Implementation of a HABIT-ILE Intervention at William Lennox Neurological Hospital (NeuREHA)

Sponsor

Université Catholique de Louvain (Other)

Overall Status

Recruiting

CT.gov ID

NCT05900778

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

13.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Using a randomized controlled trial design, in an hospital environment, possible changes induced by the "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" treatment program will be investigated in functional activities of daily living, motor and cognitive assessment of children with acquired brain injury.

Condition or Disease	Intervention/Treatment	Phase
Acquired Brain Injury	Behavioral: HABIT-ILE Behavioral: Conventional intervention	N/A

Detailed Description

The aim is to investigate, for the first time, the effectiveness of HABIT-ILE therapy in a hospital setting in the treatment of a population representative of the clinical population with children with acquired brain injuries.

The hypothesis is that an in-hospital HABIT-ILE protocol will be more effective than conventional therapies usually given to children with acquired brain injury, and that this difference will be objectively demonstrated by clinical assessments of motor function, cognition and participation conducted before and after treatment periods.

The aim of the study is therefore to evaluate the effect of intensive bimanual hand-arm therapy including the lower extremities (HABIT-ILE) on body functions and structures, activity and participation in children with acquired brain injury.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Implementation of a HABIT-ILE Intervention at William Lennox Neurological : a Randomized Controlled Trial

Actual Study Start Date :

Jun 10, 2023

Anticipated Primary Completion Date :

Dec 20, 2024

Anticipated Study Completion Date :

Jun 10, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HABIT-ILE Hand and arm bimanuel intensive therapy including lowers extremities	Behavioral: HABIT-ILE 2 weeks HABIT-ILE
Active Comparator: Conventional intervention Conventional physical and occupational therapy	Behavioral: Conventional intervention 2 weeks usual intervention (waitlist group)

Arm

Intervention/Treatment

Experimental: HABIT-ILE

Hand and arm bimanuel intensive therapy including lowers extremities

Behavioral: HABIT-ILE

2 weeks HABIT-ILE

Active Comparator: Conventional intervention

Conventional physical and occupational therapy

Behavioral: Conventional intervention

2 weeks usual intervention (waitlist group)

Outcome Measures

Primary Outcome Measures

Flanker task [T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Cognitive functions of the children will be assessed by Flanker task.
Changes in Gross Motor Function Measurement (GMFM 66) [T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
The GMFM has been developed to measure the change in gross motor function over time in children with cerebral palsy.

Secondary Outcome Measures

Changes in isometric muscular strength (Jamar) [T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
A quantitative and objective measure of isometric muscular strength of hand and forearm.
Stroop task [T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Executive functions of the children will be assessed by Stroop task.
Changes in unimanual dexterity: Box and Blocks test (BBT) [T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
The BBT is a test of gross manual dexterity. Each hand is tested individually and the BBT is scored through the number of blocks carried over the partition from one part to another part of a box during the one-minute trial period.
Changes on bimanual function (Assisting Hand Assessment (AHA)) [T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Developed to observe the efficacy of the assisting hand use, in children with unilateral cerebral palsy (scored in percentage), during bimanual activities for the randomized controlled trial
Changes in 6 Minutes Walking Test (6MWT) [T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
The 6 Minutes Walking Test measures the distance that the patient walk as much as possible within a period of 6-minutes in a 30 meters long corridor.
Changes in Pediatric balance scale (PBS) [T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
A 14-item criterion-referencekd measure that examines functional balance in the context of everyday tasks in the pediatric population.
Changes in Canadian Occupational Performance Measure (COPM) [T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
This is an interview-setting designed to capture a patient's self-perception of performance and satisfaction of it in everyday activities, observed over time. During the interview, parents set up 5 activities considered difficult in daily life. These are then assessed, in a 1 to 10 scale, regarding the child'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; higher score means better performance/satisfaction)
Changes in ACTIVLIM-CP questionnaire [T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
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).
Changes in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) [T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
The PEDI-CAT is the new version of the Pediatric Evaluation of Disability Inventory (PEDI). The PEDI-CAT is comprised of 276 functional activities acquired throughout infancy, childhood and young adulthood. Based on the nternational Classification of Functioning, Disability and Health for Children and Youth (ICF-CY) model, the PEDI-CAT contents provide information about the activities and participation component. It ranges from 0 to 100% (higher score means better performance).
Changes in Pediatric quality of life inventory (PedsQL) [T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
The Pediatric Quality of Life Inventory is a brief measure of health-related quality of life in children and young people. The measure can be completed by parents (the Proxy Report) as well as children and young people (the Self-Report).
Changes in Measure of Processes of Care (MPOC-20) [T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Assesses the parents' perceptions of the care they and their children receive from children's rehabilitation treatment centres. Using a 8-point response scale, parents answer to 20 questions, indicating to what extent they have experienced the events or the situations described. A score of 7 means that they have experienced this aspect to a very great extent, or most of the time. A score of 1 means that they have not experienced this aspect at all. A score of 0 means that the question does not apply to them. There is no total score. However, because the statements are positively worded, higher total scores indicates that needs of the parents are being met to a great extent.
Status in Wechsler Intelligence Scale for Children-Non verbal short version (WISC) [T0 (baseline)]
This is a validated assessment for children aged 4 and over, with subtests such as object assembly, recognition, picture arrangement and fluid reasoning. The brief 15-20 minute version will be used. Scores are given for the full battery and for the subtests (subtest T-scores and percentile ranks).
Classification du niveau moteur: The Gross Motor Function Classification System - Expanded & Revised (GMFCS - E&R) [T0 (baseline)]
The Gross Motor Function Classification System - Expanded & Revised (GMFCS - E&R) is a 5-level classification system that describes the gross motor function of children and youth on the basis of their self-initiated movement with particular emphasis on sitting, walking, and wheeled mobility.
QUALITY OF LIFE : KIDSCREEN 10 [T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
The Gross Motor Function Classification System - Expanded & Revised (GMFCS - E&R)

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

children with acquired brain injury of school
age 5 to 18 years inclusive

Exclusion Criteria:

Unstable seizure
programmed botulinum toxin or orthopedic surgery in the 6 months previous to the intervention, during intervention period or 3months after the intervention time
Severe visual or cognitive impairments likely to interfere with intervention or testing session completion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Neurologique William Lennox	Ottignies-Louvain-la-Neuve	Brabant-Wallon	Belgium	1340
2	Institute of Neurosciences, UCLouvain	Brussels		Belgium	1200
3	Spontaneous contact via doctors or other partners	Bruxelles		Belgium