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.
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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 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.
Belgium1 site, 1 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| HABIT-ILE therapy at home with a HABIT-ILE follow-up at home | Experimental | 2 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 care | Experimental | 2 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 care | Active comparator | 2 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 home | Active comparator | 2 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.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted14 Feb 2023
- Study start1 May 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
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, Phd, Prof., Principal investigator, Université Catholique de Louvain
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 17077374Hatem 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 27679565Stevenson 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 23997396Demers 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 33825690Somville 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
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a HABIT-ILE Intervention at Home for Individuals With Chronic Stroke: a Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05727111
- Acronym / sponsor ID
- HABITILEhome / B4032022000142b
- Conditions
- Stroke
- Keywords
- HABIT-ILE, Intensive therapy based on motor skill learning, Home rehabilitation, Caregiver, Chronic Stroke, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Feb 2023 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| HABIT-ILE therapy at home with a HABIT-ILE follow-up at home | Experimental | 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 home2 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 |
| HABIT-ILE therapy at home followed by usual care | Experimental | Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) implemented at the patient home, Behavioral: Usual care2 weeks of HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) therapy at home followed by 9 weeks of usual care |
| Classic HABIT-ILE therapy followed by usual care | Active comparator | Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE), Behavioral: Usual care2 weeks of classic HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) therapy on site followed by 9 weeks of usual care |
| Classic HABIT-ILE therapy with HABIT-ILE follow-up at home | Active comparator | 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 home2 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) implemented at the patient homeAlso: HABIT-ILE@homeThe 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. | Behavioural | HABIT-ILE therapy at home followed by usual care, HABIT-ILE therapy at home with a HABIT-ILE follow-up at home |
| Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)Also: Classic HABIT-ILEHABIT-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. | Behavioural | Classic HABIT-ILE therapy followed by usual care, Classic HABIT-ILE therapy with HABIT-ILE follow-up at home |
| Follow-up Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) at the patient's homeAlso: Follow-up HABIT-ILE@homeHABIT-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). | Behavioural | Classic HABIT-ILE therapy with HABIT-ILE follow-up at home, HABIT-ILE therapy at home with a HABIT-ILE follow-up at home |
| Usual careAlso: Customary careUsual care is all the weekly physiotherapy and occupational therapy sessions that the patient usually receives. | Behavioural | Classic HABIT-ILE therapy followed by usual care, HABIT-ILE therapy at home followed by usual care |
Primary outcome
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
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).
13 secondary outcomes
Changes in upper extremities motor functions assess by the Wolf Motor Function Test (WMFT)
Time frame: Baseline, 2 weeks and 12 weeks after baseline
Changes in balance control assessed by the mini Balance Evaluation System Test (mini BEST test)
Time frame: Baseline, 2 weeks and 12 weeks after baseline
Changes in the Six Minutes' Walk Test (6MWT)
Time frame: Baseline, 2 weeks and 12 weeks after baseline
Changes in unimanual dexterity assessed by the Box & Block test (BBT)
Time frame: Baseline, 2 weeks and 12 weeks after baseline
Changes in lower limbs physical activity
Time frame: During the 2 weeks of therapy
Changes in upper limbs physical activity
Time frame: During the 2 weeks of therapy
Changes in Canadian Occupational Performance Measure (COPM)
Time frame: Baseline, 2 weeks and 12 weeks after baseline
Changes in activities of daily living assessed by ABILHAND Questionnaire
Time frame: Baseline, 2 weeks and 12 weeks after baseline
Changes in activities of daily living assessed by ACTIVLIM-Stroke Questionnaire
Time frame: Baseline, 2 weeks and 12 weeks after baseline
Changes in the modified Rankin Scale (mRS) for neurologic disability
Time frame: Baseline, 2 weeks and 12 weeks after baseline
Changes in the Stroke Impact Scale (SIS)
Time frame: Baseline, 2 weeks and 12 weeks after baseline
Changes in the SATIS-STROKE scale
Time frame: Baseline, 2 weeks and 12 weeks after baseline
Changes in the PILS-STROKE scale
Time frame: Baseline, 2 weeks and 12 weeks after baseline
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 9 May 2023.
- Background: PubMed 17077374Wolf 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.
- Background: PubMed 27679565Hatem 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.
- Background: PubMed 23997396Stevenson 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.
- Background: PubMed 33825690Demers 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.
- Derived from this study: PubMed 41666310Somville 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yannick Bleyenheuft, Phd, Prof. principal investigator
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) 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.