Clinical trial NCT04149769: Mobility and Therapeutic Benefits Resulting From Exoskeleton Use in a Home and Community Setting (SC140121 Study 3)
Official title: Mobility and Therapeutic Benefits Resulting From Exoskeleton Use in a Home and Community Setting (SC140121 Study 3)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Poorly-ambulatory subjects previously enrolled in Studies 1 and/or 2, and as such will have prior experience walking in the exoskeleton.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The proposed study is a pilot study intended to inform the hypothesis that regular walking in an exoskeleton within the home and community might offer health benefit, neurological recovery, and/or mobility benefit to the user. This exploratory pilot study is also intended to assess the level of compliance (i.e., exoskeleton use) among study participants by characterizing extent the device is used beyond the minimum required.

Detailed description: Study 3 Outline Study 3 enrollment will be limited to 1 or 2 subjects at each site. Each subject will take home an exoskeleton for the 8-week duration of the treatment period. The subjects will be selected from the pool of poorly-ambulatory subjects previously enrolled in Studies 1 and/or 2, and as such will have prior experience walking in the exoskeleton. Note that study 3 will emply the exoskeleton as per existing FDA approval (510(k) number K171334); specifically, "to enable individuals with spinal cord injury at levels T3 to L5 to perform ambulatory functions \[in the home and community\] with supervision of a specially trained companion in accordance with the user assessment and training certification program." Use of the exoskeleton in the home and community (i.e., outside a clinical setting) is referred to as "personal use." So that this study complies with FDA approval for personal use, subjects selected for enrollment in Study 3, along with each subject's designated support person, will be trained and certified for personal use in accordance with the manufacturer's FDA-approved personal use training program.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older.
* Size and limb proportions capable of fitting in the exoskeletal device :
* Height between 1.55 m (5 ft, 1 in) and 1.92 m (6 ft, 3 in).
* Femur length between 37.5 cm (15 in) and 43.125 cm (17.25 in).
* Body mass no greater than 114 kg (250 lb).
* "Poorly ambulatory" individual, defined as a person with FIM Gait 2- 6, who may be able to walk short distances with or without braces or stability aid, or may be able to walk with assistance of one person, but whose primary means of mobility is a manual or power-operated wheelchair.
* Sufficient upper extremity strength and coordination to balance using appropriate stability aids, such as a rolling walker or forearm crutches, during exoskeleton walking.
* Neurological injury level (NLI) T3 to L5 (between and inclusive).
* Chronic SCI: at least 6 months post-injury, and preferably post-injury more than 1 year.
* Sufficient bone health for walking with full weight-bearing without undue risk of fracture, as determined by each subject's personal medical doctor, and approved by each site's medical supervisor.
* Passive range of motion (PROM) at shoulders, trunk, upper extremities and lower extremities within functional limits for safe gait and use of appropriate assistive device/stability aid.
* Skin intact where interfacing with robotic device.
* MAS for spasticity score 3 or less in lower extremities.
* Resting blood pressure and heart rate within established guidelines for locomotor training, specifically systolic 150 mmHg or less, diastolic 90 mmHg or less, heart rate 105 bpm or less.
* Ability to tolerate an upright standing position for 20 min, passive or active, without being lightheaded or having a headache.
* Availability and willingness of support person to be trained in accordance with the FDA training protocol for personal use of the exoskeleton, and who will assume responsibility for the support person role, which specifically includes providing ambulatory support during all exoskeletal walking.
* Access to a wireless internet connection (for use of exoskeleton iPod device).
* Willingness and ability to electronically send walking session reports from exoskeleton iPod to appointed site monitor following each walking session.

Exclusion Criteria:

* Heterotopic ossification that, in the opinion of the site medical supervisor, would place the subject at undue risk for fracture.
* Inability to follow instructions.
* Colostomy bag.
* Women who are pregnant or attempting to become pregnant during the course of the study. Note that a pregnancy test will be required and must be negative for all women prior to enrolling in the study, and will be additionally required and must be negative every four weeks during the course of the study protocol.
* Any disease, concomitant injury, or condition that interferes with the performance or interpretation of the protocol- specified assessments.
* Insufficient availability to complete study.
* Any other issue which, in the opinion of the investigators or medical supervisor, make the subject unsuitable for study participation.

Primary outcomes:
measure: Ten meter walk test (10MWT)
timeFrame: 18 weeks
measure: Six minute walk test (6MWT)
timeFrame: 18 weeks
measure: Walking Index for Spinal Cord Injury II (WISCI-II)
timeFrame: 18 weeks
measure: Functional Independence Measures (FIM) gait score
timeFrame: 18 weeks
Secondary outcomes:
measure: Timed Up and Go Test (TUG)
timeFrame: 18 weeks
measure: Borg Rating Scale of Perceived Exertion (RPE)
timeFrame: 18 weeks
measure: Modified Ashworth Score (MAS)
timeFrame: 18 weeks
measure: Bone Mineral Density
timeFrame: 18 weeks
measure: Functional Reach
timeFrame: 18 weeks
measure: Manual Muscle Test (MMT)
timeFrame: 18 weeks
measure: Ten Meter Walk Test without exoskeleton (10MWT)
timeFrame: 18 weeks
measure: Functional Independence Measures (FIM) gait score without exoskeleton
timeFrame: 18 weeks
measure: Walking Index for Spinal Cord Injury II (WISCI-II) score without exoskeleton
timeFrame: 18 weeks
Other outcomes:
measure: Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET)
timeFrame: 18 weeks
measure: Self-Report Survey
timeFrame: 18 weeks
measure: American Spinal Injury Association (ASIA) Impairment Scale
timeFrame: 18 weeks
Locations:
city: Tampa
country: United States
facility: Tampa VA
state: Florida
city: Rochester
country: United States
facility: Minnesota Mayo Clinic
state: Minnesota
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Michael Goldfarb, PhD
role: PRINCIPAL_INVESTIGATOR
References: