Clinical trial NCT05900778: Implementation of a HABIT-ILE Intervention at William Lennox Neurological Hospital (NeuREHA)
Official title: Implementation of a HABIT-ILE Intervention at William Lennox Neurological : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acquired Brain Injury
Keywords: motor skill learning
executive function
activity of daily living
intensive therapy
acquired brain injury
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The aim is to investigate, for the first time, the effectiveness of HABIT-ILE therapy in a hospital setting in the treatment of a population representative of the clinical population with children with acquired brain injuries.

The hypothesis is that an in-hospital HABIT-ILE protocol will be more effective than conventional therapies usually given to children with acquired brain injury, and that this difference will be objectively demonstrated by clinical assessments of motor function, cognition and participation conducted before and after treatment periods.

The aim of the study is therefore to evaluate the effect of intensive bimanual hand-arm therapy including the lower extremities (HABIT-ILE) on body functions and structures, activity and participation in children with acquired brain injury.

Eligibility criteria: Inclusion Criteria:

* children with acquired brain injury of school
* age 5 to 18 years inclusive

Exclusion Criteria:

* 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

Primary outcomes:
measure: Flanker task
timeFrame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
measure: Changes in Gross Motor Function Measurement (GMFM 66)
timeFrame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Secondary outcomes:
measure: Changes in isometric muscular strength (Jamar)
timeFrame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
measure: Stroop task
timeFrame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
measure: Changes in unimanual dexterity: Box and Blocks test (BBT)
timeFrame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
measure: Changes on bimanual function (Assisting Hand Assessment (AHA))
timeFrame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
measure: Changes in 6 Minutes Walking Test (6MWT)
timeFrame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
measure: Changes in Pediatric balance scale (PBS)
timeFrame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
measure: Changes in Canadian Occupational Performance Measure (COPM)
timeFrame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
measure: Changes in ACTIVLIM-CP questionnaire
timeFrame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
measure: Changes in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)
timeFrame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
measure: Changes in Pediatric quality of life inventory (PedsQL)
timeFrame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
measure: Changes in Measure of Processes of Care (MPOC-20)
timeFrame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
measure: Status in Wechsler Intelligence Scale for Children-Non verbal short version (WISC)
timeFrame: T0 (baseline)
measure: Classification du niveau moteur: The Gross Motor Function Classification System - Expanded & Revised (GMFCS - E&R)
timeFrame: T0 (baseline)
measure: QUALITY OF LIFE : KIDSCREEN 10
timeFrame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Other outcomes:
Locations:
city: Ottignies-Louvain-la-Neuve
country: Belgium
facility: Centre Hospitalier Neurologique William Lennox
state: Brabant-Wallon
city: Brussels
country: Belgium
facility: Institute of Neurosciences, UCLouvain
city: Bruxelles
country: Belgium
facility: Spontaneous contact via doctors or other partners
Study officials:
affiliation: Insititue of Neurosciences, UCLouvain
name: Yannick Bleyenheuft, Professor
role: PRINCIPAL_INVESTIGATOR
References: