Safety and Feasibility of TWIICE Rise - Phase 2
Two-phase Pilot Study on the Safety and Feasibility of TWIICE Rise for Exoskeleton-assisted Ambulation in Patients With Spinal Cord Injury
TWIICE
15 participants
Jul 25, 2023
INTERVENTIONAL
Conditions
Summary
The aim of this study is to assess the safety and the feasibility of two versions of TWIICE Rise for exoskeleton-assisted ambulation in patients with a spinal cord injury. This study is done in two phases: The first phase evaluates the safety and feasibility of TWIICE Rise 0.0 with 5 patients over 6 sessions in clinic. The second phase is being conducted with TWIICE Rise 1.0. This version has potentially improved functionalities based on feedback from Phase 1. Safety and feasibility will be assessed with 10 patients over 10 sessions in different settings (clinic, home, and community environment).
Eligibility
Inclusion Criteria10
- Informed Consent signed by the subject.
- Traumatic and non-traumatic SCI
- Motor incomplete SCI with Neurological Level of Injury (NLI) C5-L5, or Motor Complete SCI with NLI T1-L5 as determined by the ISNCSCI.
- Male and non-pregnant, non-lactating female aged 18 to 70 years old
- At least 6 months after injury
- Able to stand or maintain upright position with a standing device (e.g., 'Easy stand') for at least ten minutes without clinical symptoms of orthostatic hypotension.
- Able to use crutches.
- Able to sit with knees and hips \>= 90° flexion
- Phase 1: Height of 160 to 180 cm, Phase 2: Height of 160 to 190 cm
- Phase 1: Weight of \<80 kg, Phase 2: Weight of \<100 kg
Exclusion Criteria20
- History of severe neurological injuries other than spinal cord injury (e.g., Multiple Sclerosis, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Stroke)
- Ability to walk 10 meters without physical assistance of a person
- Severe concurrent medical disease, illness, or condition
- Systemic or peripheral infection influencing wearing an exoskeleton.
- Diagnosis of coronary artery disease that precludes moderate to intense exercise.
- A medical diagnosis in the patient chart of atherosclerosis, congestive heart failure, or history of myocardial infarction
- Individuals with a pacemaker, defibrillator, drug delivery pump, or other electrical devices if malfunctions could lead to serious adverse events.
- Deep vein thromboses in lower extremities of less than 6 months duration.
- Untreated sever hypertension (systolic blood pressure \>180 mmHg, diastolic blood pressure \>120 mmHg)
- Unstable spine or unhealed limbs
- History of lower extremities or pelvic fragility fractures within the last two years
- Heterotopic ossification that impairs joint mobility
- Significant contractures defined as flexion contracture limited to 20 the hip and knee.
- Severe spasticity (Modified Ashworth grade 4) or uncontrolled clonus
- Diagnosis of severe osteoporosis/penia: Dual Energy X-ray Absorptiometry (DXA) results indicating a t-score below -3.5 at the femoral neck or the total proximal femur bone, and knee bone mineral density (BMD) \< 0.60 gm/cm2
- Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities
- Psychiatric or cognitive conditions that may interfere with the trial.
- Pregnancy or women who plan to become pregnant during the study period, and lactating women.
- Patient is currently involved in any other interventional study.
- Other severe illness that the study physician considers in his/her clinical judgment to be exclusionary.
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Interventions
TWIICE Rise is a lower-limb overground robotic exoskeleton intended for patients with spinal cord injury (SCI). TWIICE Rise is intended to perform ambulatory functions in rehabilitation institutions, home, or community environment under the supervision of a specially trained coach.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07461259