Exoskeleton for post-stroke recovery of ambulation (ExStRA): study protocol for a mixed-methods study investigating the efficacy and acceptance of an exoskeleton-based physical therapy program during stroke inpatient rehabilitation

Louie, Dennis R.; Durocher, Melanie; Teasell, Robert; Yao, Jennifer; Eng, Janice J.

doi:10.1186/s12883-020-1617-7

Cited by 42 publications

(20 citation statements)

References 50 publications

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“…To date only one study by Read et al,(2020) specifically investigated perspectives of 3 PTs on exoskeleton use using semi-structured interviews with persons with SCI or stroke. Currently, a mixed-methods study is underway to investigate perspectives of PTs and persons with stroke [ 26 ]. Thus, further research is needed to explore in-depth, utilizing a qualitative research approach, end-users’ perspectives on lower limb exoskeleton use in post-stroke gait rehabilitation.…”

Section: Introductionmentioning

confidence: 99%

Exoskeleton use in post-stroke gait rehabilitation: a qualitative study of the perspectives of persons post-stroke and physiotherapists

Vaughan-Graham

Brooks

Rose

et al. 2020

J NeuroEngineering Rehabil

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Background Wearable powered exoskeletons are a new and emerging technology developed to provide sensory-guided motorized lower limb assistance enabling intensive task specific locomotor training utilizing typical lower limb movement patterns for persons with gait impairments. To ensure that devices meet end-user needs it is important to understand and incorporate end-users perspectives, however research in this area is extremely limited in the post-stroke population. The purpose of this study was to explore in-depth, end-users perspectives, persons with stroke and physiotherapists, following a single-use session with a H2 exoskeleton. Methods We used a qualitative interpretive description approach utilizing semi-structured face to face interviews, with persons post-stroke and physiotherapists, following a 1.5 h session with a H2 exoskeleton. Results Five persons post-stroke and 6 physiotherapists volunteered to participate in the study. Both participant groups provided insightful comments on their experience with the exoskeleton. Four themes were developed from the persons with stroke participant data: (1) Adopting technology; (2) Device concerns; (3) Developing walking ability; and, (4) Integrating exoskeleton use. Five themes were developed from the physiotherapist participant data: (1) Developer-user collaboration; (2) Device specific concerns; (3) Device programming; (4) Patient characteristics requiring consideration; and, (5) Indications for use. Conclusions This study provides an interpretive understanding of end-users perspectives, persons with stroke and neurological physiotherapists, following a single-use experience with a H2 exoskeleton. The findings from both stakeholder groups overlap such that four over-arching concepts were identified including: (i) Stakeholder participation; (ii) Augmentation vs. autonomous robot; (iii) Exoskeleton usability; and (iv) Device specific concerns. The end users provided valuable perspectives on the use and design of the H2 exoskeleton, identifying needs specific to post-stroke gait rehabilitation, the need for a robust evidence base, whilst also highlighting that there is significant interest in this technology throughout the continuum of stroke rehabilitation.

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Section: Introductionmentioning

confidence: 99%

Exoskeleton use in post-stroke gait rehabilitation: a qualitative study of the perspectives of persons post-stroke and physiotherapists

Vaughan-Graham

Brooks

Rose

et al. 2020

J NeuroEngineering Rehabil

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“…The full protocol and design of this multicenter, parallel-group, randomized controlled trial have been described elsewhere [ 24 ]. Approval was granted by each respective local research ethics board and operational institute to conduct the study in Vancouver, Edmonton, and London, Canada.…”

Section: Methodsmentioning

confidence: 99%

“…However, they were instructed to continue focusing on gait training for 75% of their weekly physical therapy sessions if the exoskeleton was discontinued. Guidelines for adapting and progressing gait training using the exoskeleton device, suggested training duration and step count targets (≥ 25 min of walking and ≥ 700 steps per session by the fourth week of exoskeletal gait training), as well as an algorithm to assist decision-making to discontinue use of the exoskeleton, were provided to intervention therapists [ 24 ]. The remaining 25% of weekly physical therapy sessions allowed the therapists to work on other goals of their choice (e.g., discharge planning, upper extremity, pain management).…”

Section: Methodsmentioning

confidence: 99%

Efficacy of an exoskeleton-based physical therapy program for non-ambulatory patients during subacute stroke rehabilitation: a randomized controlled trial

Louie

Durocher

Schneeberg

et al. 2021

J NeuroEngineering Rehabil

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Background Individuals requiring greater physical assistance to practice walking complete fewer steps in physical therapy during subacute stroke rehabilitation. Powered exoskeletons have been developed to allow repetitious overground gait training for individuals with lower limb weakness. The objective of this study was to determine the efficacy of exoskeleton-based physical therapy training during subacute rehabilitation for walking recovery in non-ambulatory patients with stroke. Methods An assessor-blinded randomized controlled trial was conducted at 3 inpatient rehabilitation hospitals. Patients with subacute stroke (< 3 months) who were unable to walk without substantial assistance (Functional Ambulation Category rating of 0 or 1) were randomly assigned to receive exoskeleton-based or standard physical therapy during rehabilitation, until discharge or a maximum of 8 weeks. The experimental protocol replaced 75% of standard physical therapy sessions with individualized exoskeleton-based sessions to increase standing and stepping repetition, with the possibility of weaning off the device. The primary outcome was walking ability, measured using the Functional Ambulation Category. Secondary outcomes were gait speed, distance walked on the 6-Minute Walk Test, days to achieve unassisted gait, lower extremity motor function (Fugl-Meyer Assessment), Berg Balance Scale, Patient Health Questionnaire, Montreal Cognitive Assessment, and 36-Item Short Form Survey, measured post-intervention and after 6 months. Results Thirty-six patients with stroke (mean 39 days post-stroke) were randomized (Exoskeleton = 19, Usual Care = 17). On intention-to-treat analysis, no significant between-group differences were found in the primary or secondary outcomes at post-intervention or after 6 months. Five participants randomized to the Exoskeleton group did not receive the protocol as planned and thus exploratory as-treated and per-protocol analyses were undertaken. The as-treated analysis found that those adhering to exoskeleton-based physical therapy regained independent walking earlier (p = 0.03) and had greater gait speed (p = 0.04) and 6MWT (p = 0.03) at 6 months; however, these differences were not significant in the per-protocol analysis. No serious adverse events were reported. Conclusions This study found that exoskeleton-based physical therapy does not result in greater improvements in walking independence than standard care but can be safely administered at no detriment to patient outcomes. Clinical Trial Registration The Exoskeleton for post-Stroke Recovery of Ambulation (ExStRA) trial was registered at ClinicalTrials.gov (NCT02995265, first registered: December 16, 2016)

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“…While individual comorbidities may not directly affect outcomes observed in the use of exoskeleton, chronic conditions such as pressure sores, spinal instability, deep vein thrombosis, uncontrolled hypertension, among others (Palermo et al, 2017) are direct contraindications for the use of the device; hence limiting the pool of patients that can be included in the research studies. Well-controlled randomized trials on exoskeleton rehabilitation are emerging as per published protocols (Louie et al, 2020). We recognize that the follow up of the patients beyond their discharge from the rehabilitation hospital was not done.…”

Section: Study Limitationsmentioning

confidence: 99%

Predictors of Functional Outcome in a Cohort of Hispanic Patients Using Exoskeleton Rehabilitation for Cerebrovascular Accidents and Traumatic Brain Injury

et al. 2021

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Traumatic brain injury (TBI) and cerebrovascular accidents (CVA) are two of the leading causes of disability in the United States. Robotic exoskeletons (RE) have been approved for rehabilitation by the Federal Drug Administration (FDA) for use after a CVA, and recently received approval for use in patients with TBI. The aim of the study was to determine which factors predict the improvement in functional independence measure (FIM) score after using RE rehabilitation in a population of patients with CVA or TBI. We carried out a retrospective chart-review analysis of the use of the RE (Ekso® GT) in the rehabilitation of patients with TBI and CVA using data from a single, private rehabilitation hospital for patients admitted and discharged between 01/01/2017 and 04/30/2020. From the medical records, we collected presentation date, Glasgow Coma Scale score (GCS) on the date of injury, rehabilitation start date, age, diabetes status on presentation (Yes or No), injury category (TBI or CVA), and both admission and discharge FIM scores. Matching algorithms resulted in one TBI patient matched to three CVA patients resulting in a sample size of 36. The diabetic and non-diabetic populations showed significant differences between age and days from injury to the start of rehabilitation. A multivariate linear regression assessed predictors for discharge motor FIM and found admission motor FIM score and total RE steps to be statistically significant predictors. For each point scored higher on the admission motor FIM the discharge FIM was increased by 1.19 FIM points, and for each 1,000 steps taken in the RE, the discharge motor FIM increased by three points. The type of acquired brain injury (CVA or TBI) was not found to affect functional outcome. The presented results show that key clinic-biologic factors including diabetic status, together with start to rehabilitation play key roles in discharge FIM scores for patients using RE.Clinical Trial Registration: ClinicalTrials.gov, NCT04465019

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Exoskeleton for post-stroke recovery of ambulation (ExStRA): study protocol for a mixed-methods study investigating the efficacy and acceptance of an exoskeleton-based physical therapy program during stroke inpatient rehabilitation

Cited by 42 publications

References 50 publications

Exoskeleton use in post-stroke gait rehabilitation: a qualitative study of the perspectives of persons post-stroke and physiotherapists

Exoskeleton use in post-stroke gait rehabilitation: a qualitative study of the perspectives of persons post-stroke and physiotherapists

Efficacy of an exoskeleton-based physical therapy program for non-ambulatory patients during subacute stroke rehabilitation: a randomized controlled trial

Predictors of Functional Outcome in a Cohort of Hispanic Patients Using Exoskeleton Rehabilitation for Cerebrovascular Accidents and Traumatic Brain Injury

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