Clinical trial NCT02545205: New Technology for Individualised, Intensive Training of Gait After Stroke Study I
Official title: New Technology for Individualised, Intensive Training of Gait After Stroke- Phase II Trials, Study I
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Ambulation Difficulty
Hemiparesis
Keywords: Rehabilitation
Robotics
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: University of Tsukuba
name: Sahlgrenska University Hospital
name: Umeå University
First posted: 2015-09-09
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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?

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Functional Ambulation Categories (FAC)
timeFrame: Assessed at baseline, weekly, after 4 weeks of intervention and at 6 months post intervention
Secondary outcomes:
measure: Objectively quantify the impairment caused by a stroke, using the National Institutes of Health Stroke Scale (NIHSS)
timeFrame: At baseline
measure: Fugl-Meyer for Lower extremities
timeFrame: Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention
measure: Albert's test
timeFrame: Assessed at baseline
measure: 2 Minutes Walk Test (MWT)
timeFrame: Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention
measure: Berg Balance scale
timeFrame: Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention
measure: Barthel Index
timeFrame: Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention
measure: Perception of the intervention
timeFrame: after 4 weeks of intervention
measure: Stroke Impact Scale (SIS)
timeFrame: Assessed at 6 months after intervention
measure: EQ-5D
timeFrame: Assessed at baseline, after 4 weeks of intervention and at 6 months post intervention
Other outcomes:
Locations:
city: Danderyd
country: Sweden
facility: Department of Rehabilitation Medicine, Danderyd Hospital
state: Stockholm
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
References:
citation: 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.
citation: 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.