Clinical trial NCT06931795: Implementation of a HABIT-ILE Intervention at William Lennox Neurological Hospital (NeuREHA) - Adult
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: stroke, intensive intervention, motor skill learning, subacute
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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..

Eligibility criteria: Inclusion Criteria:

* Phase aiguë ou subaiguë

Exclusion Criteria:

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

Primary outcomes:
measure: Changes on the Adult Assisting Hand Assessment Stroke (Ad-AHA Stroke)
timeFrame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Secondary outcomes:
measure: Changes in upper extremities sensorimotor functions assess by the Fugl-Meyer Assessment (FMA-UE)
timeFrame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
measure: Changes in unimanual dexterity: Box and Blocks test (BBT)
timeFrame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
measure: Changes in Canadian Occupational Performance Measure (COPM)
timeFrame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
measure: Changes in the Stroke Impact Scale (SIS)
timeFrame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
measure: Changes in activities of daily living assessed by ACTIVLIM-Stroke Questionnaire
timeFrame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
measure: Changes in activities of daily living assessed by ABILHAND Questionnaire
timeFrame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
measure: Changes in visual neglect assessed by the Bells Test
timeFrame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
measure: Changes in the Montreal Cognitive Assessment (MoCA) test
timeFrame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
measure: Changes in balance control assessed by the mini Balance Evaluation System Test (mini BEST test)
timeFrame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
measure: Changes in the Two Minutes' Walk Test (2MWT)
timeFrame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
measure: Changes in National Institutes of Health Stroke Scale (NIHSS)
timeFrame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
measure: Changes in Tardieu Scale et Modified Tardieu Scale (MTS)
timeFrame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)
measure: Changes in EQ-5D-5L
timeFrame: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Other outcomes:
Locations:
city: Brussels,
country: Belgium
facility: Institute of Neurosciences, UCLouvain
city: Brussels
country: Belgium
facility: Institute of Neurosciences, UCLouvain
city: Bruxelles,
country: Belgium
facility: Spontaneous contact via doctors or other partners
Study officials:
affiliation: Insititue of Neurosciences, UCLouvain
name: Yannick Bleyenheuft, PT, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
References: