Paraplegia and Tetraplegia, Spinal Cord Injury
Conditions
Keywords
Spinal Cord Injury, Robotics, Community use, Hands-free exoskeleton, Overground exoskeleton, Walking, Self-balancing
Brief summary
This study aims to demonstrate the safety and effectiveness of the personal exoskeleton in individuals with spinal cord injury (SCI).
Detailed description
This personal exoskeleton, developed by Wandercraft as a new version of the Atalante X, offers a novel hands-free and self-balancing design, aiming at enhancing stability and mobility for users in daily activities. The study features an interventional, prospective, single-group, and open-label design, conducted over 3 to 4 weeks in a US investigation site. It aims to enroll up to 12 SCI users and their 12 companions, resulting in 12 SCI user-companion pairs. Over the course of nine to ten scheduled visits, participants undergo a sequence of procedures, beginning with screening and device fitting. This is followed by five training sessions which conclude with an evaluation to issue a competency certificate to confirm the ability to use the device across all its "basic skills". Additionally, two sessions are dedicated to evaluating the exoskeleton's effectiveness outcomes, complemented by an extra practice session. Each visit lasts an average of 1.5 hours.
Interventions
DEVICEHands-free exoskeleton
A "device trainer specialist" from the investigation site will deliver training sessions with the exoskeleton to pair of participants (a pair corresponds to an individual with SCI and his/her companion). The device trainer will follow the progression of the pair through the training program and ensure they learn all the device "basic skills". Each training session lasts an average of 1.5 hours, variations according to the user's learning pace and tolerance. During the sessions with the exoskeleton, the participants will engage in mobility activities on different surfaces and perform Activities of Daily Living in simulated environments such as kitchen, bathroom, elevators and outdoor spaces.
Sponsors
Wandercraft
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
Yes
Inclusion criteria
SCI user inclusion Criteria: * Any gender, age 18 years or older; * Motor complete or incomplete SCI with lesions at or above T6; * ≥ 6 months post SCI; * Able and willing to attend 9 to 10 visits1 to the center, including sessions of training and assessments of one-to-three hours duration; * Able to read, understand, and provide informed consent; * Living in the US and speaks English. SCI user
Exclusion criteria
* Diagnosis of neurological injury other than SCI; * Progressive condition that would be expected to result in changing neurological status; * Severe concurrent medical disease, illness or condition judged to be contraindicated by the site physician; * Unhealed or unstable traumatic or high impact lower extremity fracture of any duration that is, in the clinical judgement of the study physician, exclusionary for standing and walking; * Knee (proximal tibia and/or distal femur) BMD \<0.60 gm/cm2; * Total hip BMD T-scores \< -3.5; * Fragility, minimal trauma, or low impact fracture of the lower extremity since SCI; * Untreatable severe spasticity judged to be contraindicated by the site physician; * Untreated/uncontrolled hypertension, as judged to be contraindicated by the site physician; * Unresolved orthostatic hypotension (change from baseline seated BP to a fall in 20mmHg SBP and/or fall in 10mmHG DBP and symptoms when standing), or as judged to be contraindicated by the site physician; * Open or unhealed skin pressure sores, abrasions, or bruises at any of the contact points of the exoskeleton; * Morphological contraindications to the use of the device; * Uncorrectable leg length discrepancy over 2 cm (about 0.79 in) when using additional correction tools; * Unable to effectively operate the device with a hand-control interface, due to functional and/or cognitive impairment, evaluated based on the ability to manipulate the joystick in all direction, press and identify buttons on the hand control interface. * Improper fitting in the device; * Psychopathology documentation in the medical record that may conflict with study objectives; * Pregnancy or women who plan to become pregnant during the study period; * Concurrent participation in another interventional trial; * History of uncontrolled autonomic dysreflexia; * Presence colostomy and/or urostomy; * Ventilator use at the time of the exoskeleton use; Companion inclusion Criteria: * Any gender, age 18 years or older; * Willingness to attend 9 to 10 visits to the center, including sessions of training and assessments of one-to-three hours duration with the SCI user; * Able to read, understand and provide informed consent; * Living in the US and speaks English. Companion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the device for its intended use and user population. | Throughout the study and up until the end of Visit 9, after an average of 9 hours of training and 3 hours of assessment. | Collection and analysis of adverse events to evaluate the safety of the device for its intended use and user population, specifically for individuals with spinal cord injury (SCI) performing ambulatory activities hands-free, accompanied by a companion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects who complete the Timed Up and Go (TUG) in 3min or less. | After a mean of 7.5 hours of training and a mean of 9 hours of training. | The TUG evaluates the time from starting in a seated position to stand-up, walk 3 meters, turn around, walk back 3 meters and sit down on indoor surface. |
| Proportion of subjects who complete a distance of at least 40m on the Six-Minute Walk Test (6MWT). | After a mean of 7.5 hours of training and a mean of 9 hours of training. | The 6MWT measures the distance in meters traversed over 6 min, on indoor surface. |
| Proportion of subjects who can complete at least 4 out of the 6 Activities of Daily Living (ADLs), in various simulated environments and with the exoskeleton. | After a mean of 7.5 hours of training and a mean of 9 hours of training. | The ADLs are done standing in front of the countertop in the kitchen, in a simulated living room, taking a 50m walk in the outdoor environment, taking the elevator, in the bathroom and walking in a hallway and through a door to get to the next room. |
| Proportion of subjects who complete the 10-Meter Walk Test (10MWT) on indoor surfaces in 1 minute or less. | After a mean of 7.5 hours of training and a mean of 9 hours of training. | The 10MWT measures the time in seconds taken to walk 10 meters. |
| Proportion of subjects who can don or doff the device within 10 minutes each, separately. | After a mean of 7.5 hours of training and a mean of 9 hours of training. | — |
Countries
United States
Contacts
CONTACTJoshua Breighner, PT DPT
Outcome results
None listed