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

Gait Training Early After Stroke - a Comparison Between Training With the Exoskeleton Hybrid Assistive Limb and Conventional Gait Training

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Hemiparesis; Gait, Hemiplegic; Ambulation Difficulty
• Intervention / Treatment: Device: Hybrid Assistive Limb (HAL); gait training; Other: Control Group; Conventional gait training

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
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm
    • Danderyd, Stockholm, Sweden, 18288
      • Department of Rehabilitation Medicine, Danderyd Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Ambulation Categories (FAC)	Level of independence in walking, range 0-5	Assessed at baseline, after 4 weeks of training and 6 months after stroke

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gait Deviation Index (GDI)	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).	After 4 weeks of training and 6 months after stroke
Change in GDI-kinetic.	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).	After 4 weeks of training and 6 months after stroke
Change in Barthel Index	Independence in mobility and personal care	Assessed at baseline, after 4 weeks of training and 6 months after stroke
Change in Fugl-Meyer for Lower extremities	Sensory and motor function in lower extremities	Assessed at baseline, after 4 weeks of training and 6 months after stroke
Change in Berg Balance scale	Balance	Assessed at baseline, after 4 weeks of training and 6 months after stroke
Change in Modified Aschworth scale	Spasticity	Assessed at baseline, after 4 weeks of training and 6 months after stroke
Change in 2 minutes walk test	Walking	Assessed at baseline, after 4 weeks of training and 6 months after stroke
Change in Alberts test	Neglect	Assessed at baseline, after 4 weeks of training and 6 months after stroke
Change in EQ5D	Health outcome	Assessed at baseline, after 4 weeks of training and 6 months after stroke
Stroke impact scale	Functioning and disability	6 months after stroke

Collaborators and Investigators

• Sponsor: Danderyd Hospital
• Collaborators: University of Tsukuba
• Investigators: Principal Investigator: Jörgen Borg, Professor, Department of Rehabilitation medicine, Danderyd Hospital, Karolinska Institute

Publications and helpful links

General Publications

• Nilsson A, Vreede KS, Haglund V, Kawamoto H, Sankai Y, Borg J. Gait training early after stroke with a new exoskeleton--the hybrid assistive limb: a study of safety and feasibility. J Neuroeng Rehabil. 2014 Jun 2;11:92. doi: 10.1186/1743-0003-11-92.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: February 13, 2015
• First Submitted That Met QC Criteria: April 2, 2015
• First Posted (Estimate): April 8, 2015

Study Record Updates

• Last Update Posted (Actual): May 18, 2017
• Last Update Submitted That Met QC Criteria: May 17, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Rehabilitation; Robotics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Paresis; Gait Disorders, Neurologic; Mobility Limitation
• Other Study ID Numbers: 2013/1807-31/2