| CTRI Number |
CTRI/2025/12/099804 [Registered on: 24/12/2025] Trial Registered Prospectively |
| Last Modified On: |
23/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To study the immediate effects of elastic therapeutic tape in helping patients with paralysis of upper arm in improving shoulder muscle activity and arm movement. |
|
Scientific Title of Study
|
Immediate Effects of Kinesio Taping on Deltoid Muscle Activity and Active Range of Motion in Chronic Stroke Patients: A Randomized Controlled Crossover 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 |
Dr Sheetal Masaye |
| Designation |
Postgraduate student |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy,Third floor, Department of Neurophysiotherapy ,Tilak Maharashtra Vidyapeeth,
Block J,sector 14,near Raghunath Vihar,Kharghar, Navi Mumbai,India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8600130228 |
| Fax |
|
| Email |
masayesheetal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranjal Grover |
| Designation |
Principal |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy,Third floor, Department of Neurophysiotherapy ,Tilak Maharashtra Vidyapeeth,
Block J,sector 14,near Raghunath Vihar,Kharghar, Navi Mumbai,India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9619064917 |
| Fax |
|
| Email |
drpranjal.grover@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranjal Grover |
| Designation |
Principal |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy,Third floor, Department of Neurophysiotherapy ,Tilak Maharashtra Vidyapeeth,
Block J,sector 14,near Raghunath Vihar,Kharghar, Navi Mumbai,India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9619064917 |
| Fax |
|
| Email |
drpranjal.grover@gmail.com |
|
|
Source of Monetary or Material Support
|
| TMVs Lokmanya Tilak College of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy,Third floor, Department of Neurophysiotherapy ,Tilak Maharashtra Vidyapeeth,
Block J,sector 14,near Raghunath Vihar,Kharghar, Navi Mumbai, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| TMVs Lokmanya Tilak College of Physiotherapy |
TMVs Lokmanya Tilak College of Physiotherapy,Third floor, Department of Neurophysiotherapy ,Tilak Maharashtra Vidyapeeth,
Block J,sector 14,near Raghunath Vihar,Kharghar, Navi Mumbai, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sheetal Masaye |
TMVs Lokmanya Tilak College of Physiotherapy |
TMVs Lokmanya Tilak College of Physiotherapy,Third floor, Department of Neurophysiotherapy ,Tilak Maharashtra Vidyapeeth,
Block J,sector 14,near Raghunath Vihar,Kharghar, Navi Mumbai,India
Raigarh
MAHARASHTRA |
8600130228
masayesheetal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMVs Lokmanya Tilak College of Physiotherapy Institutional Ethics Committee Academic |
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 |
The participants will undergo a washout period of 1 week before undergoing for Kinesio Taping.
Prior to application of Kinesio taping , Surface EMG of middle fibres of Deltoid muscle during shoulder abduction and Shoulder abduction active range of motion of hemiplegic upper extremity will be assessed and recorded .
Application of Kinesio Taping :Taping of deltoid muscle will be done by ‘Y’ strip Taping technique with anterior and posterior strips . The application will extend from the acromioclavicular joint down to a point just below where the deltoid muscle inserts, to promote muscle contraction. The elastic tape will be applied with a tension ranging from 10% to 15% of its total elastic strength with paper-off. After application of Kinesio Taping, surface EMG of middle fibres of Deltoid muscle during shoulder abduction and Shoulder abduction Active Range of Motion will be recorded.
|
| Comparator Agent |
Sham Taping |
All the participants will first undergo a sham kinesio taping intervention. Surface EMG activity for Deltoid muscle and active range of shoulder abduction will be recorded before and after sham taping.
For sham taping , the tapes will be applied for middle fibres of Deltoid muscle without tension (Placebo taping).
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult Chronic stroke patients ( post-stroke time exceeding 6 months) due to unilateral stroke of any hemisphere .
2.Shoulder active range of motion more than 10 degrees but less than 90 degrees in abduction in sitting position
3.Spasticity level for shoulder abductor muscle level of less than 3 on Modified Ashworth Scale (MAS).
4.Normal light touch and pin-prick sensation on the affected shoulder;
5.Mini Mental State Examination (MMSE) score more than or equal to 24
|
|
| ExclusionCriteria |
| Details |
1.People who have had fractures in the spine or upper limbs;
2.Patients with thalamic stroke
3.Individuals who experienced severe shoulder pain;
4.Individuals with shoulder subluxation of more than 3 grade using finger breadth Palpation method
5.Individuals who had allergic reactions on skin due to application of tape.
6.Individuals having previous experience or knowledge about Kinesio Taping
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Surface EMG for Deltoid muscle |
Time point is at baseline & immediately after sham taping that is at 15 mins followed by 8 days of washout period & kinesiotaping having time point at baseline and at 15 mins that is immediately post kinesiotaping |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shoulder Abduction Active Range of Motion using Goniometer |
Time point is at baseline & 15 mins for sham taping followed by a washout period of 8 days & time point for Kinesiotaping is at baseline & 15 mins. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/01/2026 |
| 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="1"
Months="6"
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
|
This study is a randomized, single blinded, crossover trial to study the immediate effects of Kinesio Taping in activation of Deltoid muscle and its effect on shoulder abduction active range of motion in 30 adult chronic stroke patients. Stroke commonly causes long-term motor impairment in upper limb, especially weakness and poor motor control of shoulder muscles like Deltoid. Kinesio Taping is widely used as an adjunct in stroke rehabilitation for enhancing proprioception and joint stability. Some studies suggests that application of KInesio Tape to skin can cause cutaneous stimulation enhancing the neuromuscular activation and physical performance. Although there is a derth of studies which shows the effects of Kinesio Taping on activation of muscle. Therefore, using surface EMG as the primary outcome and shoulder abduction active range of motion as the secondary measure to study the immediate effects of KInesio Taping on muscle activation could help determine its role in improving upper limb function and enhancing rehabilitation outcomes. |