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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acquired Brain Injury
• Intervention / Treatment: Behavioral: HABIT-ILE; Behavioral: Conventional intervention

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yannick Bleyenheuft, Professor; Phone Number: +32 2 764 93 49; Email: yannick.bleyenheuft@uclouvain.be
• Study Contact Backup: Name: Julie Paradis, Doctor; Phone Number: +32 489 28 12 50; Email: julie.paradis@vinci.be

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Recruiting
    • Institute of Neurosciences, UCLouvain
    • Contact: Yannick Bleyenheuft, Professor; Phone Number: +32 2 764 93 49; Email: yannick.bleyenheuft@uclouvain.be
    • Contact: Julie Paradis; Phone Number: +32 489 28 12 50; Email: julie.paradis@vinci.be
  • Bruxelles, Belgium
    • Recruiting
    • Spontaneous contact via doctors or other partners
    • Contact: anne Klocker, PhD; Email: anne.klocker@vinci.be
  • Brabant-Wallon
    • Ottignies-Louvain-la-Neuve, Brabant-Wallon, Belgium, 1340
      • Recruiting
      • Centre Hospitalier Neurologique William Lennox
      • Contact: anne Klocker, PhD; Email: anne.klocker@vinci.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in isometric muscular strength (Jamar)	A quantitative and objective measure of isometric muscular strength of hand and forearm.	T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Changes in unimanual dexterity: Box and Blocks test (BBT)	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.	T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Changes on bimanual function (Assisting Hand Assessment (AHA))	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	T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Changes in 6 Minutes Walking Test (6MWT)	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.	T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Changes in Pediatric balance scale (PBS)	A 14-item criterion-referencekd measure that examines functional balance in the context of everyday tasks in the pediatric population.	T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Changes in Canadian Occupational Performance Measure (COPM)	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)	T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Changes in 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).	T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Changes in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)	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).	T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Changes in Pediatric quality of life inventory (PedsQL)	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).	T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Changes in Measure of Processes of Care (MPOC-20)	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.	T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Status in Wechsler Intelligence Scale for Children-Non verbal short version (WISC)	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).	T0 (baseline)
Classification du niveau moteur: The Gross Motor Function Classification System - Expanded & Revised (GMFCS - E&R)	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.	T0 (baseline)
QUALITY OF LIFE : KIDSCREEN 10	The Gross Motor Function Classification System - Expanded & Revised (GMFCS - E&R)	T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Stroop task	Executive functions of the children will be assessed by Stroop task.	T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Investigators: Principal Investigator: Yannick Bleyenheuft, Professor, Insititue of Neurosciences, UCLouvain

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2023
• Primary Completion (Estimated): December 20, 2024
• Study Completion (Estimated): June 10, 2028

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 13, 2023

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: executive function; acquired brain injury; motor skill learning; activity of daily living; intensive therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: B0392023000044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No