NCT04664673

Brief Summary

Using a randomized controlled trial design, the possible changes induced by the intensive treatment program "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" will be studied in functional, everyday life activities and neuroplastic assessment of adults with chronic stroke.

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
48

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable stroke

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

December 2, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

1.9 years

First QC Date

December 2, 2020

Last Update Submit

June 16, 2022

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Changes on the Adult Assisting Hand Assessment Stroke (Ad-AHA Stroke)

    This assessment is an observation-based instrument assessing the effectiveness of the spontaneous use of the affected hand when performing bimanual activities in adults post stroke scored in a logit based 0-100 AHA-unit scale (higher score indicate higher ability)

    baseline, 3 weeks and 13 weeks after baseline

Secondary Outcomes (29)

  • Changes on speed/accuracy trade-off during a bimanual reaching task (bi-SAT)

    baseline, 3 weeks and 13 weeks after baseline

  • Changes on force during a bimanual reaching task (bi-Force)

    baseline, 3 weeks and 13 weeks after baseline

  • Changes on bimanual coordination during a bimanual reaching task (bi-CO)

    baseline, 3 weeks and 13 weeks after baseline

  • Changes on bimanual smoothness during a bimanual reaching task (bi-smoothness)

    baseline, 3 weeks and 13 weeks after baseline

  • Changes on errors during a bimanual reaching task (bi-error)

    baseline, 3 weeks and 13 weeks after baseline

  • +24 more secondary outcomes

Study Arms (2)

HABIT-ILE

EXPERIMENTAL

HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) intervention during two weeks adapted for adults stroke survivors

Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)

Regular care

ACTIVE COMPARATOR

Usual customary treatment for adults stroke survivors during two weeks

Behavioral: Regular care

Interventions

Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)BEHAVIORAL

motor learning-based, intensive therapy originally developed for hemiplegic children.

Also known as: HABIT-ILE Stroke
HABIT-ILE
Regular careBEHAVIORAL

customary or usual treatment given to any adult stroke survivor

Also known as: Usual care
Regular care

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hemiparetic patient with a chronic stroke (over 6 months of evolution)
  • age 40 to 90 years old inclusive
  • ability to follow instructions and complete testing according to the age.

You may not qualify if:

  • alcohol/drug abuse
  • pregnancy
  • major cognitive impairment interfering with the study (severe aphasia, psychiatric conditions)
  • uncontrolled health issues (cardiac/renal failure)
  • contraindications to perform MRI assessments (Metal implants, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Neuroscience, UCLouvain

Brussels, 1200, Belgium

RECRUITING

Related Publications (1)

  • Ebner-Karestinos D, Gathy E, Carton de Tournai A, Herman E, Araneda R, Dricot L, Macq B, Vandermeeren Y, Bleyenheuft Y. Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in adults with chronic stroke: protocol of a randomised controlled trial. BMJ Open. 2023 Apr 13;13(4):e070642. doi: 10.1136/bmjopen-2022-070642.

    PMID: 37055214DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yves Vandermeeren, MD,PhD

    Institute of Neuroscience, UCLouvain; CHU-UCL Namur, Neurology Department, UCLouvain

    PRINCIPAL INVESTIGATOR

  • Yannick Bleyenheuft, PhD

    MSL-IN Lab, Institute of Neuroscience, UCLouvain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yves Vandermeeren, PhD

CONTACT

+3281423321yves.vandermeeren@uclouvain.be

Daniela Ebner, PhD

CONTACT

+3227645446daniela.ebner@uclouvain.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Allocation
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2020

First Posted

December 11, 2020

Study Start

December 15, 2020

Primary Completion

November 1, 2022

Study Completion

December 1, 2023

Last Updated

June 21, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)