Safety and Feasibility of TWIICE Rise - Phase 2

Official title

Two-phase Pilot Study on the Safety and Feasibility of TWIICE Rise for Exoskeleton-assisted Ambulation in Patients With Spinal Cord Injury

Overview

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).

Detailed description

The aim of this clinical trial 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. The study is thus done in two phases.

The first phase evaluates the safety and feasibility of TWIICE Rise 0.0 with five patients over 6 sessions in clinic. This phase allows the manufacturer to collect data that can be used to improve the device design if necessary.

The second phase of the study is being conducted with TWIICE Rise 1.0. Safety and feasibility will be assessed with 10 patients over 10 sessions in different settings (clinic, home, and community environment) to test the device intended use. The first sessions are done at the rehabilitation specialized center to benefit from the clinical settings to learn to walk with the exoskeleton. Once the patients reach sufficient ambulatory skills determined by the Mobility SkillsTests, the following sessions can be done at home and community settings.

Interventions

• Device TWIICE Rise
  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.

Primary outcome measures

• Incidence of (serious) adverse device effects [Safety] [Time frame: From enrollment to the end of intervention at 10 weeks]
• Incidence of device deficiencies [Safety] [Time frame: From enrollment to the end of intervention at 10 weeks]

Secondary outcome measures (12)

• Incidence of (serious) adverse events [Safety] [Time frame: From enrollment to the end of intervention at 10 weeks]
• Heart rate (pre-training, when standing, and post-training) [Safety] [Time frame: First four session of each participant at three standardized time points: (1) 1 minute before standing, (2) after 1 minute of supported standing in the device (3) within 1 minute after completion of the training session (post-training)]
• Systolic and diastolic blood pressure (pre-training, when standing, and post-training) [Safety] [Time frame: First four session of each participant at three standardized time points: (1) 1 minute before standing, (2) after 1 minute of supported standing in the device (3) within 1 minute after completion of the training session (post-training)]
• Pain rating and location [Safety] [Time frame: From enrollment to the end of intervention at 10 weeks]
• Fatigue rating [Safety] [Time frame: From enrollment to the end of intervention at 10 weeks]
• Skin status rating [Safety] [Time frame: From enrollment to the end of intervention at 10 weeks]
• Number of steps recorded by exoskeleton per training session [Feasibility] [Time frame: Each training session from first session through end of intervention (10 weeks)]
• Training location [Feasibility, phase 2 only] [Time frame: From enrollment to the end of intervention at 10 weeks]
• Type of suface walked on [Feasibility] [Time frame: From enrollment to the end of intervention at 10 weeks]
• 6-Meter Walk Test (6MWT) + Level of Assistance [Feasibility] [Time frame: From enrollment to the end of intervention at 10 weeks]
• 10-Meter Walk Test (10MWT) + Level of Assistance [Feasibility] [Time frame: From enrollment to the end of intervention at 10 weeks]
• Time Up and Go (TUG) + Level of Assistance [Feasibility] [Time frame: From enrollment to the end of intervention at 10 weeks]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

Switzerland · 1 center

• Swiss Paraplegic Centre Nottwil — Nottwil

Identifiers

NCT: NCT07461259 · TWIICE-2021-15-P2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗