New Technology for Individualised, Intensive Training of Gait After Stroke Study I "HAL-RCT-II"

Recruiting

Phase N/A Results N/A

Trial Description

The overall purpose of this project is to establish the added value of training with the Hybrid Assistive Limb (HAL) exoskeleton system as part of regular rehabilitation intervention programs after stroke.
The aim of this study is to explore if HAL training when combined with conventional training in the subacute stage after stroke may accelerate the recovery of independence in walking when compared to conventional training only and if recovery is related to stroke lateralization?

Detailed Description

Patients will be randomized using a block randomization by a nurse, who is not otherwise involved in the study, into either 1) HAL training in addition to the conventional program or 2) evidence based conventional gait training only. The block randomization will be designed so that an even number of patients with left and right sided hemiparesis will have been included in each group at the end of the study.
Conventional training (including gait practice) will be performed according to current best practice (approximately 30-60 min per day, 5 days per week) and may include stepping, weight shifting, over ground walking as well as the use of a treadmill with/without body weight support (BWS).
HAL training will be performed 4 days a week for 4 weeks (i.e. 16 sessions) with the single-leg version of HAL, primarily by use of the voluntary HAL-mode (CVC mode), on a treadmill with BWS. The therapist(s) educated in the HAL method will optimize the HAL settings for each individual during each session, in order to obtain a symmetrical gait pattern as close to normal gait as possible.
Outcomes The primary outcome will be changes in the FAC-score during the intervention. FAC assesses activity in terms of independence in walking on a six-grade-ordinal-scale ranging from non-functional walking to independent walking outside. During the intervention assessments with the FAC will be performed weekly by the patients' physiotherapist responsible for conventional rehabilitation. This therapist will otherwise not be involved in the study.
Secondary outcomes include aspects of body functions assessed by use of the NIH Stroke Scale, Albert's test, Fugl-Meyer Assessment(FMA-LE) and the Modified Ashworth Scale for the lower extremities.
Activities and Participation will be assessed by use of Functional Ambulation Categories, 2 minutes walk test in self-preferred speed, Berg Balance Scale, Barthel Index and EQ5D.
Patients' perception of training will be assessed by a study specific questionnaire.
Adverse events (such as irritated skin, pain, falls) will be documented continuously in the study protocol according to a specific study form.
Assessments will be performed 1) before and 2) after the intervention with 3) a follow up at 6 months.

Conditions

Interventions

  • Conventional gait training Other
    Intervention Desc: The conventional gait training is performed according to current best evidence based practice and may include over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support and training of gait function in activities of daily living.
    ARM 1: Kind: Experimental
    Label: Conventional gait training
    Description: .
  • Hybrid Assistive Limb (HAL) Device
    Intervention Desc: Intensive gait training with Hybrid Assistive Limb (HAL) is performed, 1 session/day, 4 days/week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective walking time with HAL).
    ARM 1: Kind: Experimental
    Label: Hybrid Assistive Limb (HAL)
    Description: .

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in Functional Ambulation Categories (FAC) Assessed at baseline, after 6 weeks of intervention, 6 month and 12 month post intervention No
Secondary Gait DeviationIndex (GDI) (Laboratory gait analysis) Assessed after 6 weeks of intervention, 6 month post intervention No
Secondary Barthel Index Assessed at baseline, after 6 weeks of intervention, 6 month post intervention No
Secondary Fugl-Meyer for Lower extremities Assessed at baseline, after 6 weeks of intervention, 6 month post intervention No
Secondary Berg Balance scale Assessed at baseline, after 6 weeks of intervention, 6 month and 12 month post intervention No
Secondary Spasticity using Modified Aschworth Scale Assessed at baseline, after 6 weeks of intervention, 6 month and 12 month post intervention No
Secondary 10 meters walk test Assessed at baseline, after 6 weeks of intervention, 6 month and 12 month post intervention No
Secondary 2 Minutes Walk Test (MWT) Assessed at baseline, after 6 weeks of intervention, 6 month and 12 month post intervention No
Secondary 6 Minutes Walk Test (MWT) Assessed at baseline, after 6 weeks of intervention, 6 month and 12 month post intervention No
Secondary Stroke Impact Scale (SIS) Assessed at baseline, after 6 weeks of intervention, 6 month and 12 month post intervention No
Secondary Montreal Cognitive Assessment Assessed at baseline and 12 month post intervention No
Secondary Hospital anxiety and Depression Scale Assessed at baseline and 12 month post intervention No
Secondary physical activity using SenseWear Assessed at baseline, during 6 weeks of intervention, 6 month and 12 month post intervention No
Secondary Borg Rating of Perceived Exertion (RPE) Assessed at baseline, after 6 weeks of intervention, 6 month and 12 month post intervention No
Secondary Modified Ranking Scale At baseline No
Secondary Perception of the intervention after 6 weeks of intervention No
Secondary Objectively quantify the impairment caused by a stroke, using the National Institutes of Health Stroke Scale (NIHSS) At baseline No
Secondary Spasticity using Neuroflexor foot module At baseline No
Secondary Drug use At baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Alcohol At baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Smoking At baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Body Mass Index At baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Weight At baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Height At baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Blood pressure At baseline, after 6 weeks of intervention and 12 month post intervention No
Secondary Plasma lipid profile At baseline, after 6 weeks of intervention and 12 month post intervention No
Secondary HbA1c At baseline, after 6 weeks of intervention and 12 month post intervention No
Secondary Stroke type and localization At baseline No
Secondary Health care consumption From after 6 weeks of intervention to 12 month post intervention No
Secondary Energy expenditure During 6 weeks of intervention No
Secondary Albert's test Assessed at baseline
Secondary EQ-5D Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention

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