Cerebrovascular Accident, Hemiparesis, Hemiplegia, Stroke, Stroke, Acute, Stroke Hemorrhagic
Conditions
Keywords
Stroke, Exoskeleton, Hemiparesis, Hemiplegia
Brief summary
A multi-site, interventional, non-comparative, single-arm trial to evaluate the safety of the ReWalk ReStore device in subjects with hemiplegia/hemiparesis due to ischemic or hemorrhagic stroke.
Interventions
DEVICEReWalk ReStore device
The ReWalk ReStore device is intended to be used to perform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia/hemiparesis due to stroke.
Sponsors
Shirley Ryan AbilityLab
Kessler Foundation
TIRR Memorial Hermann
Spaulding Rehabilitation Hospital
Moss Rehabilitation Research Institute
ReWalk Robotics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of one-sided ischemic or hemorrhagic stroke (\>2 weeks post stroke) * Presentation of hemiparesis/hemiplegia resulting from stroke * At least 18 years of age * Height of 4'8 - 6'7 * Weight of less than 264 lbs * Medical clearance by a clinician treating the subject * Able to ambulate at least 5 feet without an ankle foot orthosis (AFO), with no more than minimal contact assistance from a PT * Able to follow a 3-step command * Able to fit suit components (waistbelt, calf wrap) * No greater than 5 degrees of plantar flexion contracture during passive ankle ROM * Modified Ashworth Scale for spasticity at 3 or less for ankle dorsi-flexors and plantar-flexors
Exclusion criteria
* Severe aphasia limiting ability to express needs or discomfort verbally or non-verbally * Serious co-morbidities that, in the opinion of the investigator, may interfere with ability to participate * History of significant Peripheral Artery Disease * Colostomy bag * Current pregnancy * Uncontrolled or untreated hypertension * Currently participating in any other ongoing clinical trial * Presence of open wounds or broken skin at device locations requiring medical management * Known urethane allergies * Current medical diagnosis of DVT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of device-related adverse events [Safety] | duration of study participation for each subject, estimated 4 weeks | Safety will be evaluated on the basis of the number of device-related adverse events reported for subjects during their participation in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of device malfunctions during study procedures [Device Reliability] | duration of study completion for each site, estimated 4 months | Device reliability will be evaluated on the basis of the number of device malfunctions reported by research study staff for the duration of study procedures at each study site. |
| Incidence of injury to physical therapist caused by device [PT safety] | duration of study completion for each site, estimated 4 months | PT safety will be evaluated on the basis of the number of device-related injuries reported by study physical therapists for the duration of study procedures at each study site. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Modified QUEST questionnaire [subject satisfaction] | duration of study participation for each subject, estimated 4 weeks | Subjects will complete a modified QUEST questionnaire (Quebec User Evaluation of Assistive Technology) to indicate their level of satisfaction with the ReStore device (on a scale from 1 to 5) in 8 different categories. |
| Gait speed measured with 10 Meter Walk Test | duration of study participation for each subject, estimated 4 weeks | Subjects will perform a 10 Meter Walk Test to evaluate walking speed with and without the ReStore device. |
| Physical Therapist satisfaction questionnaire [PT satisfaction] | duration of study completion for each site, estimated 4 months | Physical Therapists involved in the study will complete a PT satisfaction questionnaire at the end of the study to indicate their level of satisfaction (on a scale from 1 to 5) with the ReStore device in 9 different categories. |
| Gait analysis using a gait mat | duration of study participation for each subject, estimated 4 weeks | Subjects will walk across a gait mat device (such as GAITRite) which records step timing and step placement in order to evaluate their walking with and without the ReStore device. |
| Walking distance measured with 2 Minute Walk Test | duration of study participation for each subject, estimated 4 weeks | Subjects will perform a 2 Minute Walk Test (2MWT) to evaluate the 2 minute walking distance with the ReStore device in Slack, Assist, and Brace modes |
Countries
United States
Outcome results
None listed