Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2016-06-29
2020-03-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
CIMT
Constraint-induced movement therapy
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.
HABIT
hand-arm bimanual intensive training
Baby-massage
3 sessions of baby-massage will be given by a qualified instructor
baby-massage
instructions for baby-massage
Interventions
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CIMT
Constraint-induced movement therapy
HABIT
hand-arm bimanual intensive training
baby-massage
instructions for baby-massage
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
4 Months
8 Months
ALL
No
Sponsors
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University Ghent
OTHER
Responsible Party
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Principal Investigators
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Paul Govaert, Dr
Role: PRINCIPAL_INVESTIGATOR
Universiteit Gent, vakgroep REVAKI
Locations
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Ghent University
Ghent, , Belgium
Countries
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Other Identifiers
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2015/1299
Identifier Type: -
Identifier Source: org_study_id