| CTRI Number |
CTRI/2024/12/077732 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Kinesio taping on the calf muscle activity,strength,fatigue and jump performance in university athletes |
|
Scientific Title of Study
|
Inhibitory effect of Kinesio taping on the medial gastrocnemius muscle activity muscle strength muscle fatigue and countermovement jump height on university athletes a randomized controlled trial |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saurabh Sharma |
| Designation |
Associtate Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre For Physiotherapy And Rehabilitation Sciences Jamia Millia
Islamia, Jamia Nagar, Okhla Vihar south Delhi 110025 India Jamia
nagar, Okhla Vihar, New Delhi
South
DELHI
110025
India |
| Phone |
9899214134 |
| Fax |
|
| Email |
ssharma@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Saurabh Sharma |
| Designation |
Associtate Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre For Physiotherapy And Rehabilitation Sciences Jamia Millia
Islamia, Jamia Nagar, Okhla Vihar south Delhi 110025 India Jamia
nagar, Okhla Vihar, New Delhi
South
DELHI
110025
India |
| Phone |
9899214134 |
| Fax |
|
| Email |
ssharma@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Swati Anthwal |
| Designation |
Student |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre For Physiotherapy And Rehabilitation Sciences Jamia Millia
Islamia, Jamia Nagar, Okhla Vihar south Delhi 110025 India Jamia
nagar, Okhla Vihar, New Delhi
South
DELHI
110025
India |
| Phone |
7455938541 |
| Fax |
|
| Email |
swatianthwal2386@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre For Physiotherapy And Rehabilitation Sciences, Jamia Millia Islamia, Jamia Nagar, Okhla Vihar South Delhi 110025 India |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia New Delhi |
| Address |
Centre For Physiotherapy And Rehabilitation Sciences, Jamia Millia Islamia, Jamia Nagar, Okhla Vihar South Delhi 110025 India
|
| Type of Sponsor |
Contract research organization |
|
|
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 Sourabh Sharma |
Jamia Millia Islamia |
Centre For
Physiotherapy and
Rehabilitation Sciences,
Jamia Millia Islamia, Jamia Nagar, Okhla Vihar South Delhi 110025 India
South
DELHI |
09899214134
ssharma@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE JAMIA MILLIA ISLAMIA NEW DELHI-110025 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy university level athletes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Daily training |
Group C will perform its daily routine training.The group
will be analyzed at baseline for surface EMG, hand-held dynamometer, countermovement jump
high, and heel rise test. The dependent variables will subsequently be examined for changes in
each group after three days. |
| Intervention |
Inhibitory kinesio taping® ( 20% stretch |
The kinesio taping® will be applied to the medial gastrocnemius with
the Y-shaped technique. group B will receive inhibitory
kinesio taping® with 20% stretch. groups
will be analyzed at baseline for surface EMG, hand-held dynamometer, countermovement jump
high, and heel rise test. The dependent variables will subsequently be examined for changes in
each group after three days |
| Intervention |
Inhibitory kinesio taping® ( 50% stretch) |
The kinesio taping® will be applied to the medial gastrocnemius with
the Y-shaped technique. Group A will receive inhibitory kinesio taping®
which will be applied to the calf muscle with 50% stretch, groups
will be analyzed at baseline for surface EMG, hand-held dynamometer, countermovement jump
high, and heel rise test. The dependent variables will subsequently be examined for changes in
each group after three days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
1. University athletes in the age group 18 to 26 both males and females
2. Athletes should be involved in sport-specific training at least 2 days per week
3. The calf girth difference is not more than 15% compared to the contralateral leg
4. Single leg Hop test.
• For male collegiate athlete - 192±20cm (min. distance of jump)
• For female collegiate athlete - 149±17cm (min. distance of jump |
|
| ExclusionCriteria |
| Details |
1. Any history of spinal, hip, knee, or foot pathology since the last 6 months
2. Leg length discrepancy
3. Allergic to any type of tape, adhesive, or glue.
4. Any rheumatologic or neurological disorder or myofascial trigger points in the
gastrocnemius muscle.
5. Any lower extremity surgery in the past 1year or musculoskeletal disorders that would
prohibit the athlete from participating in sports
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Surface Electromyography
Countermovement jump |
At time 0 to 3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Anthropometric measurement
Calf muscle fatigue
Muscle strength assessment
|
At time 0 to 3 days |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
15/12/2024 |
| 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="0"
Months="6"
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
|
All the athletes will be informed about the nature, purpose, and possible risks involved in the study, and informed written consent will be taken from them before participation. All athletes will be familiarized with all testing procedures and training before the commencement of the study and then all of them will be submitted to an anthropometric evaluation. Then they will be randomly allocated into one of the three groups using random sequence generator software, as groups A, B, and C. An adhesive waterproof kinesio taping® 5 cm wide and 0.5 mm thick will be used. The athletes’ legs will be shaved from the knee down to increase the adhesion of the taping .The kinesio taping® will be applied to the medial gastrocnemius with the Y-shaped technique .Group A will receive inhibitory kinesio taping® which will be applied to the calf muscle with 50% stretch, while group B will receive inhibitory kinesio taping® with 20% stretch. Group C will perform its daily routine training. All the groups will be analyzed at baseline for surface EMG, hand-held dynamometer, countermovement jump high, and heel rise test. The dependent variables will subsequently be examined for changes in each group after three day |