Clinical Trial: Early Intervention in Infants With Perinatal Stroke

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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 moto
Sponsor: University Ghent

Current Primary Outcome:

• 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.
• 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
• 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.
• 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.
• 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.

Original Secondary Outcome: Same as current

Information By: University Ghent

Dates:
Date Received: March 2, 2016
Date Started: June 29, 2016
Date Completion: March 2020
Last Updated: May 4, 2017
Last Verified: May 2017