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

New Technology for Individualised, Intensive Training of Gait After Stroke- Phase II Trials, Study I

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 aim of this study is to explore if HAL training when combined with conventional training in the subacute stage after stroke may accelerate the recovery of independence in walking when compared to conventional training only and if recovery is related to stroke lateralization?

Study Overview

• Status: Terminated
• Conditions: Stroke; Hemiparesis; Ambulation Difficulty
• Intervention / Treatment: Device: Hybrid Assistive Limb (HAL); Other: Conventional gait training

Detailed Description

Patients will be randomized using a block randomization by a nurse, who is not otherwise involved in the study, into either 1) HAL training in addition to the conventional program or 2) evidence based conventional gait training only. The block randomization will be designed so that an even number of patients with left and right sided hemiparesis will have been included in each group at the end of the study.

Conventional training (including gait practice) will be performed according to current best practice (approximately 30-60 min per day, 5 days per week) and may include stepping, weight shifting, over ground walking as well as the use of a treadmill with/without body weight support (BWS).

HAL training will be performed 4 days a week for 4 weeks (i.e. 16 sessions) with the single-leg version of HAL, primarily by use of the voluntary HAL-mode (CVC mode), on a treadmill with BWS. The therapist(s) educated in the HAL method will optimize the HAL settings for each individual during each session, in order to obtain a symmetrical gait pattern as close to normal gait as possible.

Outcomes The primary outcome will be changes in the FAC-score during the intervention. FAC assesses activity in terms of independence in walking on a six-grade-ordinal-scale ranging from non-functional walking to independent walking outside. During the intervention assessments with the FAC will be performed weekly by the patients' physiotherapist responsible for conventional rehabilitation. This therapist will otherwise not be involved in the study.

Secondary outcomes include aspects of body functions assessed by use of the NIH Stroke Scale, Albert's test, Fugl-Meyer Assessment(FMA-LE) and the Modified Ashworth Scale for the lower extremities.

Activities and Participation will be assessed by use of Functional Ambulation Categories, 2 minutes walk test in self-preferred speed, Berg Balance Scale, Barthel Index and EQ5D.

Patients' perception of training will be assessed by a study specific questionnaire.

Adverse events (such as irritated skin, pain, falls) will be documented continuously in the study protocol according to a specific study form.

Assessments will be performed 1) before and 2) after the intervention with 3) a follow up at 6 months.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susanne Palmcrantz, PhD; Phone Number: +46709567653; Email: susanne.palmcrantz@ki.se

Study Locations

• Sweden
  • Gothenburg, Sweden, SE-413 46
    • Sahlgrenska University Hospital
  • Stockholm
    • Danderyd, Stockholm, Sweden, SE-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

Patients aged 18-67 will be recruited from 1) the University Department of Rehabilitation Medicine at Danderyd Hospital in Stockholm and 2) Sahlgrenska University Hospital in Gothenburg, where they are admitted to inpatient rehabilitation early after stroke. Inclusion criteria will be: less than 8 weeks since stroke onset; inability to walk independently due to lower extremity paresis (i.e. Functional Ambulation Categories (FAC) score 0-1), able to sit on a bench with or-without supervision at least 5 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 include: 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
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Hybrid Assistive Limb (HAL)	Device: Hybrid Assistive Limb (HAL); Intensive gait training with Hybrid Assistive Limb (HAL) is performed, 1 session/day, 4 days/week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective walking time with HAL).
ACTIVE_COMPARATOR: Conventional gait training	Other: Conventional gait training; 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.

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, weekly, after 4 weeks of intervention and at 6 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objectively quantify the impairment caused by a stroke, using the National Institutes of Health Stroke Scale (NIHSS)		At baseline
Fugl-Meyer for Lower extremities	Sensory and motor function in lower extremities	Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention
Albert's test	Spatial negelct	Assessed at baseline
2 Minutes Walk Test (MWT)	Walking	Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention
Berg Balance scale	Balance	Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention
Barthel Index	Independence in mobility and personal care	Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention
Perception of the intervention	Interview, Study group using Hybrid Assistive Limb (HAL) only.	after 4 weeks of intervention
Stroke Impact Scale (SIS)	Functioning and disability, Interview	Assessed at 6 months after intervention
EQ-5D	Health Outcome	Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention

Collaborators and Investigators

• Sponsor: Danderyd Hospital
• Collaborators: Umeå University; Sahlgrenska University Hospital, Sweden; University of Tsukuba

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.
• Wall A, Borg J, Palmcrantz S. Clinical application of the Hybrid Assistive Limb (HAL) for gait training-a systematic review. Front Syst Neurosci. 2015 Mar 25;9:48. doi: 10.3389/fnsys.2015.00048. eCollection 2015.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): September 1, 2018
• Study Completion (ACTUAL): September 1, 2018

Study Registration Dates

• First Submitted: August 24, 2015
• First Submitted That Met QC Criteria: September 8, 2015
• First Posted (ESTIMATE): September 9, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: April 1, 2018

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; Mobility Limitation
• Other Study ID Numbers: HAL-RCT-Phase II-Study I

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No