| CTRI Number |
CTRI/2023/02/049582 [Registered on: 09/02/2023] Trial Registered Prospectively |
| Last Modified On: |
15/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Kinesio Taping on Oral function in children |
|
Scientific Title of Study
|
Effect of Kinesio taping on Oromotor Dysfunction in children with Spastic Cerebral Palsy in the age group of 3-12 years- a Quasi Experimental study. |
| Trial Acronym |
KT CP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Miss Vaishnavi Sunil Daptare |
| Designation |
Postgraduation Student |
| Affiliation |
Deccan Education Societys Brijlal Jindal college of physiotherapy |
| Address |
Deccan Education Societys Brijlal Jindal college of Physiotherapy
Fergusson college campus, Shivaji Nagar, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
7057669844 |
| Fax |
|
| Email |
umavaishnavi55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harshada sonawane |
| Designation |
Associate Professor |
| Affiliation |
Deccan Education Societys Brijlal Jindal college of physiotherapy |
| Address |
Deccan Education Societys Brijlal Jindal college of Physiotherapy
Fergusson college campus, Shivaji Nagar, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
9545256163 |
| Fax |
|
| Email |
harshadaa.dk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshada sonawane |
| Designation |
Associate Professor |
| Affiliation |
Deccan Education Societys Brijlal Jindal college of physiotherapy |
| Address |
Deccan Education Societys Brijlal Jindal college of Physiotherapy
Fergusson college campus, Shivaji Nagar, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
9545256163 |
| Fax |
|
| Email |
harshadaa.dk@gmail.com |
|
|
Source of Monetary or Material Support
|
| DES BRIJLAL JINDAL COLLEGE OF PHYSIOTHERAPY, PUNE |
|
|
Primary Sponsor
|
| Name |
Harshada Sonawane |
| Address |
1002, Karan tej , Arista Pune Bangalore highway Warje Pune |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harshada Sonawane |
DES Brijlal Jindal college of physiotherapy |
Physiotherapy Department Fergusson college campus Shivaji Nagar Pune
Pune
MAHARASHTRA |
9545256163
harshadaa.dk@gmail.com |
| Ms Vaishnavi Daptare |
DES Brijlal Jindal college of physiotherapy |
PHYSIOTHERAPY DEPARTMENT, FERGUSSON college campus, Shivaji Nagar Pune
Pune
MAHARASHTRA |
7057669844
umavaishnavi55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DES Brijlal Jindal college of physiotherapy Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G809||Cerebral palsy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kinesio Taping |
3 sessions of kinesio Taping for 1 week |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children diagnosed with spastic cerebral palsy having oromotor dysfunction.
2. Both male and female.
3. Age 3-12 years |
|
| ExclusionCriteria |
| Details |
1. Children undergoing any other treatment strategy for oromotor dysfunction (like sensorimotor stimulation, MFR , neuromotor facilitation).
2. History of Botulinum Toxin A injection.
3. Uncorrected or corrected cleft palate, cleft lips.
4. open wound around lips or face.
5. Skin allergies. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Orofacial Motor function Assessment Scale
Oral motor function assessment scale
Vernier Calliper |
Baseline and at the end of the intervention (Two time points) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/02/2023 |
| Date of Study Completion (India) |
24/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
24/07/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In this quasi experimental study the effect of Kinesio Taping on Oromotor function in children with Spastic Cerebral Palsy was seen. The children who met the inclusion criteria received treatment with Kinesio Tape for a week. The effect was assessed using OMAS, OFMFAS and mouth opening using Vernier Caliper. Results were analyzed using wilcoxon signed rank test (for OMAS and OFMFAS)and paired t test( for vernier caliper). At P value <0.05, the results were found statistically significant. thus the intervention was found effective in improving oromotor dysfunction in children with Spastic Cerebral Palsy. |