| CTRI Number |
CTRI/2023/10/058357 [Registered on: 05/10/2023] Trial Registered Prospectively |
| Last Modified On: |
23/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Immediate Effects of Kinesio- Taping on Foot Posture, Plantar Pressures and Balance in Stroke Patients. |
|
Scientific Title of Study
|
Immediate Effects of Kinesio- Taping on Foot Posture, Plantar Pressure and Balance in Stroke Patients: A Randomised Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jhanvi Patwa |
| Designation |
Post Graduate Student |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, 11/12, Thube Park, Shivajinagar, Pune 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9833627724 |
| Fax |
|
| Email |
jhanvipatwa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radha Bhattad |
| Designation |
HOD Neurophysiotherapy |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, 11/12, Thube Park, Shivajinagar, Pune 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9860542511 |
| Fax |
|
| Email |
drradhabhattad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radha Bhattad |
| Designation |
HOD Neurophysiotherapy |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, 11/12, Thube Park, Shivajinagar, Pune 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9860542511 |
| Fax |
|
| Email |
drradhabhattad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation 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 |
| Dr Jhanvi Patwa |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy, 11/12, Thube Park, Shivajinagar, Pune 411005
Pune
MAHARASHTRA |
9833627724
jhanvipatwa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti Institute for Orthopaedics and Rehabilitation Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stroke Population |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kinesio- Taping |
• Application of Kinesio Tape to correct plantarflexion and eversion component of the ankle will be done for the experimental group by therapist 2. Before KT application, the skin will be cleaned and dried to remove all moisture and oil and then shaved if necessary. Standard 2-inch Kinesio Tape will be used. The patients will be in supine position during taping, with their hip, knee, and ankle joints in neutral position. The kinesio I strip will be applied with maximum tension (100%). Each strip simultaneously applied force in the directions of dorsiflexion and eversion. Three I strips, each covering approximately half the previous strip, will be attached from 2-3 cm superior to the medial malleolus and passed around the ankle joint from the plantar surface of foot, then fixed at the top of the lateral malleolus. The strips will be applied across the ankle joint from proximal to distal. |
| Comparator Agent |
Placebo Taping |
Control group will receive placebo taping, i.e tape will be applied without any stretch by therapist 2. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients between the age of 40-60 years.
2)Patients with hemiplegia due to ischemic or haemorrhagic stroke > 3 months post stroke
3)Patients with equinovarus foot posture in non-weight bearing position.
4)Patients with Brunnstrom Stage IV who can walk independently.
5)Patients who are able to follow commands.
|
|
| ExclusionCriteria |
| Details |
1)Patients with any history of lower limb surgery, trauma, fracture or joint dislocation in the lower limbs in the last 6 months.
2)Patients with known skin allergic reaction to Kinesio Tape.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)FPI-6 for static foot postures
2) Portable force plate (Podiatech) for plantar pressures
3)Functional Reach Test (FRT) and Star Excursion Balance Test (SEBT) for balance.
|
Pre intervention and immediately post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
09/10/2023 |
| Date of Study Completion (India) |
31/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/05/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
About 80% of chronic stroke survivors have varying degrees of abnormal gait and impaired locomotion capability. Spasticity in the ankle and foot muscles is very common, and often results in various abnormal ankle and foot postures, including equinus, varus, equinovarus, and striatal toe foot postures. Ankle equinovarus foot postures are seen in up to 20-56%. Kinesio Taping (KT) concentrating on correction of its both components (Plantarflexion and inversion) is important in restoring normal joint function. Despite the current use of KT as a part of clinical practice in physical therapy, its clinical effects on postural stability and plantar pressures have not been extensively studied in stroke patients. Hypothesis: There are immediate effects of Kinesio Taping on foot posture, plantar pressures and balance in stroke patients. |