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

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 intensive training with HAL in comparison with intensive training without HAL and with standard care only, in a later phase (1-10 years) after stroke with regard to gait and cardio-vascular function, activity and participation;
- to estimate health care utilisation and cost effectiveness of using the HAL during the first year after stroke.

Detailed Description

The primary aim of the study is to compare the effectiveness of:
- intensive training with HAL,
- intensive training without HAL and
- standard training, in a later phase (1-10 years) after stroke 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 range of movement, strength and spasticity versus HAL mediated recovery will also be explored.
Intensive gait training with HAL is performed 1 session/day, 3 days/week for 6 weeks and each session will not exceed 60 min of effective walking time with HAL. In addition, each session will include conventional gait training that will not exceed 30 min effective training time. 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. At the end of the 6 weeks, the physiotherapist that has been engaged in the patient's conventional training will perform 1-2 home visits to inform/educate the patient and those who are providing assistance to the patient in how the patient can make use of any gains in gait function during activities of daily living.
The 1st control group will receive conventional gait training performed 1 session/day, 3 days/week for 6 weeks that will not exceed 1h 30 min effective training time.
The 2nd control group will not receive an intervention. 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

Conditions

Interventions

  • Hybrid Assistive Limb (HAL) Device
    Intervention Desc: Intensive gait training with Hybrid Assistive Limb (HAL) is performed 1 session/day, 3 days/week for 6 weeks and each session will not exceed 60 min of effective walking time with HAL. In addition, each session will include conventional gait training that will not exceed 30 min effective training time.
    ARM 1: Kind: Experimental
    Label: Study group Hybrid Assistive Limb (HAL)
    Description: .
  • 1st control group Other
    Intervention Desc: Conventional gait training performed 1 session/day, 3 days/week for 6 weeks that will not exceed 1h 30 min effective training time.
    ARM 1: Kind: Experimental
    Label: 1st control group
    Description: .
  • 2nd control group Other
    Intervention Desc: The 2nd control group will not receive an intervention.
    ARM 1: Kind: Experimental
    Label: 2nd control group
    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) Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Fugl Meyer Scale for lower extremities Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Modified Ashworth Scale Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Spasticity measured with Neuroflexor foot module Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Berg Balance Scale Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary 10 meters walk test Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary 2 minutes walk test Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary 6 minutes walk test Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Borg Rating of Perceived Exertion Scale (RPE) Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Montreal Cognitive Assessment Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Hospital anxiety and Depression Scale Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Barthel Index Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Stroke Impact Scale Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Physical activity in everyday life using SenseWear Assessment at baseline, after 3 weeks of intervention, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Gait Deviation Index (GDI) (Laboratory gait analysis) Assessment at baseline, after 6 weeks of intervention and 6 month post intervention No
Secondary Objectively quantify the impairment caused by a stroke, using the National Institutes of Health Stroke Scale (NIHSS) Assessment at baseline No
Secondary Modified Ranking Scale Assessment at baseline No
Secondary Body Mass Index Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Weight Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Height Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Blood pressure Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary HbA1c Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Plasma lipid profile Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Perception of the intervention after 6 weeks of intervention No
Secondary Energy expenditure during the 6 weeks of intervention No
Secondary Smoking Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Alcohol Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Drug use Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention No
Secondary Health care consumption 12 month post intervention No
Secondary Stroke type and localization At baseline No
Secondary Dysexecutive Questionnaire At baseline No

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