| CTRI Number |
CTRI/2024/03/064049 [Registered on: 13/03/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
To observe the effect of core exercise on Power Strength Speed and Balance in wheelchair athletes |
|
Scientific Title of Study
|
Effect of core stabilization exercise on Power Strength Speed and Balance in wheelchair athletes- An Experimental study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohan Navalgatti |
| Designation |
PG Student |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
Department of sports physiotherapy, Room no. 8, Advance physiotherapy OPD, KLE hospital, Nehru Nagar, Belagavi.
Belgaum
KARNATAKA
590006
India |
| Phone |
9739419464 |
| Fax |
|
| Email |
navalgattirohan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dhaval Chivate |
| Designation |
Assistant Professor |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
Department of sports physiotherapy, Room no. 8 Advance physiotherapy OPD KLE hospital, Nehru Nagar Belagavi.
Belgaum
KARNATAKA
590006
India |
| Phone |
08494869771 |
| Fax |
|
| Email |
d_chivate@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dhaval Chivate |
| Designation |
Assistant Professor |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
Department of sports physiotherapy Room no. 8, Advance physiotherapy OPD KLE hospital, Nehru Nagar Belagavi.
Belgaum
KARNATAKA
590006
India |
| Phone |
08494869771 |
| Fax |
|
| Email |
d_chivate@yahoo.com |
|
|
Source of Monetary or Material Support
|
| KLE academy of higher education and research |
|
|
Primary Sponsor
|
| Name |
Rohan Navalgatti |
| Address |
Department of sports physiotherapy, Room no. 8, Advance physiotherapy OPD, KLE hospital, Nehru Nagar, Belagavi. |
| Type of Sponsor |
Other [SELF SPONSORED] |
|
|
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 Rohan Navalgatti |
KLEs Dr Prabhakar Kore hospital and medical research centre |
Nehru nagar Belagavi
Belgaum
KARNATAKA |
9739419464
navalgattirohan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical committee KLEU institute of physiotherapy belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
wheelchair bound athlete. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Core stabilization exercises |
week 1
Sunshine arm circle
Tummy twist
Hand squeeze
Ball chest press
Front arm raise
Duck wing squeeze
Sit and reach
Elbow to knee
Around the big wide world
10 reps/set
3 sets/exercise
Week 2
Sunshine arm circle
Tummy twist
Hand squeeze
Ball chest press
Front arm raise
Duck wing squeeze
Sit and reach
Elbow to knee
Around the big wide world
15 reps/set
3 sets/exercises
Week 3
Sunshine arm circle
Tummy twist
Hand squeeze
Ball chest press
Front arm raise
Duck wing squeeze
Sit and reach
Elbow to knee
Around the big wide world
20 reps/set
3 sets/exercises
For all exercises
Frequency - Thrice a week
Rest interval - 48 hours between workouts sessions
Intensity - 80-100 %
Duration - 3 weeks
40- 60 minutes/ session
Pattern - Minimum 3 different exercises/ session
Type - Isolated to Multi-joint exercises
|
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. All gender athletes of age 18-45 years
2. Wheelchair bound athletes
3. Athletes with sporting experience ≥ 1 years and training minimum thrice a week
4. Athletes who are willing to participate
|
|
| ExclusionCriteria |
| Details |
Individual with Systemic illness, Mental or cognitive impairments, Upper limb disability, Shoulder joint pathology, history of upper limb surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The medicine ball throw test
2. Pressure biofeedback
3. Sprint test
4. Trunk balance test |
At Baseline and post 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
Final Enrollment numbers achieved (Total)= "21"
Final Enrollment numbers achieved (India)="21" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/03/2024 |
| Date of Study Completion (India) |
27/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
27/03/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 evaluate the effect of core stabilization exercise on power, strength, speed and balance in wheelchair athletes. Inclusion criteria - 1. Athletes of all genders aged between 18-45 2. Wheelchair bound athletes 3. Athletes with sporting experience ≥ 1 years and training minimum thrice a week 4. Athletes willing to participate
Exclusion criteria - 1. Individual with Systemic illness, Mental or cognitive impairments, Upper limb disability, Shoulder joint pathology, history of upper limb surgery
Outcome measures - 1. Medicine ball throw test for upper extremity power 2. Pressure biofeedback for back and abdominal muscles strength 3. Sprint test for athlete’s speed 4. Modified functional reach test, bilateral reach test, and lateral reach for trunk balance
procedure- This is a single group study where participants will be given core stabilization exercises for 3 weeks.
|