| CTRI Number |
CTRI/2024/05/067606 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2024 |
| 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
|
Comparing Kinesiotaping Techniques in Children with Spastic CP" |
|
Scientific Title of Study
|
Effectiveness of Facilitatory versus Inhibitory Kinesiotaping Techniques in Lower Limb along with Conventional Therapy on Functional Mobility and Gait Parameters in Children with Spastic Cerebral Palsy |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Kasale |
| Designation |
MPTh |
| Affiliation |
MAEERS College of Physiotherapy Talegaon Dabhade |
| Address |
MAEERS College of Physiotherapy A 230 Neurophysiotherapy department OPD Building 2 nd floor , near Talegaon Dabhade railway station,talegaon Dabhade Pune 410507
Pune
MAHARASHTRA
410507
India |
| Phone |
|
| Fax |
|
| Email |
nehakasale1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya Chitre |
| Designation |
Associate Professor |
| Affiliation |
MAEERS College of Physiotherapy Talegaon Dabhade |
| Address |
MAEERS College of Physiotherapy A 219 cabin OPD Building 2 nd floor , near Talegaon Dabhade railway station,talegaon Dabhade Pune 410507
Pune
MAHARASHTRA
410507
India |
| Phone |
9049998861 |
| Fax |
|
| Email |
priyasatpute@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumitra Sakhawalkar |
| Designation |
Associate Professor |
| Affiliation |
MAEERS College of Physiotherapy Talegaon Dabhade |
| Address |
MAEERS College of Physiotherapy OPD A 218 Cabin Building 2 nd floor , near Talegaon Dabhade railway station,talegaon Dabhade Pune 410507
Pune
MAHARASHTRA
410507
India |
| Phone |
9049998861 |
| Fax |
|
| Email |
sumitra26@mitmimer.com |
|
|
Source of Monetary or Material Support
|
| MAEERS College of Physiotherapy Talegaon Dabhade Pune 410507 |
|
|
Primary Sponsor
|
| Name |
MAEERS College of Physiotherapy Talegaon Dabhade |
| Address |
MAEERS College of Physiotherapy OPD Building 2 nd floor , near Talegaon Dabhade railway station,talegaon Dabhade Pune 410507 |
| 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 Priya Chitre |
MAEERS COLLEGE OF PHYSIOTHERAPY TALEGAON DABHADE PUNE |
MAEERS College of Physiotherapy A 230 Neurophysioltherapy department OPD Building 2 nd floor , near Talegaon Dabhade railway station,talegaon Dabhade Pune 410507
Pune
MAHARASHTRA |
9049998861
priyasatpute@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAEERS college of physiotherapy ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with cerebral palsy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Facilitatory kinesiotaping |
Facilitatory kinesiotaping along with conventional therapy Protocol will be given 4 times a week for 4 weeks |
| Comparator Agent |
Inhibitory kinesiotaping |
Inhibitory kinesiotaping along with conventional therapy
Protocol will be given 4 times a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children diagnosed with spastic cerebral palsy
3 to 18 years age
GMFCS level 2 or 3
Patients should be able to follow the basic verbal commands
Patient should be able to walk 10m with or without orthosis |
|
| ExclusionCriteria |
| Details |
Fixed deformity in their lower limb.
Children allergic to kinesiotape. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| GMFM 88 for Functional mobility |
0 week and 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 10 meter walk test for gait parameter |
0 week and 4 week |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/06/2024 |
| 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="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
|
Cerebral Palsy (CP) is a group of permanent motor disabilities caused by brain lesions, leading to balance and gait disorders due to muscle weaknesses, spasticity, and loss of motor control. Common gait impairments include scissoring, jump knee, and crouch gait, while muscular imbalances affect daily activities. Physiotherapy in CP focuses on improving functional mobility through muscle strengthening, spasticity reduction, gait training, and core stabilization exercises.Kinesiotaping techniques are used to improve gait and functional mobility in CP children, aiming for independence in physiotherapy. While studies show significant effects of kinesiotaping, evidence on its efficacy in cerebral palsy is limited. Research has mostly focused on inhibitory kinesiotaping’s long-term effects on spasticity and mobility, with fewer studies on facilitatory techniques in CP children.The study compares the effectiveness of facilitatory and inhibitory kinesiotaping techniques in improving functional mobility and gait parameters in spastic CP children undergoing physiotherapy rehabilitation. Kinesiotaping is a non-invasive method using special tapes on muscles and joints to reduce spasticity, pain, or activate weakened muscles. Inhibitory kinesiotaping aims to reduce spasticity and stiffness by muscle stretch, while facilitatory techniques improve muscle activation through proprioceptive stimulation and mechanical support.Interventional protocol for 4 weeks – 4 days a week. 2 consecutive days- taping + conventional therepy (taping will be applied for 48hrs) 1 day – no taping ( to allow skin perspiration) 2 consecutive days- taping+ conventional (taping for 48hrs) Tape removal guidance will be given to parents. so that they can remove tape at home . Progression in the conventional therapy will depend on patients improvement. |