About this trial
Using a randomized controlled trial design, in an hospital environment, possible changes induced by the "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" treatment program will be investigated in functional activities of daily living, motor and cognitive assessment of children with acquired brain injury.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
children with acquired brain injury of school
age 5 to 18 years inclusive
Disqualifiers
Unstable seizure
programmed botulinum toxin or orthopedic surgery in the 6 months previous to the intervention, during intervention period or 3months after the intervention time
Severe visual or cognitive impairments likely to interfere with intervention or testing session completion
Trial design
Parallel
Treatments tested in this trial
HABIT-ILE
Behavioral2 weeks HABIT-ILE
Conventional intervention
Behavioral2 weeks usual intervention (waitlist group)
Treatment groups
Trial outcomes
Primary outcomes
Flanker task
Cognitive functions of the children will be assessed by Flanker task.
Changes in Gross Motor Function Measurement (GMFM 66)
The GMFM has been developed to measure the change in gross motor function over time in children with cerebral palsy.
Secondary outcomes
Changes in isometric muscular strength (Jamar)
A quantitative and objective measure of isometric muscular strength of hand and forearm.
Stroop task
Executive functions of the children will be assessed by Stroop task.
Changes in unimanual dexterity: Box and Blocks test (BBT)
The BBT is a test of gross manual dexterity. Each hand is tested individually and the BBT is scored through the number of blocks carried over the partition from one part to another part of a box during the one-minute trial period.
Changes on bimanual function (Assisting Hand Assessment (AHA))
Developed to observe the efficacy of the assisting hand use, in children with unilateral cerebral palsy (scored in percentage), during bimanual activities for the randomized controlled trial
Sponsors and contacts
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