NCT06931795

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 patients with sub-acute post-stroke

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
8mo left

Started Apr 2025

Geographic Reach
1 country

3 active sites

Status
not yet 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 Progress63%
Apr 2025Dec 2026

First Submitted

Initial submission to the registry

April 9, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2026

Expected
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2026

Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

1.7 years

First QC Date

April 9, 2025

Last Update Submit

April 9, 2025

Conditions

Stroke

Keywords

stroke, intensive intervention, motor skill learning, subacute

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)

    [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]

Secondary Outcomes (13)

  • Changes in upper extremities sensorimotor functions assess by the Fugl-Meyer Assessment (FMA-UE)

    [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]

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

    [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]

  • Changes in Canadian Occupational Performance Measure (COPM)

    [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]

  • Changes in the Stroke Impact Scale (SIS)

    [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]

  • Changes in activities of daily living assessed by ACTIVLIM-Stroke Questionnaire

    [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]

  • +8 more secondary outcomes

Study Arms (2)

HABIT-ILE

EXPERIMENTAL

Hand and arm bimanual intensive therapy including lower extremities

Behavioral: HABIT-ILE

Conventional Intervention

ACTIVE COMPARATOR

Conventional physical and occupational therapy (same amout of hours)

Behavioral: Conventional intervention

Interventions

HABIT-ILEBEHAVIORAL

2 weeks HABIT-ILE

Also known as: HABIT-ILE Stroke
HABIT-ILE
Conventional interventionBEHAVIORAL

2 weeks usual intervention (waitlist group)

Conventional Intervention

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Phase aiguë ou subaiguë

You may not qualify if:

  • Epilepsie instable
  • Absence à déterminer sa volonté à participer
  • Traitement toxine pendant le stage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Institute of Neurosciences, UCLouvain

Brussels, 1200, Belgium

Location

Institute of Neurosciences, UCLouvain

Brussels, Belgium

Location

Spontaneous contact via doctors or other partners

Brussels, Belgium

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yannick Bleyenheuft, PT, PhD, Professor

    Insititue of Neurosciences, UCLouvain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yannick Bleyenheuft, PT, PhD, Professor

CONTACT

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

Fanny Lacour, PT

CONTACT

32471589143fanny.lacour@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

April 9, 2025

First Posted

April 17, 2025

Study Start

April 15, 2025

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

December 24, 2026

Last Updated

April 17, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(3)