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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
Belgium3 sites, 3 recruiting
- 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
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.
- Conditions
- 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 group | Role | What they receive |
|---|---|---|
| HABIT-ILE | Experimental | Hand and arm bimanuel intensive therapy including lowers extremities Receives: Behavioral: HABIT-ILE |
| Conventional intervention | Active comparator | Conventional 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.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
- First posted13 Jun 2023
- Study start10 Jun 2023
- Primary completion20 Dec 2024 (estimated)
- Study completion10 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yannick Bleyenheuft, Université Catholique de Louvain
- Investigators
- Yannick Bleyenheuft, Professor, Principal investigator, Insititue of Neurosciences, UCLouvain
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a HABIT-ILE Intervention at William Lennox Neurological : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05900778
- Acronym / sponsor ID
- NeuREHA / B0392023000044
- Conditions
- Acquired Brain Injury
- Keywords
- motor skill learning, executive function, activity of daily living, intensive therapy, acquired brain injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 10 Jun 2028 (estimated)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HABIT-ILE | Experimental | Behavioral: HABIT-ILEHand and arm bimanuel intensive therapy including lowers extremities |
| Conventional intervention | Active comparator | Behavioral: Conventional interventionConventional physical and occupational therapy |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- children with acquired brain injury of school
- age 5 to 18 years inclusive
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HABIT-ILE2 weeks HABIT-ILE | Behavioural | HABIT-ILE |
| Conventional intervention2 weeks usual intervention (waitlist group) | Behavioural | Conventional intervention |
Primary outcome
Flanker task
Time frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Cognitive functions of the children will be assessed by Flanker task.
Changes in Gross Motor Function Measurement (GMFM 66)
Time frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
The GMFM has been developed to measure the change in gross motor function over time in children with cerebral palsy.
14 secondary outcomes
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)
Classification du niveau moteur: The Gross Motor Function Classification System - Expanded & Revised (GMFCS - E&R)
Time frame: T0 (baseline)
QUALITY OF LIFE : KIDSCREEN 10
Time frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yannick Bleyenheuft, Professor principal investigator
Insititue of Neurosciences, UCLouvain
3 sites in 1 country: see every site and its status.
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.