Clinical trial NCT06777576: Self-balancing Personal Exoskeleton for SCI
Official title: Empowering Mobility in People With Spinal Cord Injury With a Hands-free, Self-balancing Personal Exoskeleton
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries (SCI)
Paraplegia and Tetraplegia
Keywords: Spinal Cord Injury
Robotics
Community use
Hands-free exoskeleton
Overground exoskeleton
Walking
Self-balancing
Lead sponsor: Wandercraft
Sponsor class: INDUSTRY
Collaborators: name: James J. Peters Veterans Affairs Medical Center
First posted: 2025-01-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 at two US research facilities. 24 subjects are required to complete the study. Anticipating a 15% dropout rate, the study will enroll 29 participants.

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.

Eligibility 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;
* Insufficient strength and performance capability (the ability to transfer into/out of the device or perform other training tasks with assistance).

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 exclusion Criteria:

* Inability to communicate with an assistant due to cognitive and language disorders;
* Any disease, concomitant injury, or condition that interferes with the performance or interpretation of the protocol- specified assessments;
* Insufficient strength and performance capability, evidenced by the ability to hold and retain the device in case of unbalance/fall;
* Insufficient availability to complete the study;
* Concurrent participation in another interventional trial.

Primary outcomes:
measure: Proportion of subjects who complete the Timed Up and Go (TUG) in 3min or less.
timeFrame: At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.
measure: Proportion of subjects who complete a distance of at least 40m on the Six-Minute Walk Test (6MWT).
timeFrame: At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.
Secondary outcomes:
measure: 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.
timeFrame: At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.
measure: Proportion of subjects who complete the 10-Meter Walk Test (10MWT) on indoor surfaces in 1 minute or less.
timeFrame: At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.
measure: Proportion of subjects who can don or doff the device within 10 minutes each, separately.
timeFrame: At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.
Other outcomes:
measure: Proportion of users who pass the device "basic skills" certification evaluation at the end of visit 6.
timeFrame: Throughout the study and up until the end of Visit 6, after an average of 7.5 hours of training.
measure: Number of users who successfully master the different basic skills at a given visit
timeFrame: Throughout the study and up until the end of Visit 6, after an average of 7.5 hours of training.
measure: Evaluation of the assistance level provided by companion.
timeFrame: Throughout the study and up until the end of Visit 9, after an average of 9 hours of training and 3 hours of assessment.
measure: Overall Rating of Perceived Exertion (RPE) assessed with the Borg RPE scale by the users for the entire session.
timeFrame: At the end of visit 6 after an average of 7.5 hours of training, at the end of visit 7 after an average of 7.5 hours of training and 1.5 hours of assessment and at the end of visit 9, after an average of 9 hours of training and 3 hours of assessment.
measure: Overall perceived safety with a 7-level Likert scale by the users on the entire session.
timeFrame: At the end of visit 6 after an average of 7.5 hours of training, at the end of visit 7 after an average of 7.5 hours of training and 1.5 hours of assessment and at the end of visit 9, after an average of 9 hours of training and 3 hours of assessment.
measure: Up-right time in the device at each session
timeFrame: Throughout the study and up until the end of Visit 9, after an average of 9 hours of training and 3 hours of assessment.
measure: Numbers of steps taken in the device at each session
timeFrame: Throughout the study and up until the end of Visit 9, after an average of 9 hours of training and 3 hours of assessment.
measure: Distance walked in the device at each session
timeFrame: Throughout the study and up until the end of Visit 9, after an average of 9 hours of training and 3 hours of assessment.
measure: Number of times the participants walk on each type of surface at each session
timeFrame: Throughout the study and up until the end of Visit 9, after an average of 9 hours of training and 3 hours of assessment.
measure: Perceived health benefits and overall satisfaction and motivation.
timeFrame: At visit 9, after an average of 9 hours of training and 3 hours of assessment.
Locations:
city: Bronx
country: United States
facility: James J. Peters, VA Medical Center, Bronx, NY
state: New York
Study officials:
References: