Self-balancing Personal Exoskeleton for SCI (Site 2)

Официальное название

Empowering Mobility in People With Spinal Cord Injury With a Hands-free, Self-balancing Personal Exoskeleton

Обзор

This study aims to demonstrate the safety and effectiveness of the personal exoskeleton in individuals with spinal cord injury (SCI).

Подробное описание

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.

Вмешательства

• Устройство Hands-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 exoskelet

Первичные конечные точки

• Proportion of subjects who complete the Timed Up and Go (TUG) in 3min or less. [Срок оценки: At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.]
• Proportion of subjects who complete a distance of at least 40m on the Six-Minute Walk Test (6MWT). [Срок оценки: At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.]

Вторичные конечные точки (3)

• 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. [Срок оценки: At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.]
• Proportion of subjects who complete the 10-Meter Walk Test (10MWT) on indoor surfaces in 1 minute or less. [Срок оценки: At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.]
• Proportion of subjects who can don or doff the device within 10 minutes each, separately. [Срок оценки: At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Kessler Foundation — West Orange

Идентификаторы

NCT: NCT06814015 · CIP007 (site 2)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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