HABIT-ILE in Adults With Chronic Stroke (HABIT-ILE Stroke)
NCT04664673, Not applicable, Unknown, Université Catholique de Louvain
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | HABIT-ILE in Adults With Chronic Stroke (HABIT-ILE Stroke) | ClinicalTrials.gov |
| NCT number | NCT04664673 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 48 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Université Catholique de Louvain | ClinicalTrials.gov |
| Conditions | Stroke | ClinicalTrials.gov |
| Interventions | Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE), Regular care | ClinicalTrials.gov |
| First posted | 2020-12-11 | ClinicalTrials.gov |
| Last updated | 2022-06-21 | ClinicalTrials.gov |
Registered outcomes 30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Changes on the Adult Assisting Hand Assessment Stroke (Ad-AHA Stroke) | 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) | ClinicalTrials.gov |
| Secondary | Changes on speed/accuracy trade-off during a bimanual reaching task (bi-SAT) | baseline, 3 weeks and 13 weeks after baseline | By using the Rehabilitation Robot System (REAplan®), we calculate the bi-SAT through mathematical computation | ClinicalTrials.gov |
| Secondary | Changes on force during a bimanual reaching task (bi-Force) | baseline, 3 weeks and 13 weeks after baseline | By using the REAplan® robot, we calculate the bimanual forces and forces exerted in the wrong direction by each arm (Newtons) | ClinicalTrials.gov |
| Secondary | Changes on bimanual coordination during a bimanual reaching task (bi-CO) | baseline, 3 weeks and 13 weeks after baseline | By using the REAplan® robot, we calculate the phase coherence between speeds of both arms | ClinicalTrials.gov |
| Secondary | Changes on bimanual smoothness during a bimanual reaching task (bi-smoothness) | baseline, 3 weeks and 13 weeks after baseline | By using the REAplan® robot, we calculate the Spectral Arc Length (SPARC) of the movement (unitless) | ClinicalTrials.gov |
| Secondary | Changes on errors during a bimanual reaching task (bi-error) | baseline, 3 weeks and 13 weeks after baseline | By using the REAplan® robot, we calculate the amount of errors while performing the bimanual task (measured in centimeters or degrees) | ClinicalTrials.gov |
| Secondary | Changes in finger force tracking dexterity | baseline, 3 weeks and 13 weeks after baseline | 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. | ClinicalTrials.gov |
| Secondary | Changes in multifinger tapping dexterity | baseline, 3 weeks and 13 weeks after baseline | 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. | ClinicalTrials.gov |
| Secondary | Changes in cortical thickness of the brain's gray matter | baseline, 3 weeks and 13 weeks after baseline | 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. | ClinicalTrials.gov |
| Secondary | Changes in Fractional Anisotropy (FA) of the corticospinal tract from the motor cortex to the cerebellar peduncle | baseline, 3 weeks and 13 weeks after baseline | 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. | ClinicalTrials.gov |
| Secondary | Changes on the Axial, Radial and Mean Diffusivity (AD, RD, MD) of the corticospinal tract from the motor cortex to the cerebellar peduncle | baseline, 3 weeks and 13 weeks after baseline | 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. | ClinicalTrials.gov |
| Secondary | Changes on the metrics of the corticospinal tract from the motor cortex to the cerebellar peduncle using the NODDI model | baseline, 3 weeks and 13 weeks after baseline | 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. | ClinicalTrials.gov |
| Secondary | Changes on the metrics of the corticospinal tract from the motor cortex to the cerebellar peduncle using the DIAMOND model | baseline, 3 weeks and 13 weeks after baseline | 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. | ClinicalTrials.gov |
| Secondary | Changes in resting-state functional connectivity | baseline, 3 weeks and 13 weeks after baseline | 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 | ClinicalTrials.gov |
| Secondary | Changes in brain white matter microstructure (WM-μs) using the Microstructure Fingerprinting model | baseline, 3 weeks and 13 weeks after baseline | 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. | ClinicalTrials.gov |
| Secondary | Changes in upper extremities sensorimotor functions assess by the Fugl-Meyer Assessment (FMA-UE) | baseline, 3 weeks and 13 weeks after baseline | 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) | ClinicalTrials.gov |
| Secondary | Changes in upper extremities motor functions assess by the Wolf Motor Function Test (WMFT) | baseline, 3 weeks and 13 weeks after baseline | 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) | ClinicalTrials.gov |
| Secondary | Changes in unimanual dexterity assessed by the Box & Block test (BBT) | baseline, 3 weeks and 13 weeks after baseline | 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) | ClinicalTrials.gov |
| Secondary | Changes in the Six Minutes' Walk Test (6MWT) | baseline, 3 weeks and 13 weeks after baseline | The 6MWT assess endurance while walking 6 minutes without pause. More distance walked (in meters) indicate better performance | ClinicalTrials.gov |
| Secondary | Changes in Canadian Occupational Performance Measure (COPM) | baseline, 3 weeks and 13 weeks after baseline | 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) | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 8
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Cancellation Test | Secondary outcome | ConductCognition |
| Corsi Block-Tapping Test | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Finger Tapping Task | Secondary outcome | ConductCognition |
| Matrix Reasoning | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)