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Cerebral PalsyHABITILEhomeNCT05740605

Implementation of a HABIT-ILE Intervention at Home for Children With Bilateral Cerebral Palsy

A study testing Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE), Hand-Arm Bimanual Intensive Therapy Including Lower Extremities at home and Follow-up Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in people with Cerebral Palsy, 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

Intensive interventions based on the principles of motor skill learning, like Hand-Arm Bimanual Therapy Including Lower Extremities (HABIT-ILE), have demonstrated excellent effectiveness in improving motor function and daily life independence of children with cerebral palsy (CP). Read more about this study

Who is it for?
Ages 5 to 18 years
Conditions the study is for
Cerebral Palsy
What is being tested?
Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE), Hand-Arm Bimanual Intensive Therapy Including Lower Extremities at home and Follow-up Hand-Arm Bimanual Intensive Therapy Including Lower Extremities
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteBelgium
Study dates
22 Feb 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 5 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Children with confirmed diagnosis of bilateral Cerebral Palsy
  • Age 5 to 18 years old
  • Ability to interact and understand simple instructions in order to complete assessments and therapy
  • Availability of a caregiver for 6h30 per day during two weeks of therapy

Who cannot join

  • Uncontrolled 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
  • Any typical contraindication for MRI

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

Zélie Rosselli, Phd student contact

+33 6 82 59 79 38

zelie.rosselli@uclouvain.be

Belgium1 site, 1 recruiting
  • MSL-IN Lab, Institue of Neurosciences, UCLouvain

    Brussels

    Zélie Rosselli, PT, +32 2 764 54 46, contact-mslin@uclouvain.be

    Recruiting

Other trials in Belgium

About this study

Official title: Implementation of a HABIT-ILE at Home Intervention for Children With Bilateral Cerebral Palsy: a Non-inferiority Randomized Controlled Trial

Intensive interventions based on the principles of motor skill learning, like Hand-Arm Bimanual Therapy Including Lower Extremities (HABIT-ILE), have demonstrated excellent effectiveness in improving motor function and daily life independence of children with cerebral palsy (CP). Patients living far from big cities do not have easy access to such interventions, usually applied in the form of camps. This randomized controlled trial will include 48 children with bilateral CP and aims to test a home version of HABIT-ILE with the use of a specifically designed virtual device and a remote supervision. For this purpose, two types of two weeks intensive treatment programs will be compared: Hand and Arm Bimanual Intensive Therapy Including Lower Extremities at home ("HABIT-ILE at home") and "classic HABIT-ILE". Moreover, this study also aims to assess whether the patient's abilities are better with a follow-up at home after two weeks of HABIT-ILE therapy than without follow-up post therapy. Four groups will be compared: HABIT-ILE at home therapy with a follow-up at home, HABIT-ILE at home therapy without follow-up, classic HABIT-ILE therapy with a follow-up at home and classic HABIT-ILE therapy without follow-up. Children will be assessed at 3 time points: before therapy, after therapy and 3 months after the start of therapy.

Read the detailed description

Cerebral Palsy (CP) is the most common cause of physical disability in children: it occurs in 1 to nearly 4 children in 1000 newborns worldwide. This major public health issue caused by abnormal brain development or damage during brain development result in different symptoms that vary from one patient to another. Even if all children with CP will develop motor symptoms (abnormal movement patterns and posture) some of them will also develop non-motor symptoms such as pain (75%), intellectual deficits (50%), language disorders (25%), epilepsy (25%), behavioral and sleep disorders (20-25%). The consequences of these symptoms are very variable and result in long-term functional deficits in the activities of daily living, such as dressing, eating, going to the bathroom, etc. To improve these patients' autonomy, intensive therapies based on motor skill learning (MSL) have been shown to be especially effective. Among these therapies, Hand-Arm Bimanual Intensive Therapy including Lower Extremities (HABIT-ILE) has been developed over the last decade in the MSL-IN laboratory of UCLouvain and has shown impressive improvements in children with CP. It is based on an intensive training of bimanual activities, with a systematic inclusion of lower limbs and trunk motor control. This therapy is given in the form of a rehabilitation camp of at least 50 hours on site. Therefore, the implementation of a classic HABIT-ILE, in day-camp requires a great commitment from the families who must travel to the camp location for two weeks of therapy. In addition, for patients living far from big cities or unable to travel, access to these therapies can be really complex. Moreover, these camps are applied in a group of 8-12 children. Each participant is accompanied by at least one therapist (physiotherapist or occupational therapist and sometimes student) trained in HABIT-ILE therapy. This implies that a HABIT-ILE camp requires minimum 12 trained therapists. Nonetheless, there is a lack of therapists that makes the implementation of these camps still challenging. In addition, the health requirements related to COVID-19 make it difficult to implement any kind of therapy and to assess patients' progress. Therefore, this health crisis has highlighted the importance of being able to offer home-based therapy. To answer the problematics of pandemic, accessibility and of lack of HABIT-ILE therapists, the idea of implementing HABIT-ILE at home was born. How could we implement MSL principles at home? Some of the key components of MSL are intensity, shaping of the task (with part- task and increasing difficulty), goal-oriented therapy, positive reinforcement and hands-off (voluntary movements by the patients, not guided by the therapist). To incorporate those principles and ensure the validity of the therapy, guidance by a trained HABIT-ILE supervisor is necessary. This supervision will be provided through remote telerehabilitation sessions. Virtual reality is well suited to implement MSL-IN principles and allows for remote communication with patients. Tele-reeducation devices are numerous: from classic commercials video game found in stores to devices made for rehabilitation. Alone these devices do not allow the implementation of all the principles of motor skill learning but with the supervision of therapists trained in HABIT-ILE supervision, this objective could be achieved. With the help of new technologies, will the HABIT-ILE supervisors be able to implement HABIT-ILE at home in a reliable and standardized way for children with CP aged 6 to 18 ? This RCT aims to assess if HABIT-ILE at home is not inferior to HABIT-ILE in camp regarding physical abilities, functional activities and participation of the participants.

Moreover, if the maintenance of skills during HABT-ILE camp at 3- and 6-months post-therapy has been proven, the question of improving them has not been investigated yet. Indeed, we know that in order to maintain the skills learned during the HABIT-ILE therapy, it is necessary to practice them on a daily basis. If a skill is not used it will lead to a cortical reorganization of the motor cortex at the expense of this skill. Thus, there is a persistent cycle of decreased utilization that leads to unfavorable cortical reorganization that leads to decreased utilization, etc. It is called "learned non-use". In order to reduce this phenomenon and thus improve the transfer of the HABIT-ILE skills into the daily life of the children, we wonder about the benefit of a post-therapy follow-up. Once again, the use of tele-rehabilitation can provide us a solution of daily delocalized therapy directly implemented at the patient's home and supervised remotely. Could the transfer of learned skills be improved with a follow-up at home post therapy? In order to answer this question, after the two weeks of both HABIT-IL modality, we will set up a HABIT-ILE telerehabilitation follow-up for 9 weeks. This study therefore also aims to assess if the patient's abilities could be potentialize with a follow-up than without a follow-up after two weeks of HABIT-ILE therapy.

Conditions
Cerebral Palsy
Being tested
Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE), Hand-Arm Bimanual Intensive Therapy Including Lower Extremities at home, Follow-up Hand-Arm Bimanual Intensive Therapy Including Lower Extremities, Usual Care
Keywords
HABIT-ILE, Intensive therapy based on motor skill learning, Home rehabilitation, Caregiver, Telerehabilitation
Medical subject headings
Cerebral Palsy

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)Behavioural

    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. This therapy has shown impressive improvements in children with PC.

  • Hand-Arm Bimanual Intensive Therapy Including Lower Extremities at 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.

  • Follow-up Hand-Arm Bimanual Intensive Therapy Including Lower ExtremitiesBehavioural

    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 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 NCT05740605
Study groupRoleWhat they receive
HABIT-ILE therapy at home without 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 usual care
Receives: Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities at home; Behavioral: Usual Care
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 at home; Behavioral: Follow-up Hand-Arm Bimanual Intensive Therapy Including Lower Extremities
Classic HABIT-ILE therapy without follow-up HABIT-ILE at homeActive 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 follow-up HABIT-ILE 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

What is being measured

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

  1. Change on Gross Motor Function (GMFM-66)

    Developed to assess the changes in gross motor function of children with cerebral palsy (scored in percentage)

    Measured: baseline, 2 weeks and 12 weeks after baseline

Secondary outcomes (17)
  1. Changes in the Both Hand Assessment (BOHA)

    The BoHA aims to measure the effective use of both hands in bimanual activity performance, as well as to quantify the possible side difference between hands. (score in percentage)

    Measured: baseline, 2 weeks and 12 weeks after baseline

  2. Changes in gross unimanual dexterity by the Box and 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

  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 activities of daily living assessed by ABILHAND-Kids questionnaires.

    ABILHAND-Kids is a questionnaire that measures manual ability for children with upper limb impairments. The scale measures a person's ability to manage daily activities that require the use of the upper limbs, whatever the strategies involved. ABILHAND-Kids has been validated in cerebral palsy children (age 6-15). 21 manual activities perceived by the children parents. Each item is answered on a 3-level scale (impossible, difficult, easy). The item difficulty increases with bimanual involvement: higher score means better performance

    Measured: baseline, 2 weeks and 12 weeks after baseline

  5. Changes in activities of daily living assessed by PEDI questionnaire

    This parent's filled questionnaire measures the performance of the child in the daily life activities and movement domains, focusing on the capacity of upper extremities and lower extremities during these activities. It ranges from 0 to 100% (higher score means better performance)

    Measured: baseline, 2 weeks and 12 weeks after baseline

  6. Changes in activities of daily living assessed by ACTIVLIM-CP Questionnaire

    This parent's filled questionnaire measures a patient's ability to perform daily activities requiring the use of the upper and/or the lower extremities through 43 items specific to patients with cerebral palsy. It ranges from - 7 to +7 logits (higher score means better performance)

    Measured: baseline, 2 weeks and 12 weeks after baseline

  7. Changes in activities of locomotion assessed by ABILOCO-Kids Questionnaire

    The ABILOCO-Kids questionnaire is a measure of locomotion ability for children with lower limb impairments. The scale has been calibrated in children with cerebral palsy (age 6-15). The Parent is asked to fill in the questionnaire by estimating their child's ease or difficulty in performing each activity. During the evaluation, the 3-level response scale is presented to the parent. The parent is asked to rate his/her perception on the response scale as 'Impossible', 'Difficult' or 'Easy'. The activities not attempted by the child within the last 3 months are not scored and are entered as not applicable (check the question mark '?' on the scoring sheet). The activities that the child does not perform because they are too difficult must be scored as 'Impossible'. (higher score means better performance)

    Measured: baseline, 2 weeks and 12 weeks after baseline

  8. Changes in the fine motor skills and functional activities of the hand assessed by the Jebsen Hand Fuction Test

    The Jebsen Hand Function Test (JHFT) assesses fine motor skills, weighted and non-weighted hand function activities during performance of activities of daily living. The JHFT consists of 6 items that measure: (a) fine motor skills; (b) weighted functional tasks; and (c) non-weighted functional tasks:

    Turning over a 3×5-inch card Picking up small common objects Simulated feeding Stacking checkers Picking up large light cans Picking up large heavy cans

    Measured: baseline, 2 weeks and 12 weeks after baseline

  9. Changes in self-esteem assessed by the ESTIMILL-CP questionnaire

    The ESTIMILL-CP is self-completed by the children. It consists of 26 illustrated items where the child must choose between "I identify with the situation" or "I don't identify with the situation" and then whether it's "a lot of similarity" or "not much". The lower the score, the worse the self-esteem.

    Measured: baseline, 2 weeks and 12 weeks after baseline

  10. Changes in the PILS-CP questionnaire.

    The PILS-CP questionnaire self-administrated (patients do not realize the life situation). Patients are asked to estimate the involvement 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 am not involved", "I am a little bit involved", "I am fully involved". Life situations that the patients do not want to be involve are rated with "?"

    Measured: baseline, 2 weeks and 12 weeks after baseline

  11. Changes in lower limbs physical activity

    With a movement sensor on each wrist and on the 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

  12. Changes in upper limbs physical activity

    With a movement sensor on each wrist and on the 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

  13. Changes in the functional goals assessed by the Canadian Occupational Performance Measure (COPM) questionnaire.

    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

  14. Changes in 3D T1-weighted structural imaging.

    This sequence allows to measure changes in gray matter (cortical thickness)

    Measured: baseline, 2 weeks and 12 weeks after baseline

  15. Changes on the Fractional Anisotropy (Diffusion tensor imaging (DTI))

    This sequence allows to measure changes in the fractional anisotropy (FA) on the white matter tracts. FA is a scalar value (no unit) between zero and one that describes the degree of anisotropy of white matter water molecules.

    Measured: baseline, 2 weeks and 12 weeks after baseline

  16. Changes on RS-fMRI

    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

    Measured: baseline, 2 weeks and 12 weeks after baseline

  17. Changes on the Mean Diffusivity (Diffusion tensor imaging (DTI))

    This sequence allows to measure the mean changes in the diffusivity (MD). MD is a scalar value (no unit) between zero and one that describes the degree of molecular diffusion.

    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 posted23 Feb 2023
  2. Study start22 Feb 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
NCT05740605
Sponsor's protocol ID
B4032022000142a
Acronym
HABITILEhome
Status last verified
Mar 2023
First submitted
2 Feb 2023
Last updated
6 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

Publications

  • Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.

    PubMed 32086598
  • Sakzewski L, Bleyenheuft Y, Boyd RN, Novak I, Elliott C, Reedman S, Morgan C, Pannek K, Fripp J, Golland P, Rowell D, Chatfield M, Ware RS. Protocol for a multisite randomised trial of Hand-Arm Bimanual Intensive Training Including Lower Extremity training for children with bilateral cerebral palsy: HABIT-ILE Australia. BMJ Open. 2019 Sep 8;9(9):e032194. doi: 10.1136/bmjopen-2019-032194.

    PubMed 31501133
  • Bleyenheuft Y, Gordon AM. Hand-arm bimanual intensive therapy including lower extremities (HABIT-ILE) for children with cerebral palsy. Phys Occup Ther Pediatr. 2014 Nov;34(4):390-403. doi: 10.3109/01942638.2014.932884. Epub 2014 Oct 1.

    PubMed 25271469
  • 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
  • Bleyenheuft Y, Dricot L, Gilis N, Kuo HC, Grandin C, Bleyenheuft C, Gordon AM, Friel KM. Capturing neuroplastic changes after bimanual intensive rehabilitation in children with unilateral spastic cerebral palsy: A combined DTI, TMS and fMRI pilot study. Res Dev Disabil. 2015 Aug-Sep;43-44:136-49. doi: 10.1016/j.ridd.2015.06.014. Epub 2015 Jul 13.

    PubMed 26183338
  • Rosselli Z, Somville M, Ducoffre E, Arnould C, Bleyenheuft Y, Saussez G. HABIT-ILE@home for Children With Bilateral Cerebral Palsy: Protocol for Noninferiority and Superiority Randomized Controlled Trials. JMIR Res Protoc. 2026 Aug 11;15:e89872. doi: 10.2196/89872.

    PubMed 42579610

Questions about this trial

What is this clinical trial studying?

A study testing Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE), Hand-Arm Bimanual Intensive Therapy Including Lower Extremities at home and Follow-up Hand-Arm Bimanual Intensive Therapy Including Lower Extremities in people with Cerebral Palsy, 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 6 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 6 Mar 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?

Change on Gross Motor Function (GMFM-66) (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 NCT05740605, which also lists 6 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 6 Mar 2023.

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