| CTRI Number |
CTRI/2025/12/099163 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| 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
|
Effect of taping and electrical stimulation intervention on participants with chronic stroke with outcome to analyse movement and gait |
|
Scientific Title of Study
|
Effect of taping vs anterior rafting strap binding technique combined with FES in improving motor and gait outcomes in chronic MCA stroke survivors. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kshama Susheel Shetty |
| Designation |
Physiotherapist |
| Affiliation |
Alvas College of Physiotherapy and Research Centre |
| Address |
Alvas College of Physiotherapy and Research Centre.
Department of Neurological Sciences
Alvas Health Center
Moodabidri- 574227
Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9591593863 |
| Fax |
|
| Email |
poonjakshama@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kshama Susheel Shetty |
| Designation |
Physiotherapist |
| Affiliation |
Alvas College of Physiotherapy and Research Centre |
| Address |
Alvas College of Physiotherapy and Research Centre
Department of Neurological Sciences
Alvas Health Center
Moodabidri-574227
Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9591593863 |
| Fax |
|
| Email |
poonjakshama@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kshama Susheel Shetty |
| Designation |
Physiotherapist |
| Affiliation |
Alvas College of Physiotherapy and Research Centre |
| Address |
Alvas College of Physiotherapy and Research Centre
Department of Neurological Sciences
Alvas Health Center
Moodabidri-574227
Karnataka
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9591593863 |
| Fax |
|
| Email |
poonjakshama@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas College of Physiotherapy and Research Centre
Department of Neurological Sciences
Alvas Health Center
Moodabidri-574227
Karnataka |
|
|
Primary Sponsor
|
| Name |
Alvas College of Physiotherapy and Research Centre |
| Address |
Alvas Health Center
Moodabidri-574227
Karnataka |
| Type of Sponsor |
Other [Institution ] |
|
|
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 Kshama Susheel Shetty |
Alvas College of Physiotherapy |
Alvas College of Physiotherapy and Research Centre
Department of Neurological Sciences
Out Patient Department
Alvas Health Centre
Moodubidri-574227
Dakshina Kannada
KARNATAKA |
9591593863
poonjakshama@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Alvas College of Physiotherapy and Research Centre - Institutional Ethical Committee |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I633||Cerebral infarction due to thrombosis of cerebral arteries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1 )Anterior Rafting Strap Binding
and 2)Kinesio Taping |
Anterior Rafting Strap Binding placed from the
forefoot of the affected leg, crossing it in
front of the ankle and then wrapping
around the back of the tibial shank and
knee joint, and securing around the waist
with the help of a waist belt.
and
Kinesio Taping applied to dorsiflexors. |
| Intervention |
FUNCTIONAL ELECTRICAL STIMULATION |
FUNCTIONAL ELECTRICAL STIMULATION 20 MINUTES FOR 5 DAYS PER WEEK FOR 8 WEEK |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Both genders aged from 45 to 65 years,
diagnosed with middle cerebral artery
infarction stroke by the qualified
neurologist, more than 6 months from the
onset of stroke, with Brunnstrom score for
lower extremity above 3 and ability to walk
at least 10 metres unassisted or with
assistive devices, |
|
| ExclusionCriteria |
| Details |
Individuals with unstable medical
conditions, aphasia, cognitive dysfunctions,
vision or hearing deficits, history of
musculoskeletal or other systemic
comorbidities, and unwilling to provide
consent. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Baseline and 8 weeks post-intervention
outcomes measured were Plantar flexor
spasticity, dorsiflexion range, and gait
speed |
Baseline and 8 weeks post-intervention
outcomes measured were Plantar flexor
spasticity, dorsiflexion range, and gait
speed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
31/01/2026 |
| 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="3"
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
|
TWO GROUPS WITH 22 PATIENTS ALLOCATED BY SIMPLE RANDOMISED METHOD WITH DURATION OF 8 WEEKS. FIRST GROUP RECIEVES FUNCTIONAL ELECTRICAL STIMULATION AND KINESIOTAPING WHILE OTHER GROUP RECIEVES ANTERIOR RAFTING STRAP BINDING , WITH PATIENTS WITH CHRONIC MCA stroke between age group of 45 to 65 years. FUNCTIONAL ELECTRICAL STIMULATION GIVEN FOR DURATION OF 20 MINUTES 5 TIMES A WEEK . BASELINE AND 8 WEEKS POST INTERVENTION OUTCOME MEASURED WERE PLANTAR FLEXOR SPASTICITY , DORSIFLEXION RANGE AND GAIT SPEED. THIS STUDY HELPS TO SHOWCASE POTENTIAL EFFECT OF FUNCTIONAL ELECTRICAL STIMULATION WITH KINESIOTAPPING AND ANTERIOR RAFTING STRAP BINDING PROVIDES VALUABLE INFORMATION FOR REHABILITATION PROFESSIONALS INVOLVED INSTROKE REHABILITATION.
|