| CTRI Number |
CTRI/2018/07/014761 [Registered on: 06/07/2018] Trial Registered Prospectively |
| Last Modified On: |
04/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effect Of various taping methods on measurements of functional performance in athletes with recurring ankle inversion twists. |
|
Scientific Title of Study
|
Effect Of Kinesiotaping and Athletic taping on measurements of functional performance in athletes with chronic inversion ankle sprains. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ADITI ANANT PATIL |
| Designation |
PG student |
| Affiliation |
Sancheti institute college of physiotherapy |
| Address |
Sancheti healthcare academy,
Sancheti institute college of physiotherapy ,
11/12 Thube park , Shivajinagar.
Pune
MAHARASHTRA
Pune-411005
India |
| Phone |
020-25539393 |
| Fax |
|
| Email |
aditipatil630@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ANAND GANGWAL |
| Designation |
Professor |
| Affiliation |
Sancheti institute college of physiotherapy |
| Address |
sports section physiotherapy department,basement,Sancheti institute of orthopaedics and rehabilitation, 16,Shivajinagar,Pune 411005.
Pune
MAHARASHTRA
411005
India |
| Phone |
9960323333 |
| Fax |
|
| Email |
anandgangwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANAND GANGWAL |
| Designation |
Professor |
| Affiliation |
Sancheti institute college of physiotherapy |
| Address |
sports section physiotherapy department,basement,Sancheti institute of orthopaedics and rehabilitation, 16,Shivajinagar,Pune 411005.
Pune
MAHARASHTRA
411005
India |
| Phone |
9960323333 |
| Fax |
|
| Email |
anandgangwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti institute college of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Sancheti institute college of Physiotherapy |
| Address |
Sancheti healthcare academy,
Sancheti institute college of physiotherapy ,
11/12 Thube park , Shivajinagar. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| ADITI PATIL |
Sancheti institute for orthopaedics and rehab |
sports section physiotherapy department,basement,
16,Shivajinagar,Pune 411005.
Pune
MAHARASHTRA |
9920188211
aditipatil630@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board, sancheti institute of orthopaedics and rehabilitaion,Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
athletes with chronic inversion ankle sprain having functional ankle instability, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Athletic taping |
Patient in supine position with foot dorsiflexed first anchor will be applied at the level of lower 1/3rd of tibia then next tape to be applied from medial to lateral side of the foot over the malleolis. Next tape starts from the lateral part of lower 1/3rd then over the Achilles tendon continued over the heel over the plantar surface and back to the starting point of this tape on the lateral part. End it with the final anchoring . |
| Intervention |
Kinesiotaping |
4 strips of tape will be used (20%-35%of moderate tension)
1)Patient in prone and foot in relaxed plantar-flexed position.tape will be placed approximately from the origin to insertion of posterior tibialis muscle.
2)Patient in supine for further taping procedure origin to insertion of anterior tibialis muscle
3)Third strip from origin to insertion of peroneus longus muscle
4)Fourth strip will begin just anterior to the lateral malleolus,extended under the plantar aspect of foot and will be pulled up the transverse arch of the foot
|
| Comparator Agent |
no tape |
Functional tests will be carried without taping (baseline) |
| Intervention |
placebo taping |
Micropore tape will be applied over the ankle. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Sustained recurrent ankle sprains.(atleast 3 sprains)
2.Diagnosis of functional ankle instability[using Cumberland ankle instability
tool]
3.Individuals who can read and write in English
|
|
| ExclusionCriteria |
| Details |
1.History of Ankle fracture.
2.Any neurological deficits.
3.Any lower limb injury within 3 months of participation.
4.Current participation in any physiotherapy programme.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Cumberland ankle instability scale to measure severity of functional ankle instability
2)star excursion balance test
3)vertical jump test
4)T-test for agility |
Scale at the start of project.
2,3,4th outcome after every taping technique.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)star excursion balance test
2)vertical jump test
3)T-test for agility |
After every taping technique |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
09/07/2018 |
| 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="1"
Months="2"
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
|
Chronic inversion ankle sprains are common in athletes. It has a considerable impact on their performance and has led to absence at their training sessions and competitions. Taping supports ankles and helps prevent further instability and sprains. The effect of taping is disputed in literature whether it affects the performance or performance remains the same. Thus this study aims at understanding the effect of kinesiotaping and athletic taping on measurements of functional performance in athletes with chronic inversion ankle sprains. Hypothesis : Tapes will have a significant effect on functional performance. Clinical importance : Taping allows athletes to remain active while injured and also prevent further injuries. Thus helps prevent absenteeism at training or competitions.
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