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

Sponsor

Danderyd Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02410915

Collaborator

University of Tsukuba (Other)

Enrollment

Location

Arms

38.9

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Feb 1, 2014

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

May 1, 2017

Arms and Interventions

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.

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

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

Outcome Measures

Primary Outcome Measures

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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 67 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.