| CTRI Number |
CTRI/2024/02/062181 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Revitalize Your Core Unlocking Athlete Potential with Dynamic Core Slider Workouts and Kinesiology Taping for Abdominal Muscle Strain Relief. |
|
Scientific Title of Study
|
Effect of core slider exercise and kinesiology taping on pain, tenderness and functional performance in athletes with abdominal muscles strain. |
| 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 Minhaz Ahmad Khan |
| Designation |
PG SCHOLAR |
| Affiliation |
Amity Institute of Health Allied Science |
| Address |
Room No. 07 Lower Ground Floor F1 Block Amity Institute of Health Allied Sciences Department of Physiotherapy, Amity University Noida Sector 125 Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9507207760 |
| Fax |
|
| Email |
minhaz.baghra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Jasobanta Sethi |
| Designation |
Director |
| Affiliation |
Amity Institute of Health Allied Science |
| Address |
Amity University Uttar Pradesh, F-1, LGF-07, Sector-125, Noida-201301, India
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9821662045 |
| Fax |
|
| Email |
Jsethi@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Jasobanta Sethi |
| Designation |
Director |
| Affiliation |
Amity Institute of Health Allied Science |
| Address |
Amity University Uttar Pradesh, F-1, LGF-07, Sector-125, Noida-201301, India
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9821662045 |
| Fax |
|
| Email |
Jsethi@amity.edu |
|
|
Source of Monetary or Material Support
|
| Physio Guru Physiotherapy and Rehabilitation Center, Room No. 01 Ground Floor Department of Physiotherapy D 32 Sector 108 Noida |
|
|
Primary Sponsor
|
| Name |
Minhaz Ahmad Khan |
| Address |
Amity Institute of Health Allied Sciences Amity University Noida F-1, sector -125,Noida-201301, India |
| 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 Minhaz Ahmad Khan |
Physio Guru Physiotherapy and rehabilitation Center |
Room No. 01 Ground Floor Department of Physiotherapy D 32 Sector 108 Noida
Gautam Buddha Nagar
UTTAR PRADESH |
950720760
minhaz.baghra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee Amity Institute of Health Allied sciences Amity University UTTAR PRADESH |
Approved |
| Physio Guru Physiotherapy and Rehabilitation Center |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S390||Injury of muscle, fascia and tendon of abdomen, lower back and pelvis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional therapy |
To improve the pain, tenderness and
functional performance in athletes with RICE , sit up exercise , The trunk curl , The trunk curl with twist |
| Intervention |
Effect of core slider exercise and kinesiology taping |
Improvement on pain, tenderness and
functional performance in athletes with abdominal muscles strain .
Administer the interventions for a predetermined period 4 Weeks . Ensure regular monitoring and adherence to the intervention protocols.
Week 1-4 Program Exercise Program for 3 days in a week. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Sports person
2. Abdominal muscle strain
3. Pain and tenderness
3. Gender- Both male and female
4. Age- 18-30 years
5. Willingness to participate |
|
| ExclusionCriteria |
| Details |
1. Traumatic injuries
2. Any neurological condition
3. Any infections around chest and trunk
4. Rib fracture
5. Age- below 18 years and above 30 years old
6. Non-athletes
7. Chronic medical conditions
8. Pregnancy
9. Allergies to material used for kinesiology taping
10. Previous participation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain and tenderness |
The measurement will be done at baseline which is starting point of study and after 4 weeks at the end NPRS for pain and algometer for tenderness at baseline and after 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional performance |
Baseline and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
06/02/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
13/06/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
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
|
The study will give you insight on the outcome of effect of core slider exercise and kinesiology taping on pain, tenderness and functional performance in athletes with abdominal muscles strain to the clinical fraternity as a new information for prevention and treatment. This study also may provide insights into methods that can help athletes recover from strains and return to their sports faster. This study contributes to the scientific understanding of muscle strain treatment in athletes, potentially leading to advancements in sports medicine. There is no study done with core slider and kinesiology taping on abdominal oblique muscles str |