HABIT-ILE in Adults With Chronic Stroke (HABIT-ILE Stroke)
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)
Regular care
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.)
Sites / Locations
- Institute of Neuroscience, UCLouvainRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HABIT-ILE
Regular care
Arm Description
HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) intervention during two weeks adapted for adults stroke survivors
Usual customary treatment for adults stroke survivors during two weeks
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
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)
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
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)
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)
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.
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.
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.
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.
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.
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.
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.
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
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.
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)
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)
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)
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
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)
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)
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).
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).
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".
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.
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.
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)
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).
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).
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.
Full Information
NCT ID
NCT04664673
First Posted
December 2, 2020
Last Updated
June 16, 2022
Sponsor
Université Catholique de Louvain
Collaborators
University Hospital of Mont-Godinne
1. Study Identification
Unique Protocol Identification Number
NCT04664673
Brief Title
HABIT-ILE in Adults With Chronic Stroke (HABIT-ILE Stroke)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université Catholique de Louvain
Collaborators
University Hospital of Mont-Godinne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Allocation
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HABIT-ILE
Arm Type
Experimental
Arm Description
HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) intervention during two weeks adapted for adults stroke survivors
Arm Title
Regular care
Arm Type
Active Comparator
Arm Description
Usual customary treatment for adults stroke survivors during two weeks
Intervention Type
Behavioral
Intervention Name(s)
Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)
Other Intervention Name(s)
HABIT-ILE Stroke
Intervention Description
motor learning-based, intensive therapy originally developed for hemiplegic children.
Intervention Type
Behavioral
Intervention Name(s)
Regular care
Other Intervention Name(s)
Usual care
Intervention Description
customary or usual treatment given to any adult stroke survivor
Primary Outcome Measure Information:
Title
Changes on the Adult Assisting Hand Assessment Stroke (Ad-AHA Stroke)
Description
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)
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Secondary Outcome Measure Information:
Title
Changes on speed/accuracy trade-off during a bimanual reaching task (bi-SAT)
Description
By using the Rehabilitation Robot System (REAplan®), we calculate the bi-SAT through mathematical computation
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes on force during a bimanual reaching task (bi-Force)
Description
By using the REAplan® robot, we calculate the bimanual forces and forces exerted in the wrong direction by each arm (Newtons)
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes on bimanual coordination during a bimanual reaching task (bi-CO)
Description
By using the REAplan® robot, we calculate the phase coherence between speeds of both arms
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes on bimanual smoothness during a bimanual reaching task (bi-smoothness)
Description
By using the REAplan® robot, we calculate the Spectral Arc Length (SPARC) of the movement (unitless)
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes on errors during a bimanual reaching task (bi-error)
Description
By using the REAplan® robot, we calculate the amount of errors while performing the bimanual task (measured in centimeters or degrees)
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes in finger force tracking dexterity
Description
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.
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes in multifinger tapping dexterity
Description
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.
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes in cortical thickness of the brain's gray matter
Description
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.
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes in Fractional Anisotropy (FA) of the corticospinal tract from the motor cortex to the cerebellar peduncle
Description
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.
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes on the Axial, Radial and Mean Diffusivity (AD, RD, MD) of the corticospinal tract from the motor cortex to the cerebellar peduncle
Description
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.
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes on the metrics of the corticospinal tract from the motor cortex to the cerebellar peduncle using the NODDI model
Description
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.
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes on the metrics of the corticospinal tract from the motor cortex to the cerebellar peduncle using the DIAMOND model
Description
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.
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes in resting-state functional connectivity
Description
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
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes in brain white matter microstructure (WM-μs) using the Microstructure Fingerprinting model
Description
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.
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes in upper extremities sensorimotor functions assess by the Fugl-Meyer Assessment (FMA-UE)
Description
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)
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes in upper extremities motor functions assess by the Wolf Motor Function Test (WMFT)
Description
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)
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes in unimanual dexterity assessed by the Box & Block test (BBT)
Description
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)
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes in the Six Minutes' Walk Test (6MWT)
Description
The 6MWT assess endurance while walking 6 minutes without pause. More distance walked (in meters) indicate better performance
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes in Canadian Occupational Performance Measure (COPM)
Description
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)
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes in the Stroke Impact Scale (SIS)
Description
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)
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes in activities of daily living assessed by ACTIVLIM-Stroke Questionnaire
Description
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).
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes in activities of daily living assessed by ABILHAND Questionnaire
Description
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).
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes in the modified Rankin Scale (mRS) for neurologic disability
Description
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".
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes in visual neglect assessed by the Bells Test
Description
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.
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes on the visuospatial short term working memory assessed by the "Corsi block-tapping test"
Description
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.
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes in the Montreal Cognitive Assessment (MoCA) test
Description
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)
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes in inhibitory control assessed by the Stroop Color and Word Test (SCWT)
Description
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).
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes in executive functions assessed by the Trail Making Test (TMT)
Description
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).
Time Frame
baseline, 3 weeks and 13 weeks after baseline
Title
Changes in the Wechsler Adult Intelligence Scale (WAIS-III)
Description
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.
Time Frame
baseline, 3 weeks and 13 weeks after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yves Vandermeeren, PhD
Phone
+3281423321
Email
yves.vandermeeren@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Ebner, PhD
Phone
+3227645446
Email
daniela.ebner@uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves Vandermeeren, MD,PhD
Organizational Affiliation
Institute of Neuroscience, UCLouvain; CHU-UCL Namur, Neurology Department, UCLouvain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yannick Bleyenheuft, PhD
Organizational Affiliation
MSL-IN Lab, Institute of Neuroscience, UCLouvain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Neuroscience, UCLouvain
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yannick Bleyenheuft, Pr
Phone
+3227645446
Email
yannick.bleyenheuft@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Daniela Ebner, PhD
Phone
+3227645446
Email
daniela.ebner@uclouvain.be
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://uclouvain.be/en/research-institutes/ions/neur/neurology-department-chu-ucl-dinant-godinne.html
Description
University's department web page (english)
Learn more about this trial
HABIT-ILE in Adults With Chronic Stroke (HABIT-ILE Stroke)
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