HABIT-ILE in Adults With Chronic Stroke (HABIT-ILE Stroke)

NCT ID: NCT04664673

Last Updated: 2022-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-15

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Using a randomized controlled trial design, the possible changes in neuroimaging, motor function, motor learning and everyday life activities of adults with chronic stroke (\> 6 months) after participating of the intensive treatment programme "Hand-arm Bimanual Intensive Therapy Including Lower Extremities" (HABIT-ILE) will be studied. Changes, scored by participants in case of questionnaires and by experts in the case of tests, will be observed comparing participants after their regular care/treatment and after receiving HABIT-ILE. Motor function, learning and daily life activities will be correlated with neuroplastic changes.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Allocation
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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HABIT-ILE

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

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Regular care

Usual customary treatment for adults stroke survivors during two weeks

Group Type ACTIVE_COMPARATOR

Regular care

Intervention Type BEHAVIORAL

customary or usual treatment given to any adult stroke survivor

Interventions

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

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

Intervention Type BEHAVIORAL

Regular care

customary or usual treatment given to any adult stroke survivor

Intervention Type BEHAVIORAL

Other Intervention Names

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HABIT-ILE Stroke Usual care

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.)
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of Mont-Godinne

OTHER

Sponsor Role collaborator

Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yves Vandermeeren, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

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

Yannick Bleyenheuft, PhD

Role: PRINCIPAL_INVESTIGATOR

MSL-IN Lab, Institute of Neuroscience, UCLouvain

Locations

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Institute of Neuroscience, UCLouvain

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Yves Vandermeeren, PhD

Role: CONTACT

+3281423321

Daniela Ebner, PhD

Role: CONTACT

+3227645446

Facility Contacts

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Yannick Bleyenheuft, Pr

Role: primary

+3227645446

Daniela Ebner, PhD

Role: backup

+3227645446

References

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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.

Reference Type DERIVED
PMID: 37055214 (View on PubMed)

Other Identifiers

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B403201316810h

Identifier Type: -

Identifier Source: org_study_id

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