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

04 May 2023

The date of last modification

Jun 16, 2023



Application Summary


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


Trial Details


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



State of Ethics Review Approval


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 & Sponsor Information


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/

Secondary study sponsor (If any)







Trial Completion details


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