Back to results

Effect of a New Interactive Device on the Motor and Functional Abilities of Children With Bilateral Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status

Recruiting

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

HABIT-ILE with REAtouch®

HABIT-ILE without REAtouch®

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring motor skill learning, intensive therapy, selective voluntary motor control, cerebral palsy, assistive technology, therapeutic device

Eligibility Criteria

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

Inclusion Criteria:

Diagnosed bilateral cerebral palsy,
MACS levels from I to III,
GMFCS levels from I to III,
Ability to follow instructions and complete testing.

Exclusion Criteria:

Orthopedic surgery, botulinum toxin injections or another unusual intervention less than 6 months before or within the study period.
Unstable seizure
Severe visual or cognitive impairments likely to interfere with intervention or testing session completion

Sites / Locations

Institute of Neuroscience, UCLouvainRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HABIT-ILE with REAtouch®

HABIT-ILE without REAtouch®

Arm Description

Hand and Arm Bimanual Intensive Therapy Including Lower Extremities with an interactive device

Hand and Arm Bimanual Intensive Therapy Including Lower Extremities

Outcomes

Primary Outcome Measures

Changes in Gross Motor Function Measure (GMFM-66):

The GMFM has been developed to measure the change in gross motor function over time in children with cerebral palsy.

Changes in ABILHAND-Kids Questionnaire

This ABILHAND-Kids Questionnaire has been developed to assess a child's unimanual and bimanual upper limb activities. It ranges from - 6 to +6 logits (higher score means better performance).

Secondary Outcome Measures

Changes in Test of Arm Selective Control (TASC)

The TASC is an upper limb selective motor control evaluation tool including eight motions in each arm and up to three attempts are allowed for each motion. After completion of the best attempt, points ranging from 0 (absent), 1 (impaired) to 2 (normal) are recorded for each joint depending on the movement properties and descriptors of the test.

Changes in Selective Control Assessment of the Lower Extremity (SCALE)

The SCALE was designed to evaluate lower limb selective motor control of children with cerebral palsy. The SCALE includes testing of five reciprocal lower extremity movements. SVMC is graded at each joint as 'Normal' (2 points), 'Impaired' (1 point), or 'Unable' (0 points).

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 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 in Jebsen-Taylor Test

The Jebsen-Taylor Test assesses uni-manual hand function, through 7 subtests simulating daily life activities. The test assesses speed, not quality of performance and time to complete each activity is reported using a stopwatch.

Changes in Modified Cooper test

The Modified Cooper test is a modified version of The Manual Form Perception Test, which evaluates stereognosis through 16 objects. Both hands are tested separately and time to recognise the objects is reported using a stopwatch.

Changes in ACTIVLIM-CP Questionnaire

The ACTIVLIM-CP Questionnaire measures a patient's ability to perform daily activities requiring the use of the upper and/or the lower limbs through 42 items specific to patients with cerebral palsy. It ranges from - 5 to +5 logits (higher score means better performance).

Changes in ABILOCO-Kids Questionnaire

The ABILOCO-Kids Questionnaire measures a patient's ability to perform daily activities requiring the use of the lower limbs through 10 items specific to patients with cerebral palsy. It ranges from - 4 to +4 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 Canadian Occupational Performance Measure (COPM)

The COPM measures the patient's self-perception of occupational performance and satisfaction of it in daily activities over time. It ranges from 1 to 10 (higher score means better performance).

Changes in Both Hands Assessment (BoHA)

The BoHA is a videotaped tool measuring how effectively children with bilateral CP use both hands in bimanual activities.

Changes in Executive Functions

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

Changes in spatial parameters of the gait (Kinematics assessments)

Through a 3D motion system, we measure the stride length (meters), step length (meters) and step width (meters).

Changes in temporal parameters of the gait (Cycle time)

Through a 3D motion system, we measure the cycle of gait time (seconds).

Changes in temporal parameters of the gait (Stance time)

Through a 3D motion system, we measure the stance time (percentage of the total gait cycle).

Changes in temporal parameters of the gait (Swing time)

Through a 3D motion system, we measure the swing time (percentage of the total gait cycle).

Changes in temporal parameters of the gait (Stride)

Through a 3D motion system, we measure the gait cadence (stride per minute).

Changes in temporal parameters of the gait (Velocity)

Through a 3D motion system, we measure the gait velocity (meter/second).

Changes in temporal parameters of the gait (Acceleration)

Through a 3D motion system, we measure the gait acceleration (meters/second^2).

Changes in spatial parameters of the upper extremity (Straightness)

Through a 3D motion system, we measure the straightness (percentage of upper extremity trajectory during a reaching task).

Changes in spatial parameters of the upper extremity (Smoothness)

Through a 3D motion system, we measure the smoothness (variability of the movement during a reaching task)

Changes in temporal parameters of the upper extremity (Kinematics assessments)

Through a 3D motion system, we measure the time from onset to end of the task (seconds). the task consists in a reaching task.

Full Information

NCT ID

NCT04403464

First Posted

May 20, 2020

Last Updated

June 14, 2022

Sponsor

Université Catholique de Louvain

1. Study Identification

Unique Protocol Identification Number

NCT04403464

Brief Title

Effect of a New Interactive Device on the Motor and Functional Abilities of Children With Bilateral Cerebral Palsy

Official Title

The Effect of Using a New Interactive Device Based on Motor Skill Learning Principles on the Motor and Functional Abilities of Children With Bilateral Cerebral Palsy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 26, 2020 (Actual)

Primary Completion Date

November 20, 2022 (Anticipated)

Study Completion Date

December 20, 2022 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Recent research has shown that interventions with assistive technologies lead to an improvement in the motor and functional abilities of children with cerebral palsy (CP). REAtouch® is a new interactive interface based on motor skill learning principles. Its efficiency during intensive motor skill learning interventions has never been tested in children with bilateral cerebral palsy. Therefore, the study aims to investigate the efficiency of using a virtual reality tool to provide a motor skill learning intervention in a randomized trial.

Detailed Description

Recent research has shown that interventions with assistive technologies could lead to an improvement in the motor and functional abilities of children with cerebral palsy (CP). However they usually miss the functional motor skill learning qualities to match the changes observed in high intensity motor skill learning based interventions.REAtouch® is a new interactive interface based on motor skill learning principles that could be implemented in intensive interventions. Therefore, the study aims to investigate the effects of intensive interventions with or without the interface on the motor and functional abilities of children with bilateral CP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

Keywords

motor skill learning, intensive therapy, selective voluntary motor control, cerebral palsy, assistive technology, therapeutic device

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HABIT-ILE with REAtouch®

Arm Type

Experimental

Arm Description

Hand and Arm Bimanual Intensive Therapy Including Lower Extremities with an interactive device

Arm Title

HABIT-ILE without REAtouch®

Arm Type

Active Comparator

Arm Description

Hand and Arm Bimanual Intensive Therapy Including Lower Extremities

Intervention Type

Behavioral

Intervention Name(s)

HABIT-ILE with REAtouch®

Intervention Description

65h HABIT-ILE including 30h REAtouch®

Intervention Type

Behavioral

Intervention Name(s)

HABIT-ILE without REAtouch®

Intervention Description

65h HABIT-ILE

Primary Outcome Measure Information:

Title

Changes in Gross Motor Function Measure (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