NCT04403464

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

May 26, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

2.5 years

First QC Date

May 20, 2020

Last Update Submit

June 14, 2022

Conditions

Cerebral Palsy

Keywords

motor skill learningintensive therapyselective voluntary motor controlcerebral palsyassistive technologytherapeutic device

Outcome Measures

Primary Outcomes (2)

  • 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.

    pre-camp (1 week before), post-camp (1 week after), 3 months follow- up

  • 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).

    pre-camp (1 week before), post-camp (1 week after), 3 months follow- up

Secondary Outcomes (22)

  • Changes in Test of Arm Selective Control (TASC)

    pre-camp (1 week before), post-camp (1 week after), 3 months follow- up

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

    pre-camp (1 week before), post-camp (1 week after), 3 months follow- up

  • Changes in 6 Minutes Walking Test (6MWT)

    pre-camp (1 week before), post-camp (1 week after), 3 months follow- up

  • Changes in Box and Blocks test (BBT)

    pre-camp (1 week before), post-camp (1 week after), 3 months follow- up

  • Changes in Jebsen-Taylor Test

    pre-camp (1 week before), post-camp (1 week after), 3 months follow- up

  • +17 more secondary outcomes

Study Arms (2)

HABIT-ILE with REAtouch®

EXPERIMENTAL

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

Behavioral: HABIT-ILE with REAtouch®

HABIT-ILE without REAtouch®

ACTIVE COMPARATOR

Hand and Arm Bimanual Intensive Therapy Including Lower Extremities

Behavioral: HABIT-ILE without REAtouch®

Interventions

HABIT-ILE with REAtouch®BEHAVIORAL

65h HABIT-ILE including 30h REAtouch®

HABIT-ILE with REAtouch®
HABIT-ILE without REAtouch®BEHAVIORAL

65h HABIT-ILE

HABIT-ILE without REAtouch®

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Neuroscience, UCLouvain

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Yannick Bleyenheuft, Professor

    Institute of Neuroscience, UCLouvain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yannick Bleyenheuft, Professor

CONTACT

+32 2 764 93 49yannick.bleyenheuft@uclouvain.be

Seyma Kilcioglu, PhD Student

CONTACT

seyma.kilcioglu@student.uclouvain.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 20, 2020

First Posted

May 27, 2020

Study Start

May 26, 2020

Primary Completion

November 20, 2022

Study Completion

December 20, 2022

Last Updated

June 15, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)