A Comparison Between the Exoskeleton Hybrid Assistive Limb and Conventional Gait Training Early After Stroke

Stroke Clinical Trial

— HAL-RCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02410915
• Other study ID #: 2013/1807-31/2
• Status: Completed
• Phase: N/A
• First received: February 13, 2015
• Last updated: May 17, 2017
• Start date: February 2014
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Danderyd Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ambulation Difficulty
• Gait Disorders, Neurologic
• Gait, Hemiplegic
• Hemiparesis
• Mobility Limitation
• Paresis
• Stroke

Intervention

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:
• 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.

Locations

Country	Name	City	State
Sweden	Department of Rehabilitation Medicine, Danderyd Hospital	Danderyd	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Danderyd Hospital	University of Tsukuba

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Nilsson A, Vreede KS, Häglund 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Change in Barthel Index	Independence in mobility and personal care	Assessed at baseline, after 4 weeks of training and 6 months after stroke
Other	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
Other	Change in Berg Balance scale	Balance	Assessed at baseline, after 4 weeks of training and 6 months after stroke
Other	Change in Modified Aschworth scale	Spasticity	Assessed at baseline, after 4 weeks of training and 6 months after stroke
Other	Change in 2 minutes walk test	Walking	Assessed at baseline, after 4 weeks of training and 6 months after stroke
Other	Change in Alberts test	Neglect	Assessed at baseline, after 4 weeks of training and 6 months after stroke
Other	Change in EQ5D	Health outcome	Assessed at baseline, after 4 weeks of training and 6 months after stroke
Other	Stroke impact scale	Functioning and disability	6 months after stroke
Primary	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