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Early Intervention in Infants With Perinatal Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
CIMT
HABIT
baby-massage
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring early intervention, infant

Eligibility Criteria

4 Months - 8 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ghent University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

CIMT

HABIT

Baby-massage

Arm Description

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.

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.

3 sessions of baby-massage will be given by a qualified instructor

Outcomes

Primary Outcome Measures

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.
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
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 2, 2016
Last Updated
December 2, 2021
Sponsor
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT02720432
Brief Title
Early Intervention in Infants With Perinatal Stroke
Official Title
Early Intervention in Infants With Perinatal Stroke : CIMT Versus HABIT : a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 29, 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
early intervention, infant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CIMT
Arm Type
Experimental
Arm Description
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.
Arm Title
HABIT
Arm Type
Experimental
Arm Description
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.
Arm Title
Baby-massage
Arm Type
Sham Comparator
Arm Description
3 sessions of baby-massage will be given by a qualified instructor
Intervention Type
Other
Intervention Name(s)
CIMT
Intervention Description
Constraint-induced movement therapy
Intervention Type
Other
Intervention Name(s)
HABIT
Intervention Description
hand-arm bimanual intensive training
Intervention Type
Other
Intervention Name(s)
baby-massage
Intervention Description
instructions for baby-massage
Primary Outcome Measure Information:
Title
Change in the score of the Hand assessment for infants (HAI)
Description
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.
Time Frame
before (around 4 months) and after 18 weeks of intervention (around 9 months)
Title
Change in the score of the Infant motor profile
Description
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
Time Frame
before (around 4 months) and after 18 weeks of intervention (around 9 months), at one year follow up
Title
Change in the score of the Alberta infant motor scale
Description
The AIMS is a standardized observational scale to assess the gross motor development from birth till independent walking around 18 months of age.
Time Frame
before (around 4 months) and after 18 weeks of intervention (around 9 months), at one year follow up
Secondary Outcome Measure Information:
Title
Bayley scales for infant development-third edition
Description
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.
Time Frame
between 22 and 24 months (2 years)
Title
Parental sense of competence scale
Description
The parenting Sense of Competence scale is a 16-item Likert-scale questionnaire to measure parent's sense of confidence and satisfaction.
Time Frame
before intervention (around 4months)
Title
Questionnaire satisfaction and impact
Description
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.
Time Frame
after the intervention (around 9 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
8 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Govaert, Dr
Organizational Affiliation
Universiteit Gent, vakgroep REVAKI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Early Intervention in Infants With Perinatal Stroke

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