Clinical trial NCT05926310: Safety and Feasibility of TWIICE Rise
Official title: Two-phase Pilot Study on the Safety and Feasibility of TWIICE Rise for Exoskeleton-assisted Ambulation in Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Gait Disorders, Neurologic
Keywords: Spinal Cord Injury
Exoskeleton
Robotics
Gait Rehabilitation
Lower-limb
Neurorehabilitation
Paraplegia
Walking
Assistive technology
Usability
Feasibility
Home use
Community use
Lead sponsor: TWIICE
Sponsor class: INDUSTRY
Collaborators: name: Swiss Paraplegic Research, Nottwil
First posted: 2023-07-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 24 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 24 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 a score of 29 in the Mobility SkillsTests, the following sessions can be done at home and community settings.

Eligibility criteria: Inclusion Criteria:

1. Informed Consent signed by the subject.
2. Traumatic and non-traumatic SCI
3. Motor incomplete SCI with Neurological Level of Injury (NLI) C5-L5, or Motor Complete SCI with NLI T1-L5 as determined by the ISNCSCI.
4. Male and non-pregnant, non-lactating female aged 18 to 70 years old
5. At least 6 months after injury
6. 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.
7. Able to use crutches.
8. Able to sit with knees and hips \>= 90° flexion
9. Phase 1: Height of 160 to 180 cm, Phase 2: Height of 160 to 190 cm
10. Phase 1: Weight of \<80 kg, Phase 2: Weight of \<100 kg

Exclusion Criteria:

1. History of severe neurological injuries other than spinal cord injury (e.g., Multiple Sclerosis, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Stroke)
2. Ability to walk 10 meters without physical assistance of a person
3. Severe concurrent medical disease, illness, or condition
4. Systemic or peripheral infection influencing wearing an exoskeleton.
5. Diagnosis of coronary artery disease that precludes moderate to intense exercise.
6. A medical diagnosis in the patient chart of atherosclerosis, congestive heart failure, or history of myocardial infarction
7. Individuals with a pacemaker, defibrillator, drug delivery pump, or other electrical devices if malfunctions could lead to serious adverse events.
8. Deep vein thromboses in lower extremities of less than 6 months duration.
9. Untreated sever hypertension (systolic blood pressure \>180 mmHg, diastolic blood pressure \>120 mmHg)
10. Unstable spine or unhealed limbs
11. History of lower extremities or pelvic fragility fractures within the last two years
12. Heterotopic ossification that impairs joint mobility
13. Significant contractures defined as flexion contracture limited to 20 the hip and knee.
14. Severe spasticity (Modified Ashworth grade 4) or uncontrolled clonus
15. 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
16. Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities
17. Psychiatric or cognitive conditions that may interfere with the trial.
18. Pregnancy or women who plan to become pregnant during the study period, and lactating women.
19. Patient is currently involved in any other interventional study.
20. Other severe illness that the study physician considers in his/her clinical judgment to be exclusionary.

Primary outcomes:
measure: Incidence of (serious) adverse device effects [Safety]
timeFrame: up to 26 weeks
measure: Incidence of device deficiency [Safety]
timeFrame: up to 26 weeks
Secondary outcomes:
measure: Incidence of (serious) adverse events [Safety]
timeFrame: up to 26 weeks
measure: Heart rate (pre-training, when standing, and post-training) [Safety]
timeFrame: up to 10 weeks
measure: Systolic and diastolic blood pressure (pre-training, when standing, and post-training) [Safety]
timeFrame: up to 10 weeks
measure: Pain rating and location [Safety]
timeFrame: up to 26 weeks
measure: Fatigue rating [Safety]
timeFrame: up to 26 weeks
measure: Skin status rating [Safety]
timeFrame: up to 26 weeks
measure: Number of steps taken [Feasibility]
timeFrame: up to 26 weeks
measure: Training location [Feasibility, phase 2 only]
timeFrame: up to 26 weeks
measure: Type of suface walked on [Feasibility]
timeFrame: up to 26 weeks
measure: 6-Meter Walk Test (6MWT) + Level of Assistance [Feasibility]
timeFrame: up to 26 weeks
measure: 10-Meter Walk Test (10MWT) + Level of Assistance [Feasibility]
timeFrame: up to 26 weeks
measure: Time Up and Go (TUG) + Level of Assistance [Feasibility]
timeFrame: up to 26 weeks
measure: Donning and doffing time + Level of Assistance [Feasibility]
timeFrame: up to 26 weeks
measure: Mobility skills test + Level of Assistance [Feasibility]
timeFrame: up to 26 weeks
Other outcomes:
measure: Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) [Satisfaction]
timeFrame: up to 26 weeks
measure: Open-ended questionnaire [Satisfaction]
timeFrame: up to 26 weeks
measure: Subjective health-related questionnaire [General Health]
timeFrame: up to 26 weeks
measure: Psychosocial Impact of Assistive Devices Scales [General Health]
timeFrame: up to 26 weeks
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre Nottwil
state: LU
Study officials:
References: