This randomized controlled trial will compare the effects of neuroplastic and functional changes of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) when presented in two periods (2HG; n=24) versus a single period (1HG; n=24) in people with bilateral CP. The 1HG will receive 65 hours of HABIT-ILE over one intervention period; the 2HG will receive 130 hours over two intervention periods, within 6 months apart. Children will be assessed at 6 time points: baseline, three weeks after the start, at 3, 6, 7 and 9 months after the start of the study.
Children with medical diagnosis of bilateral cerebral palsy
Cognitive capacity and language that allows understanding and following the therapist's instructions.
Manual Ability Classification System (MACS) levels I to III
Bimanual Fine Motor Function (BFMF) levels I to III
Severe visual problems
Movement restriction due to orthopedic surgery in less than a year
Treatment with botulinum toxin and/or baclofen pump in the last 6 months
Contraindications to receive transcranial magnetic stimulation (epileptic history, metallic implants, neoplasm, etc.)
Parallel
Hand-Arm Bimanual Intensive Therapy Including Lower Extremities
BehavioralStructured bimanual tasks training, with gradual increase in motor difficulty, requiring increased postural adjustments and the use of the lower extremities.
Hand-Arm Bimanual Intensive Therapy Including Lower Extremities
BehavioralStructured bimanual tasks training, with gradual increase in motor difficulty, requiring increased postural adjustments and the use of the lower extremities.
Changes in Gross Motor Function
The Gross Motor Function Measure is a standardized observational instrument designed to measure changes in gross motor function over time or following an intervention in children and youth with cerebral palsy using Rasch analysis. It is scored on a scale of 0 to 3, where 0 means the person cannot perform the activity and 3 means the person can complete the item. The score is converted to a percentage. A higher percentage means a better gross motor function.
Both Hands Assessment (BoHA)
The Both Hands Assessment is a valid test for children with mild to moderate bilateral manual abilities impairments. It can evaluate bimanual activity performance and the level of upper extremity asymmetry. It rates performance between 1 (does not do) and 4 (effective). The final score is converted to BoHA units (logit 0 - 100), where higher scores reflect better bimanual use.
Melbourne 2 Assessment (MA2)
The Melbourne 2 Assessment (MA2) assesses the unilateral performance of the upper extremities, quantifying the dexterity, fluency, accuracy, and range of movement during several tasks of reaching and manipulation. The result is obtained as a percentage of the function of each item. A higher percentage means a better unilateral performance of the upper extremity.
Test of Arm Selective Control (TASC)
The TASC test assesses the selective voluntary motor control of upper limbs in individuals with cerebral palsy. The participant must execute eight movements in the upper extremity. The execution of each sequence will be assessed on a scale of 0, 1, or 2, from absence, impairment, or normality of voluntary selective motor control, respectively, with a maximum of 16 points per side and 32 points overall.
Selective Control Assessment of the Lower Extremity (SCALE)
The SCALE test assesses the selective voluntary motor control of lower limbs in individuals with cerebral palsy. The participant must execute five movements in the lower extremity. The execution of each sequence will be assessed on a scale of 0, 1 or 2, from absence, impairment, or normality of voluntary selective motor control respectively, with a maximum of 10 points per side and 20 points overall.
Click on the lead sponsor to view all of their trials.
