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

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

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 main specific aims are:

(i) to compare potential effects on functioning and disability of gait and mobility training long-term after stroke by comparing A) HAL-training combined with conventional rehabilitation interventions to B) conventional rehabilitation interventions without HAL and to C) no intervention.

Study Overview

• Status: Completed
• Conditions: Stroke; Hemiparesis; Ambulation Difficulty
• Intervention / Treatment: Device: Hybrid Assistive Limb (HAL); Other: 1st control group; Other: 2nd control group

Detailed Description

The effectiveness of the interventions will be assessed in terms aspects of body function, walking ability and endurance as well as level of activity in daily living and participation assessed at the end of intervention and at a 6 and 12 months follow-up.

Intensive gait training with HAL is performed 1 session/day, 3 days/week for 6 weeks and each session will not exceed 60 min of effective walking time with HAL. In addition, each session will include conventional gait training that will not exceed 30 min effective training time. To standardize the training procedure, training with HAL is performed on a treadmill and to enable body weight support. Body weight support is used to prevent falls and to unburden the weight of the suit (9 kg). The training program is performed by physiotherapists, trained in the HAL method and the study procedures. At the end of the 6 weeks, the physiotherapist that has been engaged in the patient's conventional training will perform 1-2 home visits to inform/educate the patient and those who are providing assistance to the patient in how the patient can make use of any gains in gait function during activities of daily living.

The 1st control group will receive conventional gait training performed 1 session/day, 3 days/week for 6 weeks that will not exceed 1h 30 min effective training time.

The 2nd control group will not receive an intervention. 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

• Study Type: Interventional
• Enrollment (Actual): 48
• 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 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1-10 years since stroke onset
• Able to walk but not independently, i.e. need of manual support or close supervision due to lower extremity paresis, FAC score 2-3 or FAC 4 combined with gait speed <0.8m/s according to 10 meter walk test, which corresponds to limitations in community ambulation (Bowden et al 2008)
• Ability to understand training instructions as well as written and oral study information and to express informed consent or by proxy
• 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
• Severe, contagious infections (e.g. Methicillin Resistant Staphylococcus Aureus (MRSA) or Extended Spectrum Beta Lactamase bacteria).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group Hybrid Assistive Limb (HAL)	Device: Hybrid Assistive Limb (HAL); Intensive gait training with Hybrid Assistive Limb (HAL) is performed 1 session/day, 3 days/week for 6 weeks and each session will not exceed 60 min of effective walking time with HAL. In addition, each session will include conventional gait training that will not exceed 30 min effective training time.
Active Comparator: 1st control group	Other: 1st control group; Conventional gait training performed 1 session/day, 3 days/week for 6 weeks that will not exceed 1h 30 min effective training time.
Active Comparator: 2nd control group	Other: 2nd control group; The 2nd control group will not receive an intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 6 min walk test	walking ability and endurance	Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl Meyer Scale for lower extremities	Sensory and motor function in lower extremities	Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Modified Ashworth Scale	Spasticity	Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Spasticity measured with Neuroflexor foot module	Spasticity	Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Berg Balance Scale	Balance	Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
10 meters walk test	Walking	Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
2 minutes walk test	Walking	Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Functional Ambulation Categories	Walking	Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Borg Rating of Perceived Exertion Scale (RPE)	Interview	Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Montreal Cognitive Assessment		Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Hospital anxiety and Depression Scale	Interview	Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Barthel Index	Independence in mobility and personal care	Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Stroke Impact Scale	Functioning and disability, Interview	Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Physical activity in everyday life using SenseWear	Registers physical activity in everyday life	Assessment at baseline, after 3 weeks of intervention, after 6 weeks of intervention, 6 and 12 month post intervention
Objectively quantify the impairment caused by a stroke, using the National Institutes of Health Stroke Scale (NIHSS)	Stroke severity	Assessment at baseline
Modified Ranking Scale	Interview	Assessment at baseline
Body Mass Index		Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Weight		Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Height		Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Blood pressure	Registered in everyday life	Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
HbA1c	Blood test	Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Plasma lipid profile	Blood test	Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Perception of the intervention	Interview. Study group using Hybrid Assistive Limb (HAL) only.	after 6 weeks of intervention
Smoking	Interview	Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Alcohol	Interview	Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Drug use	From medical records	Assessment at baseline, after 6 weeks of intervention, 6 and 12 month post intervention
Health care consumption	From County Council	12 month post intervention
Stroke type and localization	From medical records	At baseline
Dysexecutive Questionnaire	Filled in by significant other	At baseline

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.
• Palmcrantz S, Wall A, Vreede KS, Lindberg P, Danielsson A, Sunnerhagen KS, Hager CK, Borg J. Impact of Intensive Gait Training With and Without Electromechanical Assistance in the Chronic Phase After Stroke-A Multi-Arm Randomized Controlled Trial With a 6 and 12 Months Follow Up. Front Neurosci. 2021 Apr 22;15:660726. doi: 10.3389/fnins.2021.660726. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): October 1, 2019

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): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2020

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 II