Home » Trials » SLCTR/2021/035
LEAP-CP ( Learning through Everyday Activities with the Parents of Children with Cerebral Palsy)
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SLCTR Registration Number
SLCTR/2021/035
Date of Registration
The date of last modification
Dec 11, 2021
Scientific Title of Trial
LEAP-CP ( Learning through Everyday Activities with the Parents of Children with Cerebral Palsy)
Public Title of Trial
The motor, social emotional and cognitive outcomes of infant at risk of neuromotor impairment disability, receiving Learning through Everyday Activities with the Parents of Children with Cerebral Palsy (LEAP-CP) programme and standard care: A randomized control trial
Disease or Health Condition(s) Studied
Cerebral Palsy
Scientific Acronym
LEAP-CP
Public Acronym
LEAP-CP study
Brief title
Early Detection, Surveillance, and Home-based early intervention for families with infants at risk of neuro-motor disabilities: implementation of evidence based guidelines into clinical care
Universal Trial Number
U1111-1271-0146
Any other number(s) assigned to the trial and issuing authority
P/55/09/2020
What is the research question being addressed?
How effective is a programme on early detection, surveillance, and home-based early intervention on the motor, social emotional and cognitive outcomes of infant at risk of neuromotor impairment disability compared to standard therapy?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Investigators, Data analysts, Outcome assessors
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
Study setting: 1. Cerebral Palsy Lanka Foundation (CPLF), Sri Lanka, 2. Ayati National Center for Children with Disabilities. Method of randomization: Cluster-randomized using central concealed random allocation to receive either the LEAP-CP (CPLF) or care as usual (CAU). Participant and researchers assessing the outcomes and analyzing the data will be masked to group allocation. Details of the intervention: A multi-domain best practice intervention consisting of responsive parenting, infant goal-directed therapeutic learning games, and caregiver educational modules, based on efficacy shown in systematic reviews and Early Intervention trials (Learning through Everyday Activities with Parents of children with CP).Goal-directed skill training includes motivating infant-generated activities practiced to optimize learning; using principles of structure, repetition, and variation. Functional motor skills, such as reach/ grasp and attaining anti-gravity postures, will be coached, and parents given visual supports (photo/ video) for ongoing practice through the week. Intervention will be provided from 3-6 months for 30 weeks. Public Health Midwives and health professionals visit the families’ minimum of 6 visits per year to follow up on growth and development.
Inclusion criteria
Infants aged 3 months to <6 months identified as at high-risk of CP: • Extremely preterm (gestational age <28 weeks) • Extremely low birthweight (birth weight <1000 g) • Neonatal encephalopathy • Neurological risk factors (e.g. congenital disabilities, seizures, stroke) • General Movements “Absent fidgety” score + abnormal brain MRI/CUS indicating cerebral palsy; • General Movements “Absent fidgety” score + Hammersmith Infant Neurological Evaluation (HINE) score <57 at 12-weeks / <59 26-weeks of age; • Abnormal brain MRI/CUS indicating cerebral palsy + Hammersmith Infant Neurological Evaluation score <57 at 3 months of age/ <59 at 6 months of age. (infants with evidence of unilateral injury and clinical asymmetry indicating hemiplegia, HINE scores > 57 will be accepted as per literature).
Exclusion criteria
• Infants with lethal abnormalities • Infants with congenital conditions not associated with cerebral palsy (e.g. Down’s Syndrome) Infants with complex medical conditions requiring acute medical care
Primary outcome(s)
|
1.
The mean score differences in Peabody Developmental Motor Scales, edition 2 (PDMS-2). The assessment is composed of six subtests that measure interrelated motor abilities that develop early in life. |
[ Pre-intervention (T0) Postintervention T1=baseline age + 30 weeks T2 = 18 months corrected age ] |
|
2.
The mean score differences in Toddler Social Emotional Assessment (ITSEA). The tool measures multiple dimensions of social-emotional problems and competencies. |
[ Pre-intervention (T0) Postintervention T1=baseline age + 30 weeks T2 = 18 months corrected age ] |
|
3.
The primary caregiver outcome will be assessed through the Depression, Anxiety, Stress Scale – Short Form (DASS). DASS is a 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress. |
[ Pre-intervention (T0) Postintervention T1=baseline age + 30 weeks T2 = 18 months corrected age ] |
Secondary outcome(s)
|
1.
Mean score difference in Emotional Availability Scales (EAS), Emotional Availability-Self Report (EA-SR) and the Infant Toddler Quality of Life Questionnaire TM (ITQOL-SF47). These tools will assess behavioral and emotional problems of the study participants. |
[ Pre-intervention (T0) Postintervention T1=baseline age + 30 weeks T2 = 18 months corrected age ] |
|
2.
Mean score differences in the following tools which assesses functional outcomes of the participants: Canadian Occupational Performance Measure (COPM), the Pediatric Evaluation of Disability Inventory – Computer Adaptive Test (PEDI-CAT), the Bayley Scales of Infant Development III (BSID-III) and the Preverbal Visual Assessment (PreVIAS). |
[ Pre-intervention (T0) Postintervention T1=baseline age + 30 weeks T2 = 18 months corrected age ] |
Target number/sample size
86 participants (43 in each arm)
Countries of recruitment
Australia, Georgia, Sri Lanka
Anticipated start date
2022-01-15
Anticipated end date
2024-01-15
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
European Commission Multi-beneficiary Model Project GA 848201 as part of the H2020 programme with the acronym BORNTOGETTHERE (Grant number 848201)
Regulatory approvals
Status
Approved
Date of Approval
2021-09-14
Approval number
P/55/09/2020
Details of Ethics Review Committee
| Name: | Ethics Review Committee |
| Institutional Address: | Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka |
| Telephone: | 0112961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Gopi Kitnasamy
Head of Rehabilitation Services
MJF Charitable Foundation
111 Negombo Road
Peliyagoda
+94777554328
+94714342247
gopi291975@yahoo.com
Contact Person for Public Queries
Prof. Samanmali Sumanasena
Professor in Paediatric Disabilities
Department of Disability Studies
Faculty of Medicine
University of Kelaniya
+94112958251
+94777256768
samanmalis@yahoo.com
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
