive Overhead Athletes For 3 weeks- A Randomized Clinical Trial |
| Trial Acronym |
SICK |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neelam J Patel |
| Designation |
MPT Student |
| Affiliation |
KLE University Institute Of Physiotherapy |
| Address |
Type 3A/17/202,
R.C.F Colony, Post Mahul Road,
Chembur, Mumbai, Maharashtra,400074, India
KLE University Institute Of Physiotherapy, JNMC Campus, NehruNagar,Belgaum
KARNATAKA
590010
India
Mumbai
MAHARASHTRA
400074
India |
| Phone |
9916718147 |
| Fax |
08312472777 |
| Email |
neelamp811@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anil R Muragod |
| Designation |
Assistant Professor |
| Affiliation |
KLE University Institute Of Physiotherapy |
| Address |
KLE University Institute Of Physiotherapy, JNMC Campus, NehruNagar, Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
09448334248 |
| Fax |
08312472777 |
| Email |
dranilphysio@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjiv Kumar |
| Designation |
Principal |
| Affiliation |
KLE University Institute Of Physiotherapy |
| Address |
KLE University Institute Of Physiotherapy, JNMC Campus, NehruNagar, Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9448745648 |
| Fax |
08312472777 |
| Email |
sanjiv3303@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| KLE’S Dr.Prabhakar Kore hospital and Medical Research Centre , Belgaum- 500010 Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
KLE University Institute Of Physiotherapy |
| Address |
KLE University Institute Of Physiotherapy, JNMC campus Nehru Nagar, Belgaum. Karnataka 590010 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Neelam J Patel |
KLEsDr. Prabhakar Kore Hospital and MRC ,Department of Physiotherapy ,OPD No.13 |
Department of Physiotherapy, OPD no 13,Dr. Prabhakar Kore hospital and MRC,Nehrunagar, Belgaum-590010,Karnataka
Belgaum
KARNATAKA |
9916718147
08312472777
neelamp811@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIPT Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
SICK Scapula, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Closed kinematic chain exercises |
Closed kinematic chain exercises for 3 weeks, alternate days( thrice a week ), 45 minutes duration. |
| Comparator Agent |
Open kinematic chain exercises |
Open kinematic chain exercises for 3 weeks, alternate days (thrice a week), 45 minutes duration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Participants positive for SICK scapula type I and II asymptomatic,
Willing to participate in the study,
Involved in competitive level of overhead sports. |
|
| ExclusionCriteria |
| Details |
Participants not meeting the inclusion criteria, Symptomatic ,
Recent shoulder injury duration less than 6 months,
Any other shoulder pathology except SICK scapula, SICK scapula type III,
Musculoskeletal impairments, behaviorally disturbed or other psychiatric problems, visual disturbances,cardiovascular insufficiency .
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Functional Throwing Performance Index(FTPI),
Davies Closed Kinetic Chain Upper Extremity stability Test,
Scapular Distance using Lateral Scapular Slide Test (LSST),
Pectoralis Minor Length, Range of Motion (ROM). |
Functional Throwing Performance Index(FTPI), Davies Closed Kinetic Chain Upper Extremity stability Test,
Scapular Distance using Lateral Scapular Slide Test (LSST),
Pectoralis Minor Length, Range of Motion (ROM), Outcome Measures assess pre 1st day and post treatment end of 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Range of Motion (ROM) |
Range of Motion (ROM) ,Outcome Measure assess pre 1st day and post treatment end of 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/06/2013 |
| Date of Study Completion (India) |
Date Missing |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present study will be intended to compare the effect of open and closed kinematic chain exercises on SICK scapula in competitive overhead athletes for 3 weeks. Hypothesis: Null Hypothesis[H0]: Open kinematic chain exercises and closed kinematic chain exercises will not be effective for SICK scapula in overhead athletes for 3 weeks. Alternate Hypothesis[Ha]: Open kinematic chain exercises and closed kinematic chain exercises will be effective for SICK scapula in overhead athletes for 3 weeks.
|