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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
Belgium1 site, 1 recruiting
- Recruiting
Institute of Neuroscience, UCLouvain
Brussels, 1200
Yannick Bleyenheuft, Pr, +3227645446, yannick.bleyenheuft@uclouvain.be
Daniela Ebner, PhD, +3227645446, daniela.ebner@uclouvain.be
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 group | Role | What they receive |
|---|---|---|
| HABIT-ILE | Experimental | HABIT-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 care | Active comparator | Usual 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.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted11 Dec 2020
- Study start15 Dec 2020
- Primary completionNov 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Model description
- Allocation
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Mont-Godinne
- Responsible party
- Sponsor
- Investigators
- Yves Vandermeeren, MD,PhD, Principal investigator, Institute of Neuroscience, UCLouvain; CHU-UCL Namur, Neurology Department, UCLouvainYannick Bleyenheuft, PhD, Principal investigator, MSL-IN Lab, Institute of Neuroscience, UCLouvain
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 42966330Ebner-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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04664673
- Acronym / sponsor ID
- B403201316810h
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- University Hospital of Mont-Godinne
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 11 Dec 2020 (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, 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Allocation
| Arm | Type | Receives |
|---|---|---|
| HABIT-ILE | Experimental | Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) intervention during two weeks adapted for adults stroke survivors |
| Regular care | Active comparator | Behavioral: Regular careUsual customary treatment for adults stroke survivors during two weeks |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.)
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 |
|---|---|---|
| Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)Also: HABIT-ILE Strokemotor learning-based, intensive therapy originally developed for hemiplegic children. | Behavioural | HABIT-ILE |
| Regular careAlso: Usual carecustomary or usual treatment given to any adult stroke survivor | Behavioural | Regular care |
Primary outcome
Changes on the Adult Assisting Hand Assessment Stroke (Ad-AHA Stroke)
Time frame: baseline, 3 weeks and 13 weeks after baseline
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)
29 secondary outcomes
Changes on speed/accuracy trade-off during a bimanual reaching task (bi-SAT)
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes on force during a bimanual reaching task (bi-Force)
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes on bimanual coordination during a bimanual reaching task (bi-CO)
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes on bimanual smoothness during a bimanual reaching task (bi-smoothness)
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes on errors during a bimanual reaching task (bi-error)
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes in finger force tracking dexterity
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes in multifinger tapping dexterity
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes in cortical thickness of the brain's gray matter
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes in Fractional Anisotropy (FA) of the corticospinal tract from the motor cortex to the cerebellar peduncle
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes on the Axial, Radial and Mean Diffusivity (AD, RD, MD) of the corticospinal tract from the motor cortex to the cerebellar peduncle
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes on the metrics of the corticospinal tract from the motor cortex to the cerebellar peduncle using the NODDI model
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes on the metrics of the corticospinal tract from the motor cortex to the cerebellar peduncle using the DIAMOND model
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes in resting-state functional connectivity
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes in brain white matter microstructure (WM-μs) using the Microstructure Fingerprinting model
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes in upper extremities sensorimotor functions assess by the Fugl-Meyer Assessment (FMA-UE)
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes in upper extremities motor functions assess by the Wolf Motor Function Test (WMFT)
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes in unimanual dexterity assessed by the Box & Block test (BBT)
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes in the Six Minutes' Walk Test (6MWT)
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes in Canadian Occupational Performance Measure (COPM)
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes in the Stroke Impact Scale (SIS)
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes in activities of daily living assessed by ACTIVLIM-Stroke Questionnaire
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes in activities of daily living assessed by ABILHAND Questionnaire
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes in the modified Rankin Scale (mRS) for neurologic disability
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes in visual neglect assessed by the Bells Test
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes on the visuospatial short term working memory assessed by the "Corsi block-tapping test"
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes in the Montreal Cognitive Assessment (MoCA) test
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes in inhibitory control assessed by the Stroop Color and Word Test (SCWT)
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes in executive functions assessed by the Trail Making Test (TMT)
Time frame: baseline, 3 weeks and 13 weeks after baseline
Changes in the Wechsler Adult Intelligence Scale (WAIS-III)
Time frame: baseline, 3 weeks and 13 weeks after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Derived from this study: PubMed 42966330Gathy 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.
- Derived from this study: PubMed 37055214Ebner-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.
- 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. This study is not recruiting at the moment.
Yves Vandermeeren, MD,PhD principal investigator
Institute of Neuroscience, UCLouvain; CHU-UCL Namur, Neurology Department, UCLouvain
Yannick Bleyenheuft, PhD principal investigator
MSL-IN Lab, Institute of Neuroscience, UCLouvain
1 site in 1 country: see every site and its status.
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.