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Early Intervention in Infants With Perinatal Stroke

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ClinicalTrials.gov Identifier: NCT02720432
Recruitment Status : Recruiting
First Posted : March 25, 2016
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Vakgroeprevaki, University Ghent

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.

Condition or disease Intervention/treatment Phase
Stroke Other: CIMT Other: HABIT Other: baby-massage Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Intervention in Infants With Perinatal Stroke : CIMT Versus HABIT : a Randomized Clinical Trial
Actual Study Start Date : June 29, 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CIMT

A soft splint or restraint will be posed to best functioning hand of the infant only during the therapy session. Parents will be educated to perform the therapy, which consists of stimulation of reaching and grasping with the hemiplegic arm.

The whole intervention period lasts 18 weeks, separated into 3 blocks of 4 weeks intervention and 2 blocks of 3 weeks of rest. During the intervention weeks parents will perform CIMTfor 30 minutes, 6 days a week.

Other: CIMT
Constraint-induced movement therapy

Experimental: HABIT

No restraint will be implemented and instead of promoting unilateral grasping, bimanual grasping will be stimulated. Toys will be precisely selected to stimulate progressed bimanual grasping. The approach of the therapist and parents remain equal.

The whole intervention period lasts 18 weeks, separated into 3 blocks of 4 weeks intervention and 2 blocks of 3 weeks of rest. During the intervention weeks parents will perform HABIT for 30 minutes, 6 days a week.

Other: HABIT
hand-arm bimanual intensive training

Sham Comparator: Baby-massage
3 sessions of baby-massage will be given by a qualified instructor
Other: baby-massage
instructions for baby-massage




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   4 Months to 8 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02720432


Contacts
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Contact: Aurelie Pascal, drs aurelie.pascal@ugent.be

Locations
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Belgium
Ghent University Recruiting
Ghent, Belgium, 9000
Contact: Aurelie Pascal    93322010      
Principal Investigator: Paul Govaert         
Sponsors and Collaborators
University Ghent
Investigators
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Principal Investigator: Paul Govaert, Dr Universiteit Gent, vakgroep REVAKI

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Responsible Party: Vakgroeprevaki, Paul Govaert, MD, University Ghent
ClinicalTrials.gov Identifier: NCT02720432     History of Changes
Other Study ID Numbers: 2015/1299
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Vakgroeprevaki, University Ghent:
early intervention, infant

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases