NCT01700777

Brief Summary

A randomized control trial of "HABIT-ILE" therapy compared with regular / conventional intervention (same amount of hours). The protocols have been developed on the basis of bimanual therapy (HABIT) developed at Columbia University.

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
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2010

Typical duration for phase_1

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

Study Start

First participant enrolled

November 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

3.2 years

First QC Date

October 2, 2012

Last Update Submit

January 21, 2014

Conditions

Congenital Hemiplegia

Keywords

bimanual traininglower limbintensive rehabilitationregular rehabilitationhemiplegia

Outcome Measures

Primary Outcomes (1)

  • Impairment, disability, participation

    The 3 WHO main domains will be investigated. Impairments will be investigated through force, sensory and manipulation testing (including manipulation with mechanical device). Analysis of lower limb is also included in the protocol. Disabilities will be tested through video-taped assessments and questionnaires. Participation will be assessed through questionnaires.

    4 years

Study Arms (2)

Intensive rehab group

EXPERIMENTAL

A group of children will beneficiate of "HABIT-ILE" treatment in an intensive way (camp) for 90h.

Other: "HABIT-ILE"

Regular treatment group

ACTIVE COMPARATOR

A group of children with hemiplegic cerebral palsy will beneficiate from conventional training at a regular frequency (1 to 6 hours / week) for 90hours.

Other: "HABIT-ILE"

Interventions

"HABIT-ILE"OTHER

90 h of training with "HABIT-ILE", in an intensive rehabilitation camp compared with a regular therapy program (groups are crossed-over afterwards).

Also known as: Bimanual training, HABIT, neurorehabilitation
Intensive rehab groupRegular treatment group

Eligibility Criteria

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

You may qualify if:

  • willingness to enter the research program and the testing procedures

You may not qualify if:

  • uncontrolled epilepsy
  • upper limb injections in the upper limb during the last six months / or intend to receive during the training period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Neurosciences, UCL

Brussels, Brussels Capital, 1200, Belgium

RECRUITING

Related Publications (3)

  • Araneda R, Dricot L, Ebner-Karestinos D, Paradis J, Gordon AM, Friel KM, Bleyenheuft Y. Brain activation changes following motor training in children with unilateral cerebral palsy: An fMRI study. Ann Phys Rehabil Med. 2021 May;64(3):101502. doi: 10.1016/j.rehab.2021.101502. Epub 2021 Mar 22.

    PMID: 33647530DERIVED

  • Bleyenheuft Y, Dricot L, Ebner-Karestinos D, Paradis J, Saussez G, Renders A, De Volder A, Araneda R, Gordon AM, Friel KM. Motor Skill Training May Restore Impaired Corticospinal Tract Fibers in Children With Cerebral Palsy. Neurorehabil Neural Repair. 2020 Jun;34(6):533-546. doi: 10.1177/1545968320918841. Epub 2020 May 14.

    PMID: 32407247DERIVED

  • Bleyenheuft Y, Arnould C, Brandao MB, Bleyenheuft C, Gordon AM. Hand and Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) in Children With Unilateral Spastic Cerebral Palsy: A Randomized Trial. Neurorehabil Neural Repair. 2015 Aug;29(7):645-57. doi: 10.1177/1545968314562109. Epub 2014 Dec 19.

    PMID: 25527487DERIVED

MeSH Terms

Conditions

Hemiplegia

Interventions

Neurological Rehabilitation

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Yannick Bleyenheuft, PhD

    Institute of Neurosciences, UCL

    PRINCIPAL INVESTIGATOR

  • Corinne Bleyenheuft, MD

    Cliniques Universitaires de Mont-Godinne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yannick Bleyenheuft, PhD

CONTACT

+32486919911yannick.bleyenheuft@gmail.com

Corinne Bleyenheuft, MD resp.

CONTACT

corinne.bleyenheuft@uclouvain.be

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific collaborator, Institute of Neuroscience UCL

Study Record Dates

First Submitted

October 2, 2012

First Posted

October 4, 2012

Study Start

November 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

BE(1)