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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-10

Study Completion Date

2028-06-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acquired Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HABIT-ILE

Hand and arm bimanuel intensive therapy including lowers extremities

Group Type EXPERIMENTAL

HABIT-ILE

Intervention Type BEHAVIORAL

2 weeks HABIT-ILE

Conventional intervention

Conventional physical and occupational therapy

Group Type ACTIVE_COMPARATOR

Conventional intervention

Intervention Type BEHAVIORAL

2 weeks usual intervention (waitlist group)

Interventions

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HABIT-ILE

2 weeks HABIT-ILE

Intervention Type BEHAVIORAL

Conventional intervention

2 weeks usual intervention (waitlist group)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No