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

Université Catholique de Louvain

Status: Enrolling

Conditions: Acquired Brain Injury

Treatments: Behavioral: HABIT-ILE; Behavioral: Conventional intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05900778

B0392023000044

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

HABIT-ILE

Experimental group

Description:

Hand and arm bimanuel intensive therapy including lowers extremities

Treatment:

Behavioral: HABIT-ILE

Conventional intervention

Active Comparator group

Description:

Conventional physical and occupational therapy

Treatment:

Behavioral: Conventional intervention