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Not yet recruiting NCT06931795

Implementation of a HABIT-ILE Intervention at William Lennox Neurological Hospital (NeuREHA) - Adult

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HABIT-ILE, Conventional intervention.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 18 years — 95 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Implementation of a HABIT-ILE Intervention at the William Lennox Neurological Centre for Sub-acute Adult Post-stroke Patients (<6 Mois): a Randomised Controlled Trial

Overview

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

Detailed description

The aim is to investigate, for the first time, the effectiveness of HABIT-ILE therapy in a hospital setting in the treatment of a population representative of the clinical population for adult patients with subacute stroke.

The hypothesis is that an in-hospital HABIT-ILE protocol will be more effective than conventional therapies usually given to patients with sub-acute post-stroke, and that this difference will be objectively demonstrated by clinical assessments of motor function, cognition and participation conducted before and after treatment periods.

The aim of the study is therefore to evaluate the effect of intensive bimanual hand-arm therapy including the lower extremities (HABIT-ILE) on body functions and structures, activity and participation in adulte patients suffering from subacute stroke..

Interventions

  • Behavioral HABIT-ILE
    2 weeks HABIT-ILE
  • Behavioral Conventional intervention
    2 weeks usual intervention (waitlist group)

Primary outcome measures

  • Changes on the Adult Assisting Hand Assessment Stroke (Ad-AHA Stroke) [Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
Secondary outcome measures (12)
  • Changes in upper extremities sensorimotor functions assess by the Fugl-Meyer Assessment (FMA-UE) [Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
  • Changes in unimanual dexterity: Box and Blocks test (BBT) [Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
  • Changes in Canadian Occupational Performance Measure (COPM) [Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
  • Changes in the Stroke Impact Scale (SIS) [Time frame: [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: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
  • Changes in activities of daily living assessed by ABILHAND Questionnaire [Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
  • Changes in visual neglect assessed by the Bells Test [Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
  • Changes in the Montreal Cognitive Assessment (MoCA) test [Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
  • Changes in balance control assessed by the mini Balance Evaluation System Test (mini BEST test) [Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
  • Changes in the Two Minutes' Walk Test (2MWT) [Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
  • Changes in National Institutes of Health Stroke Scale (NIHSS) [Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
  • Changes in Tardieu Scale et Modified Tardieu Scale (MTS) [Time frame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]

Eligibility criteria

Inclusion criteria

  • Phase aiguë ou subaiguë

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Belgium · 3 centers
  • Institute of Neurosciences, UCLouvain — Brussels
  • Institute of Neurosciences, UCLouvain — Brussels
  • Spontaneous contact via doctors or other partners — Brussels

Identifiers

NCT: NCT06931795 · B0392023000045

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗