NCT05900778

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
26mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

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

Study Progress58%
Jun 2023Jun 2028

First Submitted

Initial submission to the registry

June 2, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

June 10, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2028

Expected
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

1.5 years

First QC Date

June 2, 2023

Last Update Submit

June 15, 2023

Conditions

Acquired Brain Injury

Keywords

motor skill learningexecutive functionactivity of daily livingintensive therapyacquired brain injury

Outcome Measures

Primary Outcomes (2)

  • Flanker task

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

    T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)

  • 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)

Secondary Outcomes (14)

  • Changes in isometric muscular strength (Jamar)

    T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)

  • Stroop task

    T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)

  • Changes in unimanual dexterity: Box and Blocks test (BBT)

    T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)

  • Changes on bimanual function (Assisting Hand Assessment (AHA))

    T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)

  • Changes in 6 Minutes Walking Test (6MWT)

    T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)

  • +9 more secondary outcomes

Study Arms (2)

HABIT-ILE

EXPERIMENTAL

Hand and arm bimanuel intensive therapy including lowers extremities

Behavioral: HABIT-ILE

Conventional intervention

ACTIVE COMPARATOR

Conventional physical and occupational therapy

Behavioral: Conventional intervention

Interventions

HABIT-ILEBEHAVIORAL

2 weeks HABIT-ILE

HABIT-ILE
Conventional interventionBEHAVIORAL

2 weeks usual intervention (waitlist group)

Conventional intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre Hospitalier Neurologique William Lennox

Ottignies-Louvain-la-Neuve, Brabant-Wallon, 1340, Belgium

RECRUITING

Institute of Neurosciences, UCLouvain

Brussels, 1200, Belgium

RECRUITING

Spontaneous contact via doctors or other partners

Brussels, Belgium

RECRUITING

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Yannick Bleyenheuft, Professor

    Insititue of Neurosciences, UCLouvain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yannick Bleyenheuft, Professor

CONTACT

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

Julie Paradis, Doctor

CONTACT

+32 489 28 12 50julie.paradis@vinci.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

June 2, 2023

First Posted

June 13, 2023

Study Start

June 10, 2023

Primary Completion

December 20, 2024

Study Completion (Estimated)

June 10, 2028

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(3)