Clinical trial NCT02720432: Early Intervention in Infants With Perinatal Stroke
Official title: Early Intervention in Infants With Perinatal Stroke : CIMT Versus HABIT : a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: early intervention, infant
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This current study proposes to analyze the feasibility and effects of the two most used therapies, constraint-induced movement therapy and hand-arm bimanual intensive training, in very young infants (less than one year) with perinatal stroke and with a high risk to develop hemiplegic CP.

Detailed description: Perinatal stroke constitutes an acute presentation of encephalopathy; manifesting as seizure, altered mental status, and/or neurological deficit; between birth and the twenty-eight postnatal day for which a pattern of ischemic brain injury in an arterial distribution is evident by neuroimaging. Following perinatal stroke, approximately 60% of children develop cerebral palsy (usually presenting as spastic hemiplegia), 30-60% experience epilepsy, 25% show language delay, and up to 22% manifest behavioral problems.

The current most predictive tools for early diagnosis of CP are a combination of brain MRI/cUS and a general movements (GM) assessment in the fidgety period (9). Asymmetry of fidgety GMs around 12 weeks post term can be the first clinical signs of hemiplegia.

There are currently two intensive therapy approaches aiming at improving upper limb performance in adults and children (average age 8 years) with established hemiplegic CP: constraint induced movement therapy (CIMT) and Hand-arm bimanual intensive training (HABIT). Those current therapy approaches fundamentally comprise repeated practice of desired movements based on motor learning principles with the adult/ child as an active participant.

Both therapies, in adults and in children with established hemiplegic CP (average age 8 years) are effective and show similar improvements if the dosage of therapy is similar. In contrast, the feasibility and the effects of both therapy approaches at very young age (under age 1 year) is still unknown (22). Exploring these options to treat even before asymmetric hand use has appeared is interesting and promising enough since recent animal studies have demonstrated that there is a critical period of motor system plasticity, and that activity-dependent reorganization of the motor-projection pattern to the hand occurs before about 1 year of age

Eligibility criteria: Inclusion Criteria:

* Infants with a perinatal stroke confirmed on neonatal imaging and from who the parents speaks Dutch and live in Belgium, will be included in the study. Only infants showing abnormal 'general movements' between 10 and 15 weeks will be eligible for the intervention part.

Exclusion Criteria:

* Infants with severe genetic abnormalities or malformations, with severe visual impairments or with uncontrolled seizures will be excluded.

Primary outcomes:
measure: Change in the score of the Hand assessment for infants (HAI)
timeFrame: before (around 4 months) and after 18 weeks of intervention (around 9 months)
measure: Change in the score of the Infant motor profile
timeFrame: before (around 4 months) and after 18 weeks of intervention (around 9 months), at one year follow up
measure: Change in the score of the Alberta infant motor scale
timeFrame: before (around 4 months) and after 18 weeks of intervention (around 9 months), at one year follow up
Secondary outcomes:
measure: Bayley scales for infant development-third edition
timeFrame: between 22 and 24 months (2 years)
measure: Parental sense of competence scale
timeFrame: before intervention (around 4months)
measure: Questionnaire satisfaction and impact
timeFrame: after the intervention (around 9 months)
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
Study officials:
affiliation: Universiteit Gent, vakgroep REVAKI
name: Paul Govaert, Dr
role: PRINCIPAL_INVESTIGATOR
References: