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

Not yet recruiting

Phase 3 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 main specific aims are:
- to demonstrate the effect of training with HAL as part of current, best available, regular inpatient rehabilitation in comparison with the effect of current, best available regular inpatient rehabilitation programs only, in the post acute phase (starting 4-7 weeks) after stroke with regard to gait and cardio-vascular function, activity and participation;
- to explore factors that predict outcome/good responders to training with HAL;
- to estimate health care utilisation and cost effectiveness of using the HAL during the first year after stroke.

Detailed Description

The primary aim is to evaluate the effectiveness of:
- training with HAL as part of regular inpatient rehabilitation starting 4-7 weeks after stroke
- regular inpatient rehabilitation only, on independence in ambulation after intervention by comparing the Functional Ambulation Category in each group.
Secondary aims comprise the effectiveness of training with HAL on independence gait function and quality, cardiovascular function, activity of daily living and participation assessed at the end of intervention and at a 6 and 12 months follow-up. Effects on health care consumption during 12 months after the intervention will be explored and treatment related adverse events during the study will be documented. Further, associations between spasticity versus HAL mediated recovery will also be explored.
Intensive gait training with 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). During the 4 weeks the patients will also receive conventional gait training provided by regular staff at the clinic. After the intervention, conventional in-patient training continues until the patient is discharged to home-based rehabilitation. To standardize the training procedure, training with HAL is performed on a treadmill and to enable body weight support. Body weight support is used to prevent falls and to unburden the weight of the suit (9 kg). The training program is performed by physiotherapists, trained in the HAL method and the study procedures.
The control group will receive conventional gait training, 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.

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

Sponsors