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Acquired Brain InjuryNeuREHANCT05900778

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

A study testing HABIT-ILE and Conventional intervention in people with Acquired Brain Injury, run by Université Catholique de Louvain at 3 sites in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 5 to 18 years
Conditions the study is for
Acquired Brain Injury
What is being tested?
HABIT-ILE and Conventional intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesBelgium
Study dates
10 Jun 2023to 10 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yannick Bleyenheuft, Professor contact

+32 2 764 93 49

yannick.bleyenheuft@uclouvain.be

Julie Paradis, Doctor contact

+32 489 28 12 50

julie.paradis@vinci.be

Belgium3 sites, 3 recruiting
  • Institute of Neurosciences, UCLouvain

    Brussels, 1200

    Yannick Bleyenheuft, Professor, +32 2 764 93 49, yannick.bleyenheuft@uclouvain.be

    Julie Paradis, +32 489 28 12 50, julie.paradis@vinci.be

    Recruiting
  • Spontaneous contact via doctors or other partners

    Brussels

    anne Klocker, PhD, anne.klocker@vinci.be

    Recruiting
  • Centre Hospitalier Neurologique William Lennox

    Ottignies-Louvain-la-Neuve, Brabant-Wallon, 1340

    Anne Klocker, PhD, anne.klocker@vinci.be

    Recruiting

Other trials in Belgium

About this study

Official title: Implementation of a HABIT-ILE Intervention at William Lennox Neurological : a Randomized Controlled 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.

Read the 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.

Being tested
HABIT-ILE, Conventional intervention
Keywords
motor skill learning, executive function, activity of daily living, intensive therapy, acquired brain injury
Medical subject headings
Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HABIT-ILEBehavioural

    2 weeks HABIT-ILE

  • Conventional interventionBehavioural

    2 weeks usual intervention (waitlist group)

Study groups in NCT05900778
Study groupRoleWhat they receive
HABIT-ILEExperimentalHand and arm bimanuel intensive therapy including lowers extremities
Receives: Behavioral: HABIT-ILE
Conventional interventionActive comparatorConventional physical and occupational therapy
Receives: Behavioral: Conventional intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Flanker task

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

    Measured: 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.

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

Secondary outcomes (14)
  1. Changes in isometric muscular strength (Jamar)

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

    Measured: 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.

    Measured: 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.

    Measured: 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

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

  5. Changes in 6 Minutes Walking Test (6MWT)

    The 6 Minutes Walking Test measures the distance that the patient walk as much as possible within a period of 6-minutes in a 30 meters long corridor.

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

  6. Changes in Pediatric balance scale (PBS)

    A 14-item criterion-referencekd measure that examines functional balance in the context of everyday tasks in the pediatric population.

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

  7. Changes in Canadian Occupational Performance Measure (COPM)

    This is an interview-setting designed to capture a patient's self-perception of performance and satisfaction of it in everyday activities, observed over time. During the interview, parents set up 5 activities considered difficult in daily life. These are then assessed, in a 1 to 10 scale, regarding the child's self-perception of performance and satisfaction of it. The total score is the average of the scores for perception and satisfaction separately (score from 1 to 10; higher score means better performance/satisfaction)

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

  8. Changes in ACTIVLIM-CP questionnaire

    This parent's filled questionnaire measures a patient's ability to perform daily activities requiring the use of the upper and/or the lower extremities through 43 items specific to patients with cerebral palsy. It ranges from - 7 to +7 logits (higher score means better performance).

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

  9. Changes in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)

    The PEDI-CAT is the new version of the Pediatric Evaluation of Disability Inventory (PEDI). The PEDI-CAT is comprised of 276 functional activities acquired throughout infancy, childhood and young adulthood. Based on the nternational Classification of Functioning, Disability and Health for Children and Youth (ICF-CY) model, the PEDI-CAT contents provide information about the activities and participation component. It ranges from 0 to 100% (higher score means better performance).

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

  10. Changes in Pediatric quality of life inventory (PedsQL)

    The Pediatric Quality of Life Inventory is a brief measure of health-related quality of life in children and young people. The measure can be completed by parents (the Proxy Report) as well as children and young people (the Self-Report).

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

  11. Changes in Measure of Processes of Care (MPOC-20)

    Assesses the parents' perceptions of the care they and their children receive from children's rehabilitation treatment centres. Using a 8-point response scale, parents answer to 20 questions, indicating to what extent they have experienced the events or the situations described. A score of 7 means that they have experienced this aspect to a very great extent, or most of the time. A score of 1 means that they have not experienced this aspect at all. A score of 0 means that the question does not apply to them.

    There is no total score. However, because the statements are positively worded, higher total scores indicates that needs of the parents are being met to a great extent.

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

  12. Status in Wechsler Intelligence Scale for Children-Non verbal short version (WISC)

    This is a validated assessment for children aged 4 and over, with subtests such as object assembly, recognition, picture arrangement and fluid reasoning. The brief 15-20 minute version will be used. Scores are given for the full battery and for the subtests (subtest T-scores and percentile ranks).

    Measured: T0 (baseline)

  13. Classification du niveau moteur: The Gross Motor Function Classification System - Expanded & Revised (GMFCS - E&R)

    The Gross Motor Function Classification System - Expanded \& Revised (GMFCS - E\&R) is a 5-level classification system that describes the gross motor function of children and youth on the basis of their self-initiated movement with particular emphasis on sitting, walking, and wheeled mobility.

    Measured: T0 (baseline)

  14. QUALITY OF LIFE : KIDSCREEN 10

    The Gross Motor Function Classification System - Expanded \& Revised (GMFCS - E\&R)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2023
  2. Study start10 Jun 2023
  3. Primary completion20 Dec 2024 (estimated)
  4. Study completion10 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05900778
Sponsor's protocol ID
B0392023000044
Acronym
NeuREHA
Status last verified
Jun 2023
First submitted
2 Jun 2023
Last updated
18 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing HABIT-ILE and Conventional intervention in people with Acquired Brain Injury, run by Université Catholique de Louvain at 3 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yannick Bleyenheuft, Professor (+32 2 764 93 49, yannick.bleyenheuft@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Flanker task (time frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.

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