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.
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
- HABIT Other
Intervention Desc: hand-arm bimanual intensive training ARM 1: Kind: Experimental Label: HABIT 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.
- CIMT Other
Intervention Desc: Constraint-induced movement therapy ARM 1: Kind: Experimental Label: CIMT 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.
- Baby-massage Other
Intervention Desc: instructions for baby-massage ARM 1: Kind: Experimental Label: Baby-massage Description: 3 sessions of baby-massage will be given by a qualified instructor
- Allocation: Randomized
- Masking: Single Blind (Outcomes Assessor)
- Purpose: Treatment
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Change in the score of the Hand assessment for infants (HAI)||before (around 4 months) and after 18 weeks of intervention (around 9 months)||Yes|
|Primary||Change in the score of the Infant motor profile||before (around 4 months) and after 18 weeks of intervention (around 9 months), at one year follow up||Yes|
|Primary||Change in the score of the Alberta infant motor scale||before (around 4 months) and after 18 weeks of intervention (around 9 months), at one year follow up||Yes|
|Secondary||Bayley scales for infant development-third edition||between 22 and 24 months (2 years)||Yes|
|Secondary||Parental sense of competence scale||before intervention (around 4months)||Yes|
|Secondary||Questionnaire satisfaction and impact||after the intervention (around 9 months)||Yes|
- University Ghent Lead