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A Comparison Between the Exoskeleton Hybrid Assistive Limb and Conventional Gait Training Early After Stroke (HAL-RCT)

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ClinicalTrials.gov Identifier: NCT02410915
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : May 18, 2017
Sponsor:
Collaborator:
University of Tsukuba
Information provided by (Responsible Party):
Susanne Palmcrantz, Danderyd Hospital

Brief Summary:
Overall aim is to evaluate HAL for gait training early after stroke and the effect of HAL on short- and long-term functioning, disability and health compared to conventional gait training as part of an inpatient rehabilitation program early after stroke.

Condition or disease Intervention/treatment Phase
Stroke Gait, Hemiplegic Ambulation Difficulty Hemiparesis Device: Hybrid Assistive Limb (HAL); gait training Other: Control Group; Conventional gait training Not Applicable

Detailed Description:

To compare outcome after 4 weeks of gait training with HAL vs. 4 weeks of conventional gait training as part of a regular inpatient rehabilitation program for hemiparetic patients with severely limited mobility early after stroke.

Study design: Randomized, controlled study with blinded outcome assessment.

Conventional gait training is individualized and performed according to current practice (approximately 30-60 minutes/session, 5 days a week) and may include standing, weight shifting, stepping, over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support. Conventional gait training is offered to both study groups.

Training with HAL is performed in 1 session per day, 4 days per week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective time). Training with HAL is performed in combination with body-weight support system and on a treadmill. The training program is performed by 2 physiotherapists, who have been trained in the HAL method.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gait Training Early After Stroke - a Comparison Between Training With the Exoskeleton Hybrid Assistive Limb and Conventional Gait Training
Study Start Date : February 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Study Group
Intervention: Hybrid Assistive Limb (HAL); gait training in combination with conventional training. Training with the exosceleton Hybrid Assistive Limb (HAL) is performed in 1 session per day, 4 days per week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective time). Training with HAL is performed in combination with body-weight support system and on a treadmill. The training program is performed by 2 physiotherapists, who have been trained in the HAL method.
Device: Hybrid Assistive Limb (HAL); gait training
Training with HAL is performed in 1 session per day, 4 days per week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective time). Training with HAL is performed in combination with body-weight support system and on a treadmill. The training program is performed by 2 physiotherapists, who have been trained in the HAL method.
Other Name: Hybrid Assistive Limb (HAL)

Active Comparator: Control Group
Intervention: Conventional gait training is individualized and performed according to current practice (approximately 30-60 minutes/session, 5 days a week) and may include standing, weight shifting, stepping, over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support. Conventional gait training is offered to both study groups.
Other: Control Group; Conventional gait training
Conventional gait training is individualized and performed according to current practice (approximately 30-60 minutes/session, 5 days a week) and may include standing, weight shifting, stepping, over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support. Conventional gait training is offered to both study groups.




Primary Outcome Measures :
  1. Change in Functional Ambulation Categories (FAC) [ Time Frame: Assessed at baseline, after 4 weeks of training and 6 months after stroke ]
    Level of independence in walking, range 0-5


Other Outcome Measures:
  1. Change in Gait Deviation Index (GDI) [ Time Frame: After 4 weeks of training and 6 months after stroke ]
    Gait pattern function will be assessed using a motion capture system (Vicon MX40, Oxford, UK) with two force plates (Kistler, Winterthur, Switzerland) and wireless surface electromyography (EMG, Noraxon, Scottsdale, Arizona, USA). Markers will be placed according to a conventional full-body model (Vicon Plug-in-Gait) and surface EMGs, according to standardized electrode placement (www.seniam.org).

  2. Change in GDI-kinetic. [ Time Frame: After 4 weeks of training and 6 months after stroke ]
    Gait pattern function will be assessed using a motion capture system (Vicon MX40, Oxford, UK) with two force plates (Kistler, Winterthur, Switzerland) and wireless surface electromyography (EMG, Noraxon, Scottsdale, Arizona, USA). Markers will be placed according to a conventional full-body model (Vicon Plug-in-Gait) and surface EMGs, according to standardized electrode placement (www.seniam.org).

  3. Change in Barthel Index [ Time Frame: Assessed at baseline, after 4 weeks of training and 6 months after stroke ]
    Independence in mobility and personal care

  4. Change in Fugl-Meyer for Lower extremities [ Time Frame: Assessed at baseline, after 4 weeks of training and 6 months after stroke ]
    Sensory and motor function in lower extremities

  5. Change in Berg Balance scale [ Time Frame: Assessed at baseline, after 4 weeks of training and 6 months after stroke ]
    Balance

  6. Change in Modified Aschworth scale [ Time Frame: Assessed at baseline, after 4 weeks of training and 6 months after stroke ]
    Spasticity

  7. Change in 2 minutes walk test [ Time Frame: Assessed at baseline, after 4 weeks of training and 6 months after stroke ]
    Walking

  8. Change in Alberts test [ Time Frame: Assessed at baseline, after 4 weeks of training and 6 months after stroke ]
    Neglect

  9. Change in EQ5D [ Time Frame: Assessed at baseline, after 4 weeks of training and 6 months after stroke ]
    Health outcome

  10. Stroke impact scale [ Time Frame: 6 months after stroke ]
    Functioning and disability



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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • less than 8 weeks since stroke onset; inability to walk independently due to lower extremity paresis (i.e. FAC score 0-1), able to sit on a bench with or-without supervision at least five minutes; sufficient postural control to allow upright position in standing with aids and/or manual support; ability to understand training instructions as well as written and oral study information and to express informed consent; body size compatible with the HAL suit.

Exclusion Criteria:

  • contracture restricting gait movements at any lower limb joint; cardiovascular or other somatic condition incompatible with intensive gait training; and severe, contagious infections.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410915


Locations
Sweden
Department of Rehabilitation Medicine, Danderyd Hospital
Danderyd, Stockholm, Sweden, 18288
Sponsors and Collaborators
Danderyd Hospital
University of Tsukuba
Investigators
Principal Investigator: Jörgen Borg, Professor Department of Rehabilitation medicine, Danderyd Hospital, Karolinska Institute

Publications:
Responsible Party: Susanne Palmcrantz, PhD, Reg. Physiotherapist, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT02410915     History of Changes
Other Study ID Numbers: 2013/1807-31/2
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017

Keywords provided by Susanne Palmcrantz, Danderyd Hospital:
Rehabilitation
Robotics

Additional relevant MeSH terms:
Stroke
Paresis
Gait Disorders, Neurologic
Mobility Limitation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms