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

NCT05740605 | Recruiting

• 1 other identifier: B4032022000142a
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Cerebral Palsy

Keywords

HABIT-ILE; Intensive therapy based on motor skill learning; Home rehabilitation; Caregiver; Telerehabilitation

Outcome Measures

Primary Outcomes (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)

  baseline, 2 weeks and 12 weeks after baseline

Secondary Outcomes (17)

• Changes in the Both Hand Assessment (BOHA)

  baseline, 2 weeks and 12 weeks after baseline

• Changes in gross unimanual dexterity by the Box and block test (BBT)

  baseline, 2 weeks and 12 weeks after baseline

• Changes in the Six Minutes' Walk Test (6MWT)

  baseline, 2 weeks and 12 weeks after baseline

• Changes in activities of daily living assessed by ABILHAND-Kids questionnaires.

  baseline, 2 weeks and 12 weeks after baseline

• Changes in activities of daily living assessed by PEDI questionnaire

  baseline, 2 weeks and 12 weeks after baseline

Study Arms (4)

HABIT-ILE therapy at home without 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 usual care

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 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

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 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 usual care

Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE); Behavioral: Usual Care

Classic HABIT-ILE therapy with follow-up HABIT-ILE 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

Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE); Behavioral: Follow-up Hand-Arm Bimanual Intensive Therapy Including Lower Extremities

Interventions

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

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.

Classic HABIT-ILE therapy with follow-up HABIT-ILE at home; Classic HABIT-ILE therapy without follow-up HABIT-ILE at home

Hand-Arm Bimanual Intensive Therapy Including Lower Extremities at home BEHAVIORAL

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.

Also known as: HABIT-ILE@home

HABIT-ILE therapy at home with a HABIT-ILE follow-up at home; HABIT-ILE therapy at home without a HABIT-ILE follow-up at home

Follow-up Hand-Arm Bimanual Intensive Therapy Including Lower Extremities BEHAVIORAL

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.

Also known as: Follow-up HABIT-ILE@home

Classic HABIT-ILE therapy with follow-up HABIT-ILE at home; HABIT-ILE therapy at home with a HABIT-ILE follow-up at home

Usual Care BEHAVIORAL

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

Also known as: Customary care

Classic HABIT-ILE therapy without follow-up HABIT-ILE at home; HABIT-ILE therapy at home without a HABIT-ILE follow-up at home

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

MSL-IN Lab, Institue of Neurosciences, UCLouvain

Brussels, Belgium

RECRUITING

Related Publications (5)

• 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.

  PMID: 32086598 BACKGROUND

• 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.

  PMID: 31501133 BACKGROUND

• 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.

  PMID: 25271469 BACKGROUND

• 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.

  PMID: 33825690 BACKGROUND

• 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.

  PMID: 26183338 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Yannick Bleyenheuft, Phd, Prof.

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The primary aim, the GMFM, will be videotaped and the scoring will be done by a blind evaluator. In secondary outcomes, the BoHA will be blind scored.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 23, 2023
• Study Start: February 22, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)