| CTRI Number |
CTRI/2019/07/020171 [Registered on: 12/07/2019] Trial Registered Prospectively |
| Last Modified On: |
11/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Trial to compare two taping techniques to improve balance and walking in one side paralytic patients. |
|
Scientific Title of Study
|
Comparison between the effect of Kinesio Taping and Rigid Taping of ankle on functional balance and gait parameters in chronic hemiplegic stroke patients. – An Experimental Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hayy Patni |
| Designation |
P.G. Student |
| Affiliation |
Sancheti Institute college of physiotherapy |
| Address |
11/12, Sancheti Institute College Of Physiotherapy, 1st Floor, Department of Neurosciences Physiotherapy, Thube park, Shivajinagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
8097211598 |
| Fax |
|
| Email |
hayy.patni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vivek Kulkarni |
| Designation |
Director and Professor |
| Affiliation |
Sancheti Institute college of physiotherapy |
| Address |
11/12, Sancheti Institute College Of Physiotherapy, 1st Floor, Department of Neurosciences Physiotherapy, Thube park, Shivajinagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
9890611747 |
| Fax |
|
| Email |
vnkulkarni19@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Vivek Kulkarni |
| Designation |
Director and Professor |
| Affiliation |
Sancheti Institute college of physiotherapy |
| Address |
11/12, Sancheti Institute College Of Physiotherapy, 1st Floor, Department of Neurosciences Physiotherapy, Thube park, Shivajinagar, Pune.
Pune
MAHARASHTRA
411005
India |
| Phone |
9890611747 |
| Fax |
|
| Email |
vnkulkarni19@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| 11/12, Sancheti Institute College Of Physiotherapy, 1st Floor, Department of Neurosciences, Thube Park, Shivajinagar, Pune. |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute college of physiotherapy |
| Address |
Sancheti Institute college of physiotherapy, 11/12, THUBE PARK, SHIVAJINAGAR, PUNE. 411005 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Hayy Patni |
Sancheti Hospital |
Lower basement, Department of physiotherapy,Sancheti Hospital, Shivajinagar, Pune.
Pune
MAHARASHTRA |
8097211598
hayy.patni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTUTUTIONAL REVIEW BOARD _ Sancheti Institute of Orthopedics and Research / Agenda 054 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kinesio taping of ankle |
Kinesio taping of ankle that incorporates taping for assisting dorsiflexion and eversion at the ankle. |
| Comparator Agent |
Rigid taping of ankle |
Rigid taping of ankle that incorporates talar stabilizing taping for assisting dorsiflexion at the ankle |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with hemiplegia due to hemorrhagic or ischemic stroke at > 6 months post-stroke
2. Patients able to perform independent gait over 10 m without assistive devices
3. Patients having spasticity in the affected side ankle (Modified Ashworth scale ≤ 1) |
|
| ExclusionCriteria |
| Details |
1. Patients having medical problems other than neurological lesions affecting gait
2. Patients with bilaterally affected limbs
3. Patients with known skin allergic reactions to taping
4. Patients having premorbid or current orthopedic problem involving the lower extremities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. 10-m walk test in meters
2. Ink foot print method for stride length in meters
3. Cadence in number of steps per minute
4. Functional Reach test in centimeters
5. Time up and go test in seconds |
1. Pre Intervention
2. Post Intervention
3. After 24 HRS Post Intervention
For all outcome measures |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/08/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Many patients remain unable to walk or have difficulties with walking after stroke. More over loss of balance also contributes to impaired functional capacity of the patient. It has been reported that only a small proportion can walk with sufficient ability to function effectively within the community. The ability to walk correctly and maintain postural balance is a prerequisite for many daily activities. The rationale behind this study is that, despite the current use of Kinesio Taping as a part of clinical practice in physical therapy, its clinical effects on Functional balance and Gait ability have not been extensively studied. Kinesio taping has many advantages over rigid taping with regards to its application as it is less time consuming. Other advantages of the KT include low cost and easy application along with its prolonged effect relative to rigid taping. Moreover the time constraint of a particular session with the patient gives rise to the need of proper intervention which will be effective in improving functional balance and gait performance. Thus, this study aims to find out which treatment technique will be more beneficial to the patients aiming to achieve proper ambulation and functional balance, saving their time as well as giving a treatment best suited for their needs.
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