| CTRI Number |
CTRI/2024/07/071235 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Imroving Feeding and Mealtime behaviour in children with Cerebral palsy using Global Intensive Feeding Therapy |
|
Scientific Title of Study
|
EFFECT OF GLOBAL INTENSIVE FEEDING THERAPY (GIFT) ON FEEDING AND MEALTIME BEHAVIOUR IN CHILDREN WITH CEREBRAL PALSY- 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 |
SHREYA MALLIKARJUN BAVI |
| Designation |
Post Graduate student |
| Affiliation |
KAHER Institute of Physiotherapy, Belgaum |
| Address |
Advanced Physiotherapy center, room no 39, sagar floor, KLE Dr
prabhakar kore Hospital Belgaum
Karnataka 590010 India
Advanced Physiotherapy center, room no 39, sagar floor, KLE Dr
prabhakar kore Hospital Belgaum
Karnataka 590010 India
Belgaum
KARNATAKA
590010
India |
| Phone |
7420876067 |
| Fax |
|
| Email |
shreya682000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinuta Deshpande |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center, room no 39 sagar floor KLE Dr
prabhakar kore Hospital Belgaum Karnataka 590010 Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
8754466612 |
| Fax |
|
| Email |
vinuta.gangavatikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHREYA MALLIKARJUN BAVI |
| Designation |
Post Graduate student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center, room no 39, sagar floor, KLE Dr
prabhakar kore Hospital Belgaum
Karnataka 590010 India
Belgaum
KARNATAKA
590010
India |
| Phone |
7420876067 |
| Fax |
|
| Email |
shreya682000@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar kore hospital and research center, Nehru nagar Belagavi Karnataka 590010 |
|
|
Primary Sponsor
|
| Name |
Shreya Bavi |
| Address |
Sagar Floor, Advanced Physiotherapy Centre, Room no 39, KLE
Dr.Prabhakar Kore Hospital and MRC, Belagavi,Karnataka, 590010 |
| Type of Sponsor |
Other [self-sponsored] |
|
|
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 |
| DrShreya Bavi |
KLE Dr.Prabhakar Kore Hospital and MRC Belagavi, |
Advanced
Physiotherapy center,
room no 39, sagar floor,
KLE Dr prabhakar kore
Hospital Belgaum
Karnataka 590010
Belgaum Karnataka
590010 India
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
7420876067
shreya682000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Comittee KAHER Institute of Physiotherapy |
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 |
| Comparator Agent |
Conventional oromotor exercises |
Active and passive oromotor exercises with sensory training |
| Intervention |
Global Intensive Feeding Therapy(GIFT) |
The protocol consists of:
1.Systematic desensitization and gradual exposure
2.Food Repertoire
3.Behavioral problems during mealtime
4.Chewing and Swallowing Abilities
5.Parent training
Duration- 3times/day for 5 days in a week for 2 consecutive
weeks(30 session)
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.All gender children diagnosed with CP aged between 1-10 years
2.Score of 0-2 on initial assessment of OMAS
3.Children fed orally
4.Age of mother more than 19 years, able to comprehend and follow intervention/instruction in vernacular language
|
|
| ExclusionCriteria |
| Details |
1. Children with cleft lip and palate; gum infections and congenital problems of mouth and soft palate
2. Children with uncontrolled seizures
3. Children diagnosed with any metabolic, cardiopulmonary, gastrointestinal disorders and other neurological impairments
4. Caregivers unable to comply with research procedures and hospital visit after 2 weeks.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Oral Motor Assessment Scale(OMAS)
2.Behavioural Pediatrics Feeding Assessment Scale(BPFAS) |
T1- baseline
T2- post-intervention(after 2 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/08/2024 |
| Date of Study Completion (India) |
25/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Many children with cerebral palsy experience and struggle with feeding problems, which can lead to issues like poor growth, difficulty eating and frequent respiratory illnesses. These challenges are often due to sensory and motor issues which can make the mealtime frustrating for both the child and their family. Behavioural issues such as food refusal, gagging, and vomiting are common. Commonly used treatment for these children are the oromotor exercises but, they have limited scientific proof of effectiveness. A new program called GIFT (Global Intensive Feeding Therapy) will help in improving feeding skills in these children, and this study will assess its impact on feeding and mealtime behaviour.The children will be recruited and study will be explained to the parents.Demographic data will be recorded and pre-treatment assessment of feeding and mealtime behaviour will be done. Children in the Experimental group will be undergoing intensive rehabilitation i.e Global Intensive Feeding Therapy (GIFT). The intensive training will be performed by the therapist. Parents will be trained with specific techniques to use at home to help your child to generalize feeding abilities and mealtime behaviour during the first session. Control group will be undergoing Conventional oromotor exercises. Both the groups will be receiving the treatment 3times/day for 5 days in a week for 2 consecutive weeks. Outcome measures will be evaluated after the two-week treatment period and results will be calculated. |