| CTRI Number |
CTRI/2024/06/068468 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| 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 Constraint Induced Movement Therapy and Kinesio Taping on Spasticity, Grip Strength and Hand Function in stroke patients |
|
Scientific Title of Study
|
Effect of Constraint Induced Movement Therapy and Kinesio Taping on Spasticity, Grip Strength and Hand Function in Post-Stroke Patients: A Randomized Controlled 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 |
Tuhina Shee |
| Designation |
M.P.T |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy, Pimpri,Pune |
| Address |
Dr. D. Y. Patil College of Physiotherapy,Dr D .Y .Patil Vidhyapeeth ,Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7367965095 |
| Fax |
|
| Email |
tuhinashee294@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Gazbare |
| Designation |
Professor |
| Affiliation |
Dr. D Y patil college of physiotherapy |
| Address |
Dr. D. Y. Patil College of Physiotherapy,Dr D .Y .Patil Vidhyapeeth ,Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9096116134 |
| Fax |
|
| Email |
preeti.gazbare@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Gazbare |
| Designation |
Professor |
| Affiliation |
Dr. D Y patil college of physiotherapy |
| Address |
Dr. D. Y. Patil College of Physiotherapy,Dr D .Y .Patil Vidhyapeeth ,Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9096116134 |
| Fax |
|
| Email |
preeti.gazbare@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tuhina Shee |
| Address |
Dr. D. Y. Patil College of Physiotherapy,Dr D .Y .Patil Vidhyapeeth , Neurophysiotherapy department, floor no. 3, room no. 3.Sant Tukaram Nagar, Pimpri, Pune. 411018 |
| 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 Preeti Gazbare |
Dr. D. Y. Patil College of Physiotherapy. |
DR. D. Y. Patil
College of
Physiotherapy, Neuro department, floor no. 3 room no. 3.
Sant Tukaram
Nagar, Pimpri,
Pune,
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9096116134
preeti.gazbare@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of Dr. D. Y. Patil college of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kinesio Taping and conventional neurophysiotherapy |
The flexor and extensor aspects of the wrist musculature will be taped using inhibition and facilitation techniques. KT will be applied using the origin to insertion technique for facilitation on the extensor aspect and insertion to origin technique for inhibition on the flexor aspect. For the inhibition technique, the tape will be applied from the dorsum of the head of the metacarpal by entering the fingers in the cuts made in the tape. Then the tape was applied around the wrist flexor muscles, from the head of the metacarpals to the medial epicondyle of the Humerus on the affected hand. The elbow will be maintained in full extension during the application, forearm supination, and wrist in full extension. For the facilitation technique, the tape application begins from the lateral epicondyle and covered the target muscle to the tips of all four fingers. At the level of the wrist joint, the tape will be cut into four strips for all fingers and then taped over it. Tape will be applied with elbow maintained in extension, forearm in pronation, and wrist and finger flexion. Tape will be changed after every 2 days. For Conventional Neurophysiotherapyexercises given to improve To reduce spasticityTo improve flexibility and joint integrity Improvestrength Improve locomotion Improve ADLs |
| Intervention |
Modified constraint induced movement therapy and conventional neurophysiotherapy |
Apply the constraint mitt or cast to the unaffected limb, rendering it immobile. Ensure the constraint is comfortable and secure, avoiding excessive pressure or discomfort. Schedule 4 days per week for 4 weeks therapy sessions with a defined duration (typically 3 hours per day). During each session, engage the patient in various upper limb exercises and functional tasks (Table 1), progressively increasing difficulty. We will encourage the patient to use the affected limb to the best of their ability for all activities. We will use objects of different sizes, shapes, and textures to challenge motor skills and set some specific goals for each session and document progress. The patient is asked to sit on the chair with back support. The patients unaffected hand will be tied with a triangular bandage or splint and the patient asks to perform the exercise through the affected hand. For Conventional Neurophysiotherapyexercises given to improve To reduce spasticityTo improve flexibility and joint integrity Improvestrength Improve locomotion Improve ADLs |
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have been diagnosed with Stroke.
Brunnstrom recovery stage for upper limb above 3.
Both gender Male and female
MMSE score more than 23/18.
|
|
| ExclusionCriteria |
| Details |
Bilateral stroke.
Recent injury like upper limb fracture, nerve injury etc.
Congenital deformities of upper limb like Radial Club hand, Ulnar Club hand, Polydactyly etc.
Other neurological conditions like Parkinson’s, Multiple sclerosis, Motor neuron disease.
Age below 22 years and more than 70 years.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Modified Modified Ashworth Scale (Spasticity)
2) Dynamometer (Grip strength)
3) Wolf Motor Function Test (Motor Function)
|
1) At the beginning of the study.
2) At the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
14/06/2024 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 aims to investigate the effects of KT and mCIMT
in two groups separately. Several researches have presented combined effect of
KT and mCIMT but there has been very limited studies where they have compared
these two approaches with conventional treatment mainly on the function and
reduction of spasticity of upper extremity. Taping consists of an adjunct
technique, which uses an elastic adhesive tape over the skin in order to
stimulate Mechano receptors via continuous skin Stretching and compression
during joint motion. Based on accepted principles in neuroscience, it can be
hypothesized that these afferent stimuli are transmitted to the contralateral
area of the somatosensory cortex, which integrates information from different
sensory and motor modalities. CIMT reduces the degree of spasticity as a result
of neuro motor rehabilitation via intensive and repetitive tasks. There were no
control group added in the previous studies.The physiology behind mCIMT and KT are different but the effects
of the two approaches are more or less same, this study aims to investigate the
better treatment option for upper limb function and spasticity reduction in
post-stroke hemiplegia. mCIMT has been mostly done on toddlers, very limited
study shows the significant results about the Post stroke hemiplegia ,this study
mainly focuses on upper limb function and spasticity reduction and grip
strength. |