StrokeAd-NeuREHANCT06931795
Implementation of a HABIT-ILE Intervention at William Lennox Neurological Hospital (NeuREHA) - Adult
A study testing HABIT-ILE and Conventional intervention in people with Stroke, run by Université Catholique de Louvain at 3 sites in Belgium.
Trial summary
Using a randomized controlled trial design, in an hospital environment, possible changes induced by the "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" treatment program will be investigated in functional activities of daily living, motor and cognitive assessment of patients with… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Stroke
- What is being tested?
- HABIT-ILE and Conventional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesBelgium
- Study dates
- 15 Apr 2025to 24 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase aiguë ou subaiguë
Who cannot join
- Epilepsie instable
- Absence à déterminer sa volonté à participer
- Traitement toxine pendant le stage
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium3 sites
Institute of Neurosciences, UCLouvain
Brussels, 1200
Fanny Lacour, PT, fanny.lacour@vinci.be
Institute of Neurosciences, UCLouvain
Brussels
Spontaneous contact via doctors or other partners
Brussels
About this study
Official title: Implementation of a HABIT-ILE Intervention at the William Lennox Neurological Centre for Sub-acute Adult Post-stroke Patients (<6 Mois): a Randomised Controlled Trial
Using a randomized controlled trial design, in an hospital environment, possible changes induced by the "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" treatment program will be investigated in functional activities of daily living, motor and cognitive assessment of patients with sub-acute post-stroke
Read the detailed description
The aim is to investigate, for the first time, the effectiveness of HABIT-ILE therapy in a hospital setting in the treatment of a population representative of the clinical population for adult patients with subacute stroke.
The hypothesis is that an in-hospital HABIT-ILE protocol will be more effective than conventional therapies usually given to patients with sub-acute post-stroke, and that this difference will be objectively demonstrated by clinical assessments of motor function, cognition and participation conducted before and after treatment periods.
The aim of the study is therefore to evaluate the effect of intensive bimanual hand-arm therapy including the lower extremities (HABIT-ILE) on body functions and structures, activity and participation in adulte patients suffering from subacute stroke..
- Conditions
- Stroke
- Being tested
- HABIT-ILE, Conventional intervention
- Keywords
- stroke, intensive intervention, motor skill learning, subacute
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HABIT-ILEBehavioural
Also called HABIT-ILE Stroke
2 weeks HABIT-ILE
Conventional interventionBehavioural
2 weeks usual intervention (waitlist group)
| Study group | Role | What they receive |
|---|---|---|
| HABIT-ILE | Experimental | Hand and arm bimanual intensive therapy including lower extremities Receives: Behavioral: HABIT-ILE |
| Conventional Intervention | Active comparator | Conventional physical and occupational therapy (same amout of hours) Receives: Behavioral: Conventional intervention |
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: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Secondary outcomes (13)
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: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Changes in unimanual dexterity: Box and Blocks test (BBT)
The BBT is a test of gross manual dexterity. Each hand is tested individually and the BBT is scored through the number of blocks carried over the partition from one part to another part of a box during the one-minute trial period.
Measured: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Changes in Canadian Occupational Performance Measure (COPM)
This is an interview-setting designed to capture a patient's self-perception of performance and satisfaction of it in everyday activities, observed over time. During the interview, parents set up 5 activities considered difficult in daily life. These are then assessed, in a 1 to 10 scale, regarding the child's self-perception of performance and satisfaction of it. The total score is the average of the scores for perception and satisfaction separately (score from 1 to 10; higher score means better performance/satisfaction)
Measured: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
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: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
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: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
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: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
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: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
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: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Changes in balance control assessed by the mini Balance Evaluation System Test (mini BEST test)
The miniBEST test is a shortened version of the Balance Evaluation Systems Test (BESTest). It assesses 6 different balance control systems, the BESTest was shortened based on factor analysis to include dynamic balance only (Higher scores indicate better performance). The test is a 14-item test scord on a 3-level ordinal scale (0-2). higher score means better performance.
Measured: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Changes in the Two Minutes' Walk Test (2MWT)
The 2MWT assess endurance while walking 2 minutes without pause. More distance walked (in meters) indicate better performance.
Measured: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Changes in National Institutes of Health Stroke Scale (NIHSS)
The National Institutes of Health Stroke Scale (NIHSS) is a 15-item impairment assessment scale designed to evaluate the neurological consequences and degree of recovery of a stroke patient. The scale assesses level of consciousness, extraocular movements, field of vision, facial muscle function, strength of extremities, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria) and hemineglect (neglect).
Measured: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Changes in Tardieu Scale et Modified Tardieu Scale (MTS)
The Tardieu Scale and Modified Tardieu Scale (MTS) are clinical measures of muscle spasticity for use in patients with neurological disorders. In the Tardieu Scale or the MTS, spasticity is quantified by assessing the response of the muscle when it is stretched at various velocities.
Measured: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Changes in EQ-5D-5L
The system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion24 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yannick Bleyenheuft, Université Catholique de Louvain
- Investigators
- Yannick Bleyenheuft, PT, PhD, Professor, Principal investigator, Insititue of Neurosciences, UCLouvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931795
- Sponsor's protocol ID
- B0392023000045
- Acronym
- Ad-NeuREHA
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a HABIT-ILE Intervention at the William Lennox Neurological Centre for Sub-acute Adult Post-stroke Patients (<6 Mois): a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06931795
- Acronym / sponsor ID
- Ad-NeuREHA / B0392023000045
- Conditions
- Stroke
- Keywords
- stroke, intensive intervention, motor skill learning, subacute
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 24 Dec 2026 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using a randomized controlled trial design, in an hospital environment, possible changes induced by the "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" treatment program will be investigated in functional activities of daily living, motor and cognitive assessment of patients with sub-acute post-stroke
Detailed description
The aim is to investigate, for the first time, the effectiveness of HABIT-ILE therapy in a hospital setting in the treatment of a population representative of the clinical population for adult patients with subacute stroke.
The hypothesis is that an in-hospital HABIT-ILE protocol will be more effective than conventional therapies usually given to patients with sub-acute post-stroke, and that this difference will be objectively demonstrated by clinical assessments of motor function, cognition and participation conducted before and after treatment periods.
The aim of the study is therefore to evaluate the effect of intensive bimanual hand-arm therapy including the lower extremities (HABIT-ILE) on body functions and structures, activity and participation in adulte patients suffering from subacute stroke..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HABIT-ILE | Experimental | Behavioral: HABIT-ILEHand and arm bimanual intensive therapy including lower extremities |
| Conventional Intervention | Active comparator | Behavioral: Conventional interventionConventional physical and occupational therapy (same amout of hours) |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Phase aiguë ou subaiguë
Key exclusion criteria (3 listed)
- Epilepsie instable
- Absence à déterminer sa volonté à participer
- Traitement toxine pendant le stage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HABIT-ILEAlso: HABIT-ILE Stroke2 weeks HABIT-ILE | Behavioural | HABIT-ILE |
| Conventional intervention2 weeks usual intervention (waitlist group) | Behavioural | Conventional Intervention |
Primary outcome
Changes on the Adult Assisting Hand Assessment Stroke (Ad-AHA Stroke)
Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
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)
13 secondary outcomes
Changes in upper extremities sensorimotor functions assess by the Fugl-Meyer Assessment (FMA-UE)
Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Changes in unimanual dexterity: Box and Blocks test (BBT)
Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Changes in Canadian Occupational Performance Measure (COPM)
Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Changes in the Stroke Impact Scale (SIS)
Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Changes in activities of daily living assessed by ACTIVLIM-Stroke Questionnaire
Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Changes in activities of daily living assessed by ABILHAND Questionnaire
Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Changes in visual neglect assessed by the Bells Test
Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Changes in the Montreal Cognitive Assessment (MoCA) test
Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Changes in balance control assessed by the mini Balance Evaluation System Test (mini BEST test)
Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Changes in the Two Minutes' Walk Test (2MWT)
Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Changes in National Institutes of Health Stroke Scale (NIHSS)
Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Changes in Tardieu Scale et Modified Tardieu Scale (MTS)
Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Changes in EQ-5D-5L
Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yannick Bleyenheuft, PT, PhD, Professor principal investigator
Insititue of Neurosciences, UCLouvain
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HABIT-ILE and Conventional intervention in people with Stroke, run by Université Catholique de Louvain at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yannick Bleyenheuft, PT, PhD, Professor (32 2 764 93 49, yannick.bleyenheuft@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on the Adult Assisting Hand Assessment Stroke (Ad-AHA Stroke) (time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.