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StrokeHABITILEhomeNCT05727111

Implementation of a HABIT-ILE Intervention at Home for Chronic Stroke

A study testing Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) implemented at the patient home, Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and Follow-up Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) at the patient's home in people with Stroke, run by Université Catholique de Louvain at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will use a randomized controlled trial design to assess the possible difference between two intensive treatment programs: a classic "Hand and Arm Bimanual Intensive Therapy Including Lower Extremities" (HABIT-ILE) therapy and a HABIT-ILE therapy implemented at the patient's home. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Stroke
What is being tested?
Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) implemented at the patient home, Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and Follow-up Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) at the patient's home
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteBelgium
Study dates
1 May 2023to 31 Dec 2027
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 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults with a chronic stroke (older than 6 months)
  • Ability to interact and understand simple instructions in order to complete assessments and therapy
  • Ability to perform a partial shoulder flexion or abduction, a partial elbow extension, and hold an object in the paretic hand
  • Availability of a caregiver for 6h30 per day during two weeks of therapy

Who cannot join

  • Non controlled seizure
  • Botulinum toxin injection in the last 6 months before the first assessment or during the therapy
  • Intensive therapy in the last 6 months before the first assessment or during the therapy
  • Surgery that could affect the assessments or therapy in the last 6 months before the first assessment or during the therapy
  • Severe visual or cognitive impairments interfering with treatment and or assessments

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yannick Bleyenheuft, Phd, Prof. contact

+32 486 91 99 11

yannick.bleyenheuft@uclouvain.be

Merlin Somville, Phd student contact

+32 477 08 26 77

merlin.somville@uclouvain.be

Belgium1 site, 1 recruiting
  • MSL-IN lab, IoNS, UCLouvain

    Brussels, 1200

    Yannick Bleyenheuft, Phd, Prof., +32 2 764 54 46, yannick.bleyenheuft@uclouvain.be

    Merlin Somville, PT, +32477082677, merlin.somville@uclouvain.be

    Recruiting

Other trials in Belgium

About this study

Official title: Implementation of a HABIT-ILE Intervention at Home for Individuals With Chronic Stroke: a Non-inferiority Randomized Controlled Trial

This study will use a randomized controlled trial design to assess the possible difference between two intensive treatment programs: a classic "Hand and Arm Bimanual Intensive Therapy Including Lower Extremities" (HABIT-ILE) therapy and a HABIT-ILE therapy implemented at the patient's home. Moreover, this study also aims to assess whether the patient's abilities are better with follow-up than without follow-up after two weeks of HABIT-ILE therapy. The possible difference between the therapies will be studied in terms of functional capacities, activities and social participation.

Read the detailed description

Strokes are one of the leading causes of disability in adults around the world, with a 24.9% risk of stroke for an adult over their lifetime. The main health problems caused by brain injury result in different symptoms from one patient to another. The consequences of these symptoms are highly variable and result in long-term functional deficits in activities of daily living, such as dressing, eating, going to the toilet, etc. To improve the autonomy of these patients, intensive therapies based on the principles of motor learning have proved to be particularly effective. Among these therapies, HABIT-ILE ("Hand-Arm Bimanual Intensive Therapy including Lower Extremities") has been developed over the past decade in the MSL-IN laboratory at UCLouvain and has shown impressive improvements in children with PC. For stroke, other intensive therapies based on the same principles, such as Constraint Induced Movement Therapy (CIMT), have proven to be more effective than usual care. As HABIT-ILE shares the same principles with CIMT and differs by being more functional by the use of both hands, lower extremities and trunk simultaneously, we can assume that HABIT-ILE should also be effective with stroke patients. In addition, preliminary data from other studies on the efficacy of HABIT-ILE in stroke patients are promising. HABIT-ILE is based on intensive training of bimanual activities, with the systematic inclusion of stimulation of motor control of the lower limbs and trunk. HABIT-ILE is based on intensive training of bimanual activities, with the systematic inclusion of stimulation of motor control of the lower limbs and trunk. This therapy takes the form of a rehabilitation camp of at least 50 hours, on site. Therefore, the implementation of a classic HABIT-ILE camp requires a great commitment from families who must go to the camp for two weeks of therapy. For patients living far from big cities or unable to travel, access to these therapies can be very complex. In addition, these camps are run in groups of 8 to 12 participants. Each participant is accompanied by at least one therapist (physiotherapist or occupational therapist) trained in HABIT-ILE therapy. This implies that a HABIT-ILE camp requires at least 12 trained therapists. Moreover, there is a lack of therapists which makes the implementation of these camps still difficult. In addition, COVID-19 health requirements make it difficult to implement any type of treatment and assess patient progress. This health crisis has highlighted the importance of being able to offer telerehabilitation sessions at home, with a remote health professional to supervise the therapy. To address the problem of accessibility and the lack of HABIT-ILE therapists, the idea of implementing HABIT-ILE at home was born. How could we apply the principles of motor learning at home? Some of the key elements of motor learning are intensity, shaping of the task (starting from a partial task and increasing difficulty), goal-oriented therapy, positive reinforcement and hands-off (voluntary movements by patients, not guided by the therapist). In addition, virtual reality is well adapted to help integrate these principles and allows remote communication with patients. However, these devices alone do not allow the implementation of all the principles of motor learning but with the supervision of therapists trained in HABIT-ILE supervision, this goal could be achieved. The purpose of this randomized controlled study is to assess whether HABIT-ILE at home is not inferior to conventional (camp) HABIT-ILE in terms of physical abilities, functional activities and social participation of participants. Both modalities will be carried out during two weeks with a pace of 6,5 hours per day for a total of 10 days.

In addition, while the maintenance of skills during the HABIT-ILE camp at 3- and 6-months post-therapy has been proven, the issue of post-therapy improvement has not yet been studied. Indeed, we know that to maintain the skills acquired during the HABIT-ILE therapy, it is necessary to practice them daily. If a skill is not used, it will result in a cortical reorganization of the motor cortex to the detriment of that skill. Thus, there is a persistent cycle of decrease in use that leads to an unfavorable cortical reorganization that leads to a decrease in use, etc. This phenomenon is called "learned non-use". In order to reduce this phenomenon and thus improve the transfer of HABIT-ILE skills in the daily life of patients, we wonder about the benefits of post-therapy follow-up. Once again, the implementation of a HABIT-ILE protocol at home can provide us with a delocalized daily therapy solution implemented directly in the patient and supervised remotely. After the two weeks of the HABIT-ILE modality, we will set up a HABIT-ILE telerehabilitation follow-up for 9 weeks. This follow-up will be carried out over 9 weeks with a pace of 1 hour per day (except during the weekend, 5 hours/week). This study also aims to assess whether the patient's abilities are better with follow-up than without follow-up after two weeks of HABIT-ILE therapy.

Conditions
Stroke
Being tested
Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) implemented at the patient home, Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE), Follow-up Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) at the patient's home, Usual care
Keywords
HABIT-ILE, Intensive therapy based on motor skill learning, Home rehabilitation, Caregiver, Chronic Stroke, Telerehabilitation
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) implemented at the patient homeBehavioural

    Also called HABIT-ILE@home

    The HABIT-ILE therapy at home will follow the same principles as the classic HABIT-ILE. The therapy will take place in the patient's home and a close person (caregiver) will accompany the patient during the therapy. A device will be used to facilitate the implementation of home therapy. Supervision of the therapeutic process will be done remotely by a team of trained supervisors. One hour of remote supervision per day will be scheduled within 6.5 hours of therapy.

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

    Also called Classic HABIT-ILE

    HABIT-ILE ("Hand-Arm Bimanual Intensive Therapy including Lower Extremities") is an intensive therapy that continuously incorporates postural control and LE function. This motor learning-based approach include specificity of the practice, motivation, shaping of the task, intensive blocks of training and Hands-Off. Moreover, the therapy is goal-oriented to increase functional independence during daily living.

  • Follow-up Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) at the patient's homeBehavioural

    Also called Follow-up HABIT-ILE@home

    HABIT-ILE follow-up at home follow the same principles as classic HABIT-ILE but is delivered at the patient home with 1 hour per day (4 hours per week in autonomy and 1 hour per week under supervision).

  • Usual careBehavioural

    Also called Customary care

    Usual care is all the weekly physiotherapy and occupational therapy sessions that the patient usually receives.

Study groups in NCT05727111
Study groupRoleWhat they receive
HABIT-ILE therapy at home with a HABIT-ILE follow-up at homeExperimental2 weeks of HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) therapy at home followed by 9 weeks of HABIT-ILE follow-up at home
Receives: Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) implemented at the patient home; Behavioral: Follow-up Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) at the patient's home
HABIT-ILE therapy at home followed by usual careExperimental2 weeks of HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) therapy at home followed by 9 weeks of usual care
Receives: Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) implemented at the patient home; Behavioral: Usual care
Classic HABIT-ILE therapy followed by usual careActive comparator2 weeks of classic HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) therapy on site followed by 9 weeks of usual care
Receives: Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE); Behavioral: Usual care
Classic HABIT-ILE therapy with HABIT-ILE follow-up at homeActive comparator2 weeks of classic HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) therapy on site followed by 9 weeks of HABIT-ILE follow-up at home
Receives: Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE); Behavioral: Follow-up Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) at the patient's home

What is being measured

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

  1. Changes in upper and lower extremities sensorimotor functions assess by the Fugl-Meyer Assessment (FMA).

    The FMA assess reflex activity, movement control and muscle strength in the upper and lower extremities of people with post-stroke hemiplegia. Maximum score is 100 points for motor score (Higher scores indicates better functioning levels).

    Measured: Baseline, 2 weeks and 12 weeks after baseline

Secondary outcomes (13)
  1. 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, 2 weeks and 12 weeks after baseline

  2. 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: Baseline, 2 weeks and 12 weeks after baseline

  3. 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, 2 weeks and 12 weeks after baseline

  4. 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, 2 weeks and 12 weeks after baseline

  5. Changes in lower limbs physical activity

    With a movement sensor on each wrist and on the affected leg, the percentage of total time spent in movement (Standing, walking or sitting) is measured. Calculated in terms of the changes in the acceleration (m/s²).

    Measured: During the 2 weeks of therapy

  6. Changes in upper limbs physical activity

    With a movement sensor on each wrist and on the affected leg, the activities of both hand is quantified. Calculated in terms of the changes in the acceleration (m/s²).

    Measured: During the 2 weeks of therapy

  7. 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, 2 weeks and 12 weeks after baseline

  8. 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, 2 weeks and 12 weeks after baseline

  9. 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, 2 weeks and 12 weeks after baseline

  10. 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, 2 weeks and 12 weeks after baseline

  11. 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, 2 weeks and 12 weeks after baseline

  12. Changes in the SATIS-STROKE scale

    The SATIS-Stroke questionnaire is administered on an interview basis or preferentially self-administrated (patients do not realize the life situation). Patients are asked to estimate the satisfaction or dissatisfaction level in performing each life situation. During the evaluation, a 4-level response scale is presented to the patients. Patients are asked to rate their perception on the response scale as either "Very dissatisfied", "Dissatisfied", "Satisfied" or "Very satisfied". Life situations not attempted in the last month are not scored and are entered as missing responses.

    Measured: Baseline, 2 weeks and 12 weeks after baseline

  13. Changes in the PILS-STROKE scale

    The PILS-Stroke questionnaire self-administrated (patients do not realize the life situation). Patients are asked to estimate the participation or non-participation level in performing each life situation. During the evaluation, a 3-level response scale is presented to the patients. Patients are asked to rate their participation on the response scale as either "I do not participate", "I participate a little", "I participate a lot". Life situations that the patient do not want to participate in are rated with "?".

    Measured: Baseline, 2 weeks and 12 weeks after baseline

Timeline

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

  1. First posted14 Feb 2023
  2. Study start1 May 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The trial will be a single-blind, randomized, monocentric controlled trial. The trial start with a division in two arms HABIT-ILE therapy classic or at home then half of each group will benefit from a HABIT-ILE follow-up while the other will have usual care. That means that participants will be divided into four groups.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05727111
Sponsor's protocol ID
B4032022000142b
Acronym
HABITILEhome
Status last verified
May 2023
First submitted
2 Feb 2023
Last updated
9 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wolf SL, Winstein CJ, Miller JP, Taub E, Uswatte G, Morris D, Giuliani C, Light KE, Nichols-Larsen D; EXCITE Investigators. Effect of constraint-induced movement therapy on upper extremity function 3 to 9 months after stroke: the EXCITE randomized clinical trial. JAMA. 2006 Nov 1;296(17):2095-104. doi: 10.1001/jama.296.17.2095.

    PubMed 17077374
  • Hatem SM, Saussez G, Della Faille M, Prist V, Zhang X, Dispa D, Bleyenheuft Y. Rehabilitation of Motor Function after Stroke: A Multiple Systematic Review Focused on Techniques to Stimulate Upper Extremity Recovery. Front Hum Neurosci. 2016 Sep 13;10:442. doi: 10.3389/fnhum.2016.00442. eCollection 2016.

    PubMed 27679565
  • Stevenson T, Thalman L, Christie H, Poluha W. Constraint-Induced Movement Therapy Compared to Dose-Matched Interventions for Upper-Limb Dysfunction in Adult Survivors of Stroke: A Systematic Review with Meta-analysis. Physiother Can. 2012 Fall;64(4):397-413. doi: 10.3138/ptc.2011-24.

    PubMed 23997396
  • Demers M, Fung K, Subramanian SK, Lemay M, Robert MT. Integration of Motor Learning Principles Into Virtual Reality Interventions for Individuals With Cerebral Palsy: Systematic Review. JMIR Serious Games. 2021 Apr 7;9(2):e23822. doi: 10.2196/23822.

    PubMed 33825690
  • Somville M, Rosselli Z, Ducoffre E, Arnould C, Bleyenheuft Y, Saussez G. Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE@home) for Adults With Chronic Stroke: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Feb 10;15:e87035. doi: 10.2196/87035.

    PubMed 41666310

Questions about this trial

What is this clinical trial studying?

A study testing Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) implemented at the patient home, Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and Follow-up Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) at the patient's home 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 4 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: looking for participants now, as of the sponsor's last update on 9 May 2023. 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?

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, Phd, Prof. (+32 486 91 99 11, 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 in upper and lower extremities sensorimotor functions assess by the Fugl-Meyer Assessment (FMA). (time frame: Baseline, 2 weeks and 12 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 NCT05727111, which also lists 5 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 9 May 2023.

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