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

Primary Purpose

Acquired Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
HABIT-ILE
Conventional intervention
Sponsored by
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Brain Injury focused on measuring motor skill learning, executive function, activity of daily living, intensive therapy, acquired brain injury

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Hospitalier Neurologique William LennoxRecruiting
  • Institute of Neurosciences, UCLouvainRecruiting
  • Spontaneous contact via doctors or other partnersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HABIT-ILE

Conventional intervention

Arm Description

Hand and arm bimanuel intensive therapy including lowers extremities

Conventional physical and occupational therapy

Outcomes

Primary Outcome Measures

Flanker task
Cognitive functions of the children will be assessed by Flanker task.
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.

Secondary Outcome Measures

Changes in isometric muscular strength (Jamar)
A quantitative and objective measure of isometric muscular strength of hand and forearm.
Stroop task
Executive functions of the children will be assessed by Stroop task.
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.
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
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.
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.
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)
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).
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).
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).
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.
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).
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.
QUALITY OF LIFE : KIDSCREEN 10
The Gross Motor Function Classification System - Expanded & Revised (GMFCS - E&R)

Full Information

First Posted
June 2, 2023
Last Updated
June 15, 2023
Sponsor
Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT05900778
Brief Title
Implementation of a HABIT-ILE Intervention at William Lennox Neurological Hospital (NeuREHA)
Acronym
NeuREHA
Official Title
Implementation of a HABIT-ILE Intervention at William Lennox Neurological : a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2023 (Actual)
Primary Completion Date
December 20, 2024 (Anticipated)
Study Completion Date
June 10, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury
Keywords
motor skill learning, executive function, activity of daily living, intensive therapy, acquired brain injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HABIT-ILE
Arm Type
Experimental
Arm Description
Hand and arm bimanuel intensive therapy including lowers extremities
Arm Title
Conventional intervention
Arm Type
Active Comparator
Arm Description
Conventional physical and occupational therapy
Intervention Type
Behavioral
Intervention Name(s)
HABIT-ILE
Intervention Description
2 weeks HABIT-ILE
Intervention Type
Behavioral
Intervention Name(s)
Conventional intervention
Intervention Description
2 weeks usual intervention (waitlist group)
Primary Outcome Measure Information:
Title
Flanker task
Description
Cognitive functions of the children will be assessed by Flanker task.
Time Frame
T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Title
Changes in Gross Motor Function Measurement (GMFM 66)
Description
The GMFM has been developed to measure the change in gross motor function over time in children with cerebral palsy.
Time Frame
T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Secondary Outcome Measure Information:
Title
Changes in isometric muscular strength (Jamar)
Description
A quantitative and objective measure of isometric muscular strength of hand and forearm.
Time Frame
T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Title
Stroop task
Description
Executive functions of the children will be assessed by Stroop task.
Time Frame
T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Title
Changes in unimanual dexterity: Box and Blocks test (BBT)
Description
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.
Time Frame
T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Title
Changes on bimanual function (Assisting Hand Assessment (AHA))
Description
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
Time Frame
T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Title
Changes in 6 Minutes Walking Test (6MWT)
Description
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.
Time Frame
T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Title
Changes in Pediatric balance scale (PBS)
Description
A 14-item criterion-referencekd measure that examines functional balance in the context of everyday tasks in the pediatric population.
Time Frame
T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Title
Changes in Canadian Occupational Performance Measure (COPM)
Description
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)
Time Frame
T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Title
Changes in ACTIVLIM-CP questionnaire
Description
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).
Time Frame
T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Title
Changes in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)
Description
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).
Time Frame
T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Title
Changes in Pediatric quality of life inventory (PedsQL)
Description
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).
Time Frame
T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Title
Changes in Measure of Processes of Care (MPOC-20)
Description
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.
Time Frame
T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
Title
Status in Wechsler Intelligence Scale for Children-Non verbal short version (WISC)
Description
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).
Time Frame
T0 (baseline)
Title
Classification du niveau moteur: The Gross Motor Function Classification System - Expanded & Revised (GMFCS - E&R)
Description
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.
Time Frame
T0 (baseline)
Title
QUALITY OF LIFE : KIDSCREEN 10
Description
The Gross Motor Function Classification System - Expanded & Revised (GMFCS - E&R)
Time Frame
T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yannick Bleyenheuft, Professor
Phone
+32 2 764 93 49
Email
yannick.bleyenheuft@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Paradis, Doctor
Phone
+32 489 28 12 50
Email
julie.paradis@vinci.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yannick Bleyenheuft, Professor
Organizational Affiliation
Insititue of Neurosciences, UCLouvain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Neurologique William Lennox
City
Ottignies-Louvain-la-Neuve
State/Province
Brabant-Wallon
ZIP/Postal Code
1340
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Klocker, PhD
Email
anne.klocker@vinci.be
Facility Name
Institute of Neurosciences, UCLouvain
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yannick Bleyenheuft, Professor
Phone
+32 2 764 93 49
Email
yannick.bleyenheuft@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Julie Paradis
Phone
+32 489 28 12 50
Email
julie.paradis@vinci.be
Facility Name
Spontaneous contact via doctors or other partners
City
Bruxelles
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
anne Klocker, PhD
Email
anne.klocker@vinci.be

12. IPD Sharing Statement

Plan to Share IPD
No

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

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