| CTRI Number |
CTRI/2024/11/076305 [Registered on: 05/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| 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
|
A study to see the effect of kinesio - taping on Tibialis anterior muscle activation,Spasticity and functional mobility in chronic stroke patients with foot drop. |
|
Scientific Title of Study
|
Long term effect of kinesio - taping on lower-limb recovery in chronic stroke patients with foot drop-A randomized 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 |
DrJagruti Patel |
| Designation |
Assistant Professor |
| Affiliation |
S.S Agrawal Institute of Physiotherapy and Medical Care Education Navsari |
| Address |
S.S Agrawal Institute of Physiotherapy and Medical Care Education, Devina Park society Bardoli Road Navsari
Navsari
GUJARAT
396445
India |
| Phone |
9974661767 |
| Fax |
|
| Email |
jagukpatel57@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhwanit Shah |
| Designation |
Senior Lecturer |
| Affiliation |
Gov Physiotherapy College Surat |
| Address |
Gov Physiotherapy College Surat
Surat
GUJARAT
395001
India |
| Phone |
9033220634 |
| Fax |
|
| Email |
drdhwanit2608@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrJagruti Patel |
| Designation |
Assistant Professor |
| Affiliation |
S.S Agrawal Institute of Physiotherapy and Medical Care Education Navsari |
| Address |
S.S Agrawal Institute of Physiotherapy and Medical Care Education, Devina Park society Bardoli Road Navsari
Navsari
GUJARAT
396445
India |
| Phone |
9974661767 |
| Fax |
|
| Email |
jagukpatel57@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.S Agrawal institute of physiotherapy Navsari |
|
|
Primary Sponsor
|
| Name |
Jagruti Patel |
| Address |
Plot no-12 Manibaug-1 Near saffi hospital Abrama valsad |
| Type of Sponsor |
Other [Self] |
|
|
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 Dhwanit Shah |
S.S Agrawal Institute of Physiotherapy and Medical care Education Navsari |
Department of Physiotherapy Ground Floor, Agrawal college campus,viranjali marge Navsari
Navsari
GUJARAT |
9033220634
drdhwanit2608@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
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 |
Conventional Therapy |
Stretching exercise for tight muscles both upper and lower extremity (30-second hold for 3 times). Active assisted training for subjects who will be not able to perform full range exercises actively (10 times for each). Active movements for subjects who will be able to perform tasks as mentioned above (10 times for each). Trunk exercise (5 times) Balance training - both static and dynamic balance (10 times for each). Gait training. |
| Intervention |
Facilitatory PNF Kinesiological taping of TA and HMs and Conventional therapy |
Facilitatory Taping is applied at the begging of each session. Sessions will be conducted 5 times per week for 4 weeks (total 20 sessions) from the time of study initiation.
A5-cm wide kinesio tex tape will be used, and taping will be applied from the lateral condyle of tibia to the base of first metatarsal bone with the participant in the supine position, after maximal plantar flexion of the ankle joint. For the HMs taping , the table height was adjusted to the level of the participant’s anterior superior iliac spine while standing, and the participant flexed the trunk to induce anterior tilting of the pelvic bone .After this the tape will be applied from ischial tuberosity of the pelvis to the medial condyle of tibia and fibular head. During application 5 cm from the initial site no stretch will be applied after that 30% stretch will be applied for the remaining parts.
Conventional Therapy-Stretching exercise for tight muscles both upper and lower extremity (30-second hold for 3 times). Active assisted training for subjects who will be not able to perform full range exercises actively (10 times for each). Active movements for subjects who will be able to perform tasks as mentioned above (10 times for each). Trunk exercise (5 times) Balance training - both static and dynamic balance (10 times for each). Gait training. |
| Intervention |
Inhibitory Kinesiological taping of calf muscle and conventional therapy
|
Inhibitory Taping is applied in Y shape, the base of Y shaped tape will be strapped on calcaneous where no stretch will be given for first 5 cm and the both legs of Y shaped tape will be strapped on gastrocnemius muscle medial and lateral with 15% stretch.
Conventional Therapy-Stretching exercise for tight muscles both upper and lower extremity (30-second hold for 3 times). Active assisted training for subjects who will be not able to perform full range exercises actively (10 times for each). Active movements for subjects who will be able to perform tasks as mentioned above (10 times for each). Trunk exercise (5 times) Balance training - both static and dynamic balance (10 times for each). Gait training. |
| Intervention |
Not applicable |
Not applicable |
|
Inclusion Criteria
Modification(s)
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Stroke diagnosed with CT/MRI or ascertained by medical reports by qualified medical professionals
2) 6 months post stroke
3) Age of 35-65 individuals who diagnosed with
4) hemorrhagic or ischemic stroke
5) Individuals with drop foot due to stroke were recruited for participation.
6)Brunnstrom stages of recovery stage: 2 to 4
7) Spasticity of ankle plantar flexor muscle Less then or equal to 2 ( According to Modified Ashworth Scale )
8) Able to walk independently over 10 m without assistive devices.
9) Mini mental scale examination grater or equal to 24.
|
|
| ExclusionCriteria |
| Details |
1) Neurological deficits other than stroke
2) Recurrent stroke
3) Contracture/ deformity of ankle joint
4) Perceptual, visual, or vestibular deficits
5) Recent surgery to the affected lower limb
6) Patients with an open wound that hinders the
7) application of kinesio- tape and patients with skin symptoms after applying the tape.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| ROOT MEAN SQUARE(RMS), MAS (Modified Ashworth Scale) |
At baseline and at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional Mobility-TUG, lowerlimb recovery-FMA |
at Baseline & 4 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="147"
Sample Size from India="147"
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 2 |
|
Date of First Enrollment (India)
|
08/11/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
aims and objective To determine the long term effect of facilitatory kinesio taping of lower-leg plus conventional physiotherapy on spasticity of calf muscle, surface electromyography analysis of tibialis anterior muscle, dynamic balance and lower limb recovery in chronic stroke patients with foot drop.
To determine the long term effect of inhibitory kinesio taping of lower-leg plus conventional physiotherapy on spasticity of calf muscle, surface electromyography analysis of tibialis anterior muscle, dynamic balance and lower limb recovery in chronic stroke patients with foot drop.
To compare the long term effect of facilitatory kinesio taping of lower-leg plus conventional therapy, inhibitory kinesio taping of lower-leg plus conventional therapy and conventional therapy alone on spasticity of calf muscle, surface electromyography analysis of tibialis anterior muscle, dynamic balance and lower limb recovery in chronic stroke patients with foot drop.
To determine the long term effect of conventional therapy on spasticity of calf muscle, surface electromyography analysis of tibialis anterior muscle, dynamic balance and lower limb recovery in chronic stroke patients with foot drop. |