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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-18
SponsorUniversité Catholique de Louvain

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

children with acquired brain injury of school

age 5 to 18 years inclusive

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • HABIT-ILE

    Behavioral

    2 weeks HABIT-ILE

  • Conventional intervention

    Behavioral

    2 weeks usual intervention (waitlist group)

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: HABIT-ILEExperimental treatment 1 intervention
Group B: Conventional interventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Flanker task

Cognitive functions of the children will be assessed by Flanker task.

Time frame
T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
2

Changes in Gross Motor Function Measurement (GMFM 66)

The GMFM has been developed to measure the change in gross motor function over time in children with cerebral palsy.

Time frame
T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)

Secondary outcomes

1

Changes in isometric muscular strength (Jamar)

A quantitative and objective measure of isometric muscular strength of hand and forearm.

Time frame
T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
2

Stroop task

Executive functions of the children will be assessed by Stroop task.

Time frame
T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
3

Changes in unimanual dexterity: Box and Blocks test (BBT)

The BBT is a test of gross manual dexterity. Each hand is tested individually and the BBT is scored through the number of blocks carried over the partition from one part to another part of a box during the one-minute trial period.

Time frame
T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
4

Changes on bimanual function (Assisting Hand Assessment (AHA))

Developed to observe the efficacy of the assisting hand use, in children with unilateral cerebral palsy (scored in percentage), during bimanual activities for the randomized controlled trial

Time frame
T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)

Other outcomes

Sponsors and contacts

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