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Completed

NCT Number: NCT02720432

Early Intervention in Infants With Perinatal Stroke

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.

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Key information

Age range

4 month–8 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University

Ghent, 9000, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CIMT

Other

Constraint-induced movement therapy

HABIT

Other

hand-arm bimanual intensive training

baby-massage

Other

instructions for baby-massage

Primary outcomes

  1. Change in the score of the Hand assessment for infants (HAI)

    Time frame: before (around 4 months) and after 18 weeks of intervention (around 9 months)

    The HAI is the very new assessment tool to evaluate the hand function and asymmetry in infants age from 2 till 8 months post term.

  2. Change in the score of the Infant motor profile

    Time frame: before (around 4 months) and after 18 weeks of intervention (around 9 months), at one year follow up

    The IMP is a video-based assessment to evaluate the spontaneous motor behavior of infants from 3 months till independent walking around 18 months of age

  3. Change in the score of the Alberta infant motor scale

    Time frame: before (around 4 months) and after 18 weeks of intervention (around 9 months), at one year follow up

    The AIMS is a standardized observational scale to assess the gross motor development from birth till independent walking around 18 months of age.

Secondary outcomes

  1. Bayley scales for infant development-third edition

    Time frame: between 22 and 24 months (2 years)

    The Bayley Scales of Infant and Toddler Development, Third is a validated and extensively used developmental scale for assessing the cognitive, language and motor development from 1 month till 42 months of age.

  2. Parental sense of competence scale

    Time frame: before intervention (around 4months)

    The parenting Sense of Competence scale is a 16-item Likert-scale questionnaire to measure parent's sense of confidence and satisfaction.

  3. Questionnaire satisfaction and impact

    Time frame: after the intervention (around 9 months)

    A questionnaire will be filled out by the parents at the end of the therapy. They will be asked about the satisfaction of the therapy and therapist.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

Early Intervention in Infants With Perinatal Stroke : CIMT Versus HABIT : a Randomized Clinical Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Mar 25, 2016
Registry last updated
Dec 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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