Early Intervention in Infants With Perinatal Stroke

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: CIMT; Other: HABIT; Other: baby-massage

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: University Ghent
• Investigators: Principal Investigator: Paul Govaert, Dr, Universiteit Gent, vakgroep REVAKI

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: March 2, 2016
• First Submitted That Met QC Criteria: March 24, 2016
• First Posted (Estimate): March 25, 2016

Study Record Updates

• Last Update Posted (Actual): December 10, 2021
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: early intervention, infant
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2015/1299

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No