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StrokeNCT04664673

HABIT-ILE in Adults With Chronic Stroke (HABIT-ILE Stroke)

A study testing Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and Regular care in people with Stroke, run by Université Catholique de Louvain at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Using a randomized controlled trial design, the possible changes induced by the intensive treatment program "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" will be studied in functional, everyday life activities and neuroplastic assessment of adults with chronic stroke. Read more about this study

Who is it for?
Ages 40 to 90 years
Conditions the study is for
Stroke
What is being tested?
Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and Regular care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteBelgium
Study dates
15 Dec 2020to Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

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 40 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • hemiparetic patient with a chronic stroke (over 6 months of evolution)
  • age 40 to 90 years old inclusive
  • ability to follow instructions and complete testing according to the age.

Who cannot join

  • alcohol/drug abuse
  • pregnancy
  • major cognitive impairment interfering with the study (severe aphasia, psychiatric conditions)
  • uncontrolled health issues (cardiac/renal failure)
  • contraindications to perform MRI assessments (Metal implants, etc.)

Trial locations and contacts

1 site in 1 country.

Yves Vandermeeren, PhD contact

+3281423321

yves.vandermeeren@uclouvain.be

Daniela Ebner, PhD contact

+3227645446

daniela.ebner@uclouvain.be

Belgium1 site, 1 recruiting
  • Institute of Neuroscience, UCLouvain

    Brussels, 1200

    Yannick Bleyenheuft, Pr, +3227645446, yannick.bleyenheuft@uclouvain.be

    Daniela Ebner, PhD, +3227645446, daniela.ebner@uclouvain.be

    Recruiting

Other trials in Belgium

About this study

Official title: Effect of the Intensive Intervention "Hand-Arm Bimanual Intensive Therapy Including Lower Extremities" (HABIT-ILE) in Chronic (> 6 Months) Adults With Acquired Brain Damage (Stroke)

Using a randomized controlled trial design, the possible changes induced by the intensive treatment program "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" will be studied in functional, everyday life activities and neuroplastic assessment of adults with chronic stroke.

Read the detailed description

Using a randomized controlled trial design, the possible changes in neuroimaging, motor function, motor learning and everyday life activities of adults with chronic stroke (> 6 months) after participating of the intensive treatment programme "Hand-arm Bimanual Intensive Therapy Including Lower Extremities" (HABIT-ILE) will be studied. Changes, scored by participants in case of questionnaires and by experts in the case of tests, will be observed comparing participants after their regular care/treatment and after receiving HABIT-ILE. Motor function, learning and daily life activities will be correlated with neuroplastic changes.

Conditions
Stroke
Being tested
Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE), Regular care
Medical subject headings
Stroke

What participants receive

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

  • Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)Behavioural

    Also called HABIT-ILE Stroke

    motor learning-based, intensive therapy originally developed for hemiplegic children.

  • Regular careBehavioural

    Also called Usual care

    customary or usual treatment given to any adult stroke survivor

Study groups in NCT04664673
Study groupRoleWhat they receive
HABIT-ILEExperimentalHABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) intervention during two weeks adapted for adults stroke survivors
Receives: Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)
Regular careActive comparatorUsual customary treatment for adults stroke survivors during two weeks
Receives: Behavioral: Regular care

What is being measured

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

  1. Changes on the Adult Assisting Hand Assessment Stroke (Ad-AHA Stroke)

    This assessment is an observation-based instrument assessing the effectiveness of the spontaneous use of the affected hand when performing bimanual activities in adults post stroke scored in a logit based 0-100 AHA-unit scale (higher score indicate higher ability)

    Measured: baseline, 3 weeks and 13 weeks after baseline

Secondary outcomes (29)
  1. Changes on speed/accuracy trade-off during a bimanual reaching task (bi-SAT)

    By using the Rehabilitation Robot System (REAplan®), we calculate the bi-SAT through mathematical computation

    Measured: baseline, 3 weeks and 13 weeks after baseline

  2. Changes on force during a bimanual reaching task (bi-Force)

    By using the REAplan® robot, we calculate the bimanual forces and forces exerted in the wrong direction by each arm (Newtons)

    Measured: baseline, 3 weeks and 13 weeks after baseline

  3. Changes on bimanual coordination during a bimanual reaching task (bi-CO)

    By using the REAplan® robot, we calculate the phase coherence between speeds of both arms

    Measured: baseline, 3 weeks and 13 weeks after baseline

  4. Changes on bimanual smoothness during a bimanual reaching task (bi-smoothness)

    By using the REAplan® robot, we calculate the Spectral Arc Length (SPARC) of the movement (unitless)

    Measured: baseline, 3 weeks and 13 weeks after baseline

  5. Changes on errors during a bimanual reaching task (bi-error)

    By using the REAplan® robot, we calculate the amount of errors while performing the bimanual task (measured in centimeters or degrees)

    Measured: baseline, 3 weeks and 13 weeks after baseline

  6. Changes in finger force tracking dexterity

    By using a finger force manipulandum (DEXTRAIN), which records the forces (in Newtons) applied by the fingers on pistons, we calculate the ability to control and release the force applied by the fingers during a tracking task.

    Measured: baseline, 3 weeks and 13 weeks after baseline

  7. Changes in multifinger tapping dexterity

    By using the DEXTRAIN, we assess the independent finger movements while simultaneous tapping with different finger configurations (two fingers or one finger) in response to visual instructions during a finger tapping task. The percentage of errors are considered.

    Measured: baseline, 3 weeks and 13 weeks after baseline

  8. Changes in cortical thickness of the brain's gray matter

    Regional brain cortical thickness is acquired from high resolution 3D T1-weighted structural imaging data. For each investigated region, mean cortical metrics (in millimeters) are assessed between the pial surface and the white/grey boundary.

    Measured: baseline, 3 weeks and 13 weeks after baseline

  9. Changes in Fractional Anisotropy (FA) of the corticospinal tract from the motor cortex to the cerebellar peduncle

    FA is a scalar value (no unit) between 0 and 1 that describes the degree of anisotropy of white matter water molecules. It is measured non-invasively via brain MRI using diffusion tensor imaging (DTI), a modality of Diffusion-Weighted Imaging (DWI). Increased values indicate a higher directionality of the tissue structure.

    Measured: baseline, 3 weeks and 13 weeks after baseline

  10. Changes on the Axial, Radial and Mean Diffusivity (AD, RD, MD) of the corticospinal tract from the motor cortex to the cerebellar peduncle

    AD, RD and MD are values ranging from 0 to 3.10-3 [mm2/s] that describe the degree of axial, radial and mean molecular diffusion of white matter water molecules. It is measured non-invasively via brain MRI using diffusion tensor imaging (DTI), a modality of Diffusion-Weighted Imaging (DWI). An increased MD can be considered to be an indicator of white matter damage.

    Measured: baseline, 3 weeks and 13 weeks after baseline

  11. Changes on the metrics of the corticospinal tract from the motor cortex to the cerebellar peduncle using the NODDI model

    The orientation dispersion index (ODI), intracellular volume fraction (ICVF) and the fraction of the isotropic compartment (ISOF) are scalar values ranging from 0 to 1 (no units) that describe the orientation of neural fibers, and the volume fraction of the intracellular and isotropic compartment. It is measured non-invasively via brain MRI using the Neurite Orientation Dispersion and Density Imaging (NODDI) model combined with a Diffusion-Weighted Imaging (DWI) sequence. The results reflects the overall coherence of the fibers, with zero representing highly coherent structures, hence less dispersion of the fibers.

    Measured: baseline, 3 weeks and 13 weeks after baseline

  12. Changes on the metrics of the corticospinal tract from the motor cortex to the cerebellar peduncle using the DIAMOND model

    By representing each voxel of the brain as the sum of multiple compartments (representing either a neural fiber population or an isotropic diffusion), the volume fraction and the heterogeneity of each compartment can be estimated. These metrics (ranging from 0 to 1, no unit) are measured non-invasively via brain MRI using the Distribution of 3D Anisotropic Microstructural environments in Diffusion-compartment imaging (DIAMOND) model combined with a Diffusion-Weighted Imaging (DWI) sequence. The results reflects the overall heterogeneity of the fibers, with zero representing more homogeny structures, hence less dispersion of the fibers.

    Measured: baseline, 3 weeks and 13 weeks after baseline

  13. Changes in resting-state functional connectivity

    Resting-state functional magnetic resonance imaging (rs-fMRI) evaluates the regional interactions that occur during the resting or task-negative state. The magnitude of the brain activation during rs-fMRI will be assessed

    Measured: baseline, 3 weeks and 13 weeks after baseline

  14. Changes in brain white matter microstructure (WM-μs) using the Microstructure Fingerprinting model

    Using a multiple-compartment approach, the signal obtained from a voxel can be estimated as the sum of multiple fiber populations, each presenting a specific fraction ('frac', ranging from 0 to 1, no unit), fiber volume fraction ('fvf', ranging from 0 to 1, no unit) and diffusivity ('diff', in [mm2/s]). On top of those fiber populations, isotropic compartments can also be represented with a specific fraction (frac) and diffusivity (diff). These metrics are measured non-invasively via brain MRI using the Microstructure Fingerprinting model combined with a Diffusion-Weighted Imaging (DWI) sequence.

    Measured: baseline, 3 weeks and 13 weeks after baseline

  15. Changes in upper extremities sensorimotor functions assess by the Fugl-Meyer Assessment (FMA-UE)

    The FMA-UE assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia. Maximum score is 66 points (Higher scores indicates better functioning levels)

    Measured: baseline, 3 weeks and 13 weeks after baseline

  16. Changes in upper extremities motor functions assess by the Wolf Motor Function Test (WMFT)

    The WMFT measures quantitative motor ability through 17 timed and functional tasks. Uses a 6-point ordinal scale (from 0= "does not attempt with the involved arm" to 5= "arm does participate; movement appears to be normal"). Maximum score is 75 (Higher scores indicates better functioning levels)

    Measured: baseline, 3 weeks and 13 weeks after baseline

  17. Changes in unimanual dexterity assessed by the Box & Block test (BBT)

    The BBT assess unimanual dexterity by quantifying the maximum of wooden blocks transferred from one space to the other during 1 minute (Higher scores indicate better performance)

    Measured: baseline, 3 weeks and 13 weeks after baseline

  18. Changes in the Six Minutes' Walk Test (6MWT)

    The 6MWT assess endurance while walking 6 minutes without pause. More distance walked (in meters) indicate better performance

    Measured: baseline, 3 weeks and 13 weeks after baseline

  19. Changes in Canadian Occupational Performance Measure (COPM)

    In this interview, patients set up 5 activities considered difficult in daily life. These are then assessed, in a 1 to 10 scale, regarding the patient'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)

    Measured: baseline, 3 weeks and 13 weeks after baseline

  20. Changes in the Stroke Impact Scale (SIS)

    Self-reported questionnaire assessing multidimensional repercussions of the Stroke (strength, hand function, daily life activities, mobility, communication, emotion, memory, thinking and participation). Domains are scored on a metric of 0 to 100 (higher scores indicate better self-reported health)

    Measured: baseline, 3 weeks and 13 weeks after baseline

  21. Changes in activities of daily living assessed by ACTIVLIM-Stroke Questionnaire

    The ACTIVLIM-Stroke questionnaire measures a patient's ability to perform daily activities requiring the use of the upper and/or lower extremities through 20 items specific to patients after stroke. It ranges from - 6 to +6 logits (higher score means better performance).

    Measured: baseline, 3 weeks and 13 weeks after baseline

  22. Changes in activities of daily living assessed by ABILHAND Questionnaire

    The ABILHAND questionnaire specific to patients with chronic stroke measures a patient's manual ability to manage daily activities that require the use of the upper extremities, whatever the strategies involved, through 23 items. It ranges from -6 to +6 logits (higher score means better performance).

    Measured: baseline, 3 weeks and 13 weeks after baseline

  23. Changes in the modified Rankin Scale (mRS) for neurologic disability

    mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The 6 levels of disability goes from 0 ("no disability/no symptoms") to 5 ("disability requiring constant care for all needs"), being 6 "death".

    Measured: baseline, 3 weeks and 13 weeks after baseline

  24. Changes in visual neglect assessed by the Bells Test

    The Bells Test is a cancellation test that allows for a quantitative and qualitative assessment of visual neglect in the near extra personal space. The patient score is based on the amount of time they take to complete the task, and the number of correct items (35 bells) they identify.

    Measured: baseline, 3 weeks and 13 weeks after baseline

  25. Changes on the visuospatial short term working memory assessed by the "Corsi block-tapping test"

    The test requires the patient to observe and then repeat in order a sequence of blocks "tapped". The task starts with a sequence of 2 blocks and gradually increases in length up to nine blocks. The test measures both the number of correct sequences and the longest sequence remembered. This number is known as the "Corsi Span", and averages about 5 for normal human subjects.

    Measured: baseline, 3 weeks and 13 weeks after baseline

  26. Changes in the Montreal Cognitive Assessment (MoCA) test

    The MoCA is a brief screening instrument originally designed to identify mild cognitive impairments in elderly patients attending a memory clinic. MoCA evaluates different domains (visuospatial abilities, executive functions, short-term memory recall, attention, concentration, working memory, language, and orientation to time and space) having a total of 30 points (higher scores indicate better self-reported health)

    Measured: baseline, 3 weeks and 13 weeks after baseline

  27. Changes in inhibitory control assessed by the Stroop Color and Word Test (SCWT)

    The SCWT is extensively used to assess the ability to inhibit cognitive interference occurring when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. The reaction time and the amount of errors are measured during incongruent and congruent tasks (lower reaction times and less errors indicates better performance).

    Measured: baseline, 3 weeks and 13 weeks after baseline

  28. Changes in executive functions assessed by the Trail Making Test (TMT)

    The TMT provides information on visual search, scanning, speed of processing, mental flexibility and executive functions using two subtasks, link numbers in increasing order and link letters and numbers in increasing order. The reaction time and the amount of errors are measured during the subtasks (lower reaction times and less errors indicates better performance).

    Measured: baseline, 3 weeks and 13 weeks after baseline

  29. Changes in the Wechsler Adult Intelligence Scale (WAIS-III)

    The WAIS-III provided scores for Verbal intelligence quotient (IQ), Performance IQ, and Full Scale IQ, along with four secondary indices (Verbal Comprehension, Working Memory, Perceptual Organization, and Processing Speed). The six Verbal Scale (Vocabulary, Similarities, Arithmetic, Digit Span, Information, and Comprehension) and five Performance Scale (Picture Completion, Digit Symbol (Coding), Block Design, Matrix Reasoning, and Picture Arrangement) subtests are combined to calculate the Full Scale IQ. After each subtest is scored, raw point totals are converted to scaled scores according to the examinee's age range (mean= 10; standard deviation=3). Sums of scaled scores then are computed separately for the six Verbal Scale subtests, five Performance Scale subtests, and all 11 subtests which constitute the Full Scale. The sums are converted to deviation IQs. The IQs generated have a mean of 100 and a standard deviation of 15 at all age levels.

    Measured: baseline, 3 weeks and 13 weeks after baseline

Timeline

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

  1. First posted11 Dec 2020
  2. Study start15 Dec 2020
  3. Primary completionNov 2022 (estimated)
  4. Study completionDec 2023 (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
Model description
Allocation
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04664673
Sponsor's protocol ID
B403201316810h
Status last verified
Jun 2022
First submitted
2 Dec 2020
Last updated
21 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gathy E, Ebner-Karestinos D, Carton de Tournai A, Herman E, Araneda R, Rosselli Z, Somville M, Dricot L, Macq B, Vandermeeren Y, Bleyenheuft Y. Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in adults with chronic stroke: a randomized controlled trial. Ann Phys Rehabil Med. 2026 Oct 31;69(8):102189. doi: 10.1016/j.rehab.2026.102189. Online ahead of print.

    PubMed 42966330
  • Ebner-Karestinos D, Gathy E, Carton de Tournai A, Herman E, Araneda R, Dricot L, Macq B, Vandermeeren Y, Bleyenheuft Y. Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in adults with chronic stroke: protocol of a randomised controlled trial. BMJ Open. 2023 Apr 13;13(4):e070642. doi: 10.1136/bmjopen-2022-070642.

    PubMed 37055214

Questions about this trial

What is this clinical trial studying?

A study testing Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and Regular care in people with Stroke, run by Université Catholique de Louvain at 1 site 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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

Contact Yves Vandermeeren, PhD (+3281423321, yves.vandermeeren@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes on the Adult Assisting Hand Assessment Stroke (Ad-AHA Stroke) (time frame: baseline, 3 weeks and 13 weeks after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04664673, which also lists 2 linked publications.

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 21 Jun 2022.

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