| CTRI Number |
CTRI/2017/04/008399 [Registered on: 24/04/2017] Trial Registered Prospectively |
| Last Modified On: |
10/01/2020 |
| 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
|
Taping and foot exercises in runners |
|
Scientific Title of Study
|
Effect of taping with intrinsic foot muscle strengthening exercises on dynamic balance in elite runners with pronated foot: A randomized clinical placebo trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka P More |
| Designation |
Post graduation student |
| Affiliation |
Manipal University |
| Address |
Department of Physiotherapy,N0.98,Rustam Bagh, Old Airport Road, Manipal Hospital, Bangalore
Bangalore
KARNATAKA
560017
India |
| Phone |
8806345069 |
| Fax |
|
| Email |
p93more@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Karvannan H |
| Designation |
Assistant Professor- Selection Grade |
| Affiliation |
Manipal University |
| Address |
Department of Physiotherapy,N0.98,Rustam Bagh, Old Airport Road, Manipal Hospital, Bangalore
Bangalore
KARNATAKA
560017
India |
| Phone |
9986565966 |
| Fax |
|
| Email |
karvannan.h@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Prem V |
| Designation |
Associate Professor |
| Affiliation |
Manipal University |
| Address |
Department of Physiotherapy,N0.98,Rustam Bagh, Old Airport Road, Manipal Hospital, Bangalore
Bangalore
KARNATAKA
560017
India |
| Phone |
9886647732 |
| Fax |
|
| Email |
prem.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy,School of allied health sciences, Manipal university, Manipal 576104 |
|
|
Primary Sponsor
|
| Name |
SOAHS Manipal University |
| Address |
Department of Physiotherapy,N0.98,Rustam Bagh, Old Airport Road, Manipal Hospital, Bangalore |
| 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 |
| Priyanka P More |
Manipal Hospital Bangalore |
Orthopaedic Outpatient Physiotherapy Department,Upper basement Manipal Hospital,Old airport road, Bangalore
Bangalore
KARNATAKA |
8806345069
p93more@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Committee SOAHS Manipal University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
pronated foot , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anti-pronation rigid taping with intrinsic muscle strengthening |
Anti-pronation taping with intrinsic muscle exercises will be given for 6 weeks. 2 sessions of supervised intervention per week.Anti-pronation rigid taping will be applied twice in week. Intrinsic muscle exercises includng Veles forward lean, reverse tandem gait will be given for 6 weeks.Short foot exercises will be given as follows- Week 1- short foot exercises in sitting position will be given.Week 2- progression of short foot exercises in double standing position.Week 3 and 4- short foot exercises in single standing position.
Week 5 and 6 - short foot exercises in half squat position.
|
| Comparator Agent |
Placebo taping for pronated foot with intrinsic muscle strengthening exercises |
Placebo anti-pronation taping with intrinsic muscle exercises will be given for 6 weeks. 2 sessions of supervised intervention per week.Placebo anti-pronation taping without tension will be applied twice in week. Intrinsic muscle exercises includng Veles forward lean, reverse tandem gait will be given for 6 weeks.Short foot exercises will be given as follows- Week 1- short foot exercises in sitting position will be given.Week 2- progression of short foot exercises in double standing position.Week 3 and 4- short foot exercises in single standing position.
Week 5 and 6 - short foot exercises in half squat position.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Elite runners with pronated foot (navicular drop >10mm)
Elite runners who score +6 and above score according to Foot Posture Index-6
|
|
| ExclusionCriteria |
| Details |
Elite runners with previous history of lower limb injury since last six months |
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Star excursion balance test |
2 points
1st point before intervention
2nd point after 6 weeks of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Foot posture index 6,Navicular drop test,Hop test |
2 |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
27/04/2017 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Running is dynamic sport in which foot plays an important role for projecting the body forward and increasing velocity. Three foot types are seen- neutral,supinated,pronated. Pronated foot leads to increase in medial forces in lower limb which is the cause for many injuries. In runners with pronated foot , time to achieve maximum pronation is delayed by 40% which delays the onset of supination in turn delaying the propulsion of foot and affects the velocity. Therefore, foot cannot act as an effective lever.Studies have shown that people with pronated foot have affected balance as it influences somatosensory input via changes in joint mobility or surface contact area or changes in muscular strategies. Many interventions have been used to correct this pronated foot like foot orthoses, motion control footwear, etc. There is paucity of literature on effect of anti-pronation rigid taping and intrinsic muscle strengthening on dynamic balance. |