| CTRI Number |
CTRI/2019/02/017373 [Registered on: 01/02/2019] Trial Registered Prospectively |
| Last Modified On: |
25/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Exercises to improve faulty head & shoulder posture, strength and breathing capacities in sports person playing overhead games. |
|
Scientific Title of Study
|
Effectiveness of strength training and stretching on forward head rounded shoulder posture, muscle strength and forced vital capacity in over head athletes-A Randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Payal Dhawale |
| Designation |
PG Student |
| Affiliation |
MGM School of Physiotherapy |
| Address |
MGM School of Physiotherapy
CIDCO, N-6, 431001
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7276155645 |
| Fax |
|
| Email |
payaldhawale62@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Santosh Dobhal |
| Designation |
Assisstant professor |
| Affiliation |
MGM institute of health sciences,navi mumbai |
| Address |
CIDCO, N-6, 431001
CIDCO, N-6, 431001
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9923401079 |
| Fax |
|
| Email |
ptsantosh07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Payal Dhawale |
| Designation |
Post Graduate Students |
| Affiliation |
MGM School of Physiotherapy |
| Address |
N-11, Plot NO-1, HUDCO , Aurangabad.431001
CIDCO, N-6, 431001
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7276155645 |
| Fax |
|
| Email |
payaldhawale62@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGMs School of Physiotherapy, N-6, CIDCO, Aurangabad |
|
|
Primary Sponsor
|
| Name |
Payal Dhawale |
| Address |
N-11, PLOT NO 1 HUDCO Aurangabad |
| Type of Sponsor |
Other [] |
|
|
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 Payal Dhawale |
MGMs Sports Club. |
MGM MEDICAL COLLEGE, n-6 CIDCO, Aurangabad
Aurangabad
MAHARASHTRA |
7276155645
payaldhawale62@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ECRHS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
over head athletes with FHRS posture |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONTROL GROUP- neck isometrics
|
conventional neck isometrics exercises |
| Intervention |
EXPERIMENTAL GROUP- strengthening and stretching |
4 strengthening exercise 3 stretching exercise
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
23.00 Year(s) |
| Gender |
Both |
| Details |
1) Both male& female.
2) Athletes with FHRSP
3) Age 18 to 23
4) Patients who are willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1) CV and SH angle was equal or higher than 50 degree and 52 degree respectively
2) Visual deficits
3) Musculoskeletal pathology
4) Cardiopulmonary pathology
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. forward head angle –rounded shoulder angle
2. strength
3. forced vital capacity |
forward head angle –rounded shoulder angle
2. strength
3. forced vital capacity |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
forward head angle –rounded shoulder angle
2. strength
3. forced vital capacity |
0 |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
02/02/2019 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study design-
Randomized Controlled Trial
Purpose of the study
-was to evaluate the effectiveness of 6 weeks of exercise intervention on FHRS
posture, muscle strength and forced vital capacity in overhead athletes
Objectives-To
evaluate the effect of strength training and stretching on over head athlete
having forward head rounded shoulder on posture, strength of muscles and a
forced vital capacity.
Method –
54 overhead athlete with forward head rounded shoulder posture who meet the
inclusion criteria were included in the study and randomly divided in to two
groups the exercise intervention is given for the 6 weeks to see the
effectiveness, experimental group (n=27) received strengthening and stretching
training and control group received conventional neck isometric exercise (n=27)
pre and post assessment were done for
posture angle CV and RS angle muscle strength of SA,LT,DNF and ER and forced
vital capacity.
Result –
There was significant difference in FHRS posture, muscle strength and FVC in
over head athletes with strength training and stretching. The baseline values
of outcome measures were suggest that the experimental groups showed
statistically significant improvement in terms of FHRS posture, muscle strength
and FVC than control group values.
Conclusion-
study concluded that the exercise intervention given for experimental group was
effective in treating FHRS posture as it improves CV and RS angle, strength of
the muscles and a forced vital capacity in overhead athletes.
|