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Recruiting NCT05900778

Implementation of a HABIT-ILE Intervention at William Lennox Neurological Hospital (NeuREHA)

No phase Interventional Acquired Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HABIT-ILE, Conventional intervention.
Who it may be relevant to
Registry conditions: Acquired Brain Injury. Basic parameters: 5 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Implementation of a HABIT-ILE Intervention at William Lennox Neurological : a Randomized Controlled Trial

Overview

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.

Interventions

  • Behavioral HABIT-ILE
    2 weeks HABIT-ILE
  • Behavioral Conventional intervention
    2 weeks usual intervention (waitlist group)

Primary outcome measures

  • Flanker task [Time frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
  • Changes in Gross Motor Function Measurement (GMFM 66) [Time frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Secondary outcome measures (12)
  • Changes in isometric muscular strength (Jamar) [Time frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
  • Stroop task [Time frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
  • Changes in unimanual dexterity: Box and Blocks test (BBT) [Time frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
  • Changes on bimanual function (Assisting Hand Assessment (AHA)) [Time frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
  • Changes in 6 Minutes Walking Test (6MWT) [Time frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
  • Changes in Pediatric balance scale (PBS) [Time frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
  • Changes in Canadian Occupational Performance Measure (COPM) [Time frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
  • Changes in ACTIVLIM-CP questionnaire [Time frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
  • Changes in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) [Time frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
  • Changes in Pediatric quality of life inventory (PedsQL) [Time frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
  • Changes in Measure of Processes of Care (MPOC-20) [Time frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
  • Status in Wechsler Intelligence Scale for Children-Non verbal short version (WISC) [Time frame: T0 (baseline)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Belgium · 3 centers
  • Centre Hospitalier Neurologique William Lennox — Ottignies-Louvain-la-Neuve
  • Institute of Neurosciences, UCLouvain — Brussels
  • Spontaneous contact via doctors or other partners — Brussels

Identifiers

NCT: NCT05900778 · B0392023000044

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗