Cerebral Palsy Clinical Trial
— HABITILEhomeOfficial 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.
Status | Recruiting |
Enrollment | 48 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 18 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | MSL-IN Lab, Institue of Neurosciences, UCLouvain | Brussels |
Lead Sponsor | Collaborator |
---|---|
Université Catholique de Louvain |
Belgium,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | baseline, 2 weeks and 12 weeks after baseline | |
Secondary | 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) | baseline, 2 weeks and 12 weeks after baseline | |
Secondary | 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 | baseline, 2 weeks and 12 weeks after baseline | |
Secondary | 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 | baseline, 2 weeks and 12 weeks after baseline | |
Secondary | 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) | baseline, 2 weeks and 12 weeks after baseline | |
Secondary | 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) | baseline, 2 weeks and 12 weeks after baseline | |
Secondary | 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) | baseline, 2 weeks and 12 weeks after baseline | |
Secondary | 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 |
baseline, 2 weeks and 12 weeks after baseline | |
Secondary | 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. | baseline, 2 weeks and 12 weeks after baseline | |
Secondary | 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 "?" | baseline, 2 weeks and 12 weeks after baseline | |
Secondary | 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). | During the 2 weeks of therapy | |
Secondary | 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). | During the 2 weeks of therapy | |
Secondary | 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) | baseline, 2 weeks and 12 weeks after baseline | |
Secondary | Changes in 3D T1-weighted structural imaging. | This sequence allows to measure changes in gray matter (cortical thickness) | baseline, 2 weeks and 12 weeks after baseline | |
Secondary | 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. | baseline, 2 weeks and 12 weeks after baseline | |
Secondary | 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 | baseline, 2 weeks and 12 weeks after baseline | |
Secondary | 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. | baseline, 2 weeks and 12 weeks after baseline |
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