| CTRI Number |
CTRI/2024/11/076228 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Benefits of Art Therapy and Task-Oriented Training in Improving Balance and Quality of Life of Children with Cerebral Palsy. |
|
Scientific Title of Study
|
Effect of Art therapy and Task-Oriented training in improving quality of life and balance in children with cerebral palsy : A Pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suhana Shoyeb |
| Designation |
student |
| Affiliation |
Galgotias University |
| Address |
Room no E-005 Department of physiotherapy Galgotias University Plot No.2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7042314059 |
| Fax |
|
| Email |
physiotherapistsuhana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Narendra kumar |
| Designation |
assistant professor |
| Affiliation |
galgotiasuniversity |
| Address |
Room no B512 School of allied health sciences department of physiotherapy Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8447767591 |
| Fax |
|
| Email |
narendrakumargims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Narendra kumar |
| Designation |
assistant professor |
| Affiliation |
galgotiasuniversity |
| Address |
Room no B512 School of allied health sciences department of physiotherapy Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8447767591 |
| Fax |
|
| Email |
narendrakumargims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research and Development Cell, Galgotias University , Plot no 2, sector 17A, Yamuna Expy, opposite Buddha International Circuit, Greater Noida, Uttar Pradesh, 2032021 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Plot No.2 Sector 17-A, Opposite Buddha International Circuit, Yamuna Expressway, Greater Noida, India |
| Type of Sponsor |
Research institution |
|
|
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 |
| Suhana Shoyeb |
Galgotias University |
Room No. E005, Department of Physiotherapy, School of Allied Health Science, Galgotias University, Opposite Buddha International Circuit, Gautam Buddha Nagar, Uttar Pradesh .
Gautam Buddha Nagar
UTTAR PRADESH |
7042314059
physiotherapistsuhana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee Galgotias University |
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 |
Art Therapy and Task-Oriented Training |
Art Therapy : Includes activities like coloring, drawing, tracing figures, vegetables or thumb printing to improve fine motor skills , emotional well-being and overall quality of life.
Task-Oriented Training : Includes ball throwing and catching, target practice, ring toss, and obstacle courses to enhance motor control, coordination and balance.
frequency and duration: 3 sessions per week, each lasting 60 minutes, for 6 weeks. |
| Comparator Agent |
Conventional Physiotherapy |
Conventional Therapy : Includes standard physiotherapy techniques which includes stretching, strengthening, and balance training focused on improving motor skills, balance, and coordination .
frequency and duration: 3 sessions per week, each lasting 60 minutes, for a total of 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
6-13 years of male and female children with cerebral palsy , having ability to follow basic instructions. |
|
| ExclusionCriteria |
| Details |
1. Severe cognitive impairments
2. Completely dependent children.
3. Recent surgeries or medical history |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pediatric Balance Scale |
1. Pre-intervention assessment ( at the baseline )
2. Post-intervention ( immediately after 6 weeks of intervention ) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pediatric Quality of Life Inventory |
1. pre-intervention assessment ( at the baseline )
2. post-intervention assessment ( immediately after 6-week intervention. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
06/11/2024 |
| 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="0"
Months="1"
Days="15" |
|
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
|
This research study aims to investigate the effects of art therapy and task-oriented training on improving balance and quality of life in children with cerebral palsy (CP). CP is a prevalent motor disability in children, affecting movement, coordination, and overall quality of life. Conventional physiotherapy often focuses primarily on motor function improvements, but combining art therapy with task-oriented training may offer a more holistic approach.
The study will involve 22 children with CP, aged 6 to 13 years, divided equally into two groups. The experimental group will receive art therapy and task-oriented training, which includes activities such as coloring, drawing, ball throwing, and obstacle courses. The control group will receive conventional physiotherapy, focusing on stretching, strengthening, and balance exercises.
The study will last for 6 weeks, with 3 sessions per week, each session lasting 60 minutes. The primary outcome will be measured using the Pediatric Balance Scale (PBS) to assess balance improvements. The secondary outcome will evaluate the quality of life using the Pediatric Quality of Life Inventory (PedsQL).
The objective is to determine whether the combination of art therapy and task-oriented training provides significant improvements in balance and quality of life compared to conventional therapy. The study is expected to provide valuable insights into improving therapeutic approaches for children with cerebral palsy. |