Early Intervention in Infants With Perinatal Stroke

Recruiting

Phase N/A Results N/A

Trial Description

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

Conditions

Interventions

  • 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

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

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

Sponsors