Early Intervention in Infants With Perinatal Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02720432
• Other study ID #: 2015/1299
• Status: Completed
• Phase: N/A
• Start date: June 29, 2016
• Est. completion date: March 2020

Study information

• Verified date: December 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2020
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months to 8 Months

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• CIMT
Constraint-induced movement therapy
• HABIT
hand-arm bimanual intensive training
• baby-massage
instructions for baby-massage

Locations

Country	Name	City	State
Belgium	Ghent University	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the score of the Hand assessment for infants (HAI)	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.	before (around 4 months) and after 18 weeks of intervention (around 9 months)
Primary	Change in the score of the Infant motor profile	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	before (around 4 months) and after 18 weeks of intervention (around 9 months), at one year follow up
Primary	Change in the score of the Alberta infant motor scale	The AIMS is a standardized observational scale to assess the gross motor development from birth till independent walking around 18 months of age.	before (around 4 months) and after 18 weeks of intervention (around 9 months), at one year follow up
Secondary	Bayley scales for infant development-third edition	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.	between 22 and 24 months (2 years)
Secondary	Parental sense of competence scale	The parenting Sense of Competence scale is a 16-item Likert-scale questionnaire to measure parent's sense of confidence and satisfaction.	before intervention (around 4months)
Secondary	Questionnaire satisfaction and impact	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.	after the intervention (around 9 months)