Home » Trials » SLCTR/2023/011
Effectiveness of a task specific trunk movement training exercise protocol in rehabilitation of infants and children with high predictive value of cerebral palsy
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SLCTR Registration Number
SLCTR/2023/011
Date of Registration
The date of last modification
Jun 16, 2023
Scientific Title of Trial
Effectiveness of a task specific trunk movement training exercise protocol in rehabilitation of infants and children with high predictive value of cerebral palsy
Public Title of Trial
Comparison of the effectiveness of a task specific trunk movement training exercise protocol to routine physiotherapy in rehabilitation of infants and children with high predictive value of cerebral palsy
Disease or Health Condition(s) Studied
Children with high risk of cerebral palsy
Scientific Acronym
None
Public Acronym
None
Brief title
Exercise protocol in rehabilitation of children with high predictive value of cerebral palsy
Universal Trial Number
U1111 1290 4495
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Will the addition of a task specific trunk movement training be an effective exercise protocol compared to a routine exercise programme in rehabilitation of infants and children with high predictive value of cerebral palsy.
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Outcome assessors
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
Intervention(s) planned
Study setting- Colombo South Teaching Hospital, Kothalawela Defence University hospital.
The study population is a high predictive value group.The infants are assessed with General movement and Hammersmith Infant Neurological Examination score (HINE) and CT scan and are predicted at the risk of developing cerebral palsy by the paediatric neurologist.
All the children will be recruited into two groups namely group A (control) and group B (interventional), by using excel generated random numbers (random number method) and concealment method will be used, using a closed cover envelope.
Group A (control) will be continuing with the same routine physiotherapy exercises plan currently undergoing such as mobility training, strength training, physical activity, play therapy, postural management for 45 minutes, one session per day, one day in a week.
Group B (interventional) will be continuing with the same routine physiotherapy exercises plan currently undergoing such as mobility training, strength training, physical activity, play therapy, postural management and in addition, the task specific trunk movement training exercise protocol designed for analysis in this study for 45 minutes, one session per day, one day in a week.
The evaluator will be blinded and uses the outcome measures used in the study to all the participants (Group A and Group B).
Inclusion criteria
Infants and Children with high predictive value of cerebral palsy as adjudged by a paediatric neurologist using a combination of, The General Movement Assessment, Hammersmith Infant Neurological Examination score (HINE) of 40- 57 and CT scan findings
Infants and Children between 6 months to 24 months. Infants and Children with (with neck control). Both male and female.
Exclusion criteria
Infants and Children with poor neck control as assessed by a pediatric neurologist. Infants and children with HINE score less than 40. Infants and Children with other conditions that may interfere with the study (Congenital deformities and severe cognitive impairment.
Primary outcome(s)
1.
Gross motor function measure score The Trunk control measures scale |
[ Baseline and end of treatment ] |
Secondary outcome(s)
1.
None |
[] |
Target number/sample size
54
Countries of recruitment
Sri Lanka
Anticipated start date
2023-05-10
Anticipated end date
2024-03-31
Date of first enrollment
2023-04-05
Date of study completion
Recruitment status
Recruiting
Funding source
self funded
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2022-07-21
Approval number
1051
Details of Ethics Review Committee
Name: | S.Sukirthan |
Institutional Address: | Colombo south teaching hospital, kalubowila, Dehiwala , Srilanka. |
Telephone: | 0112763261-62 |
Email: | hospcolsouth@sltnet.lk |
Contact person for Scientific Queries/Principal Investigator
S. Sukirthan
Lecturer- physiotherapy
General Sir John Kotelawala Defence University
0710644895
0710644895
sukirthan11@yahoo.com
Contact Person for Public Queries
Dr SP Senanayake
Senior Lecturer
General Sir john Kotelawala Defence University
0710644895
0776015333
sameerapeumal@gmail.com
Primary study sponsor/organization
General Sir john Kotelawala Defence University
Kandawala Road, Dehiwala-Mount Lavinia
https://kdu.ac.lk/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results