Two-phase Pilot Study on the Safety and Feasibility of TWIICE Rise for Exoskeleton-assisted Ambulation in Patients With Spinal Cord Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- TWIICE
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Incidence of (serious) adverse device effects [Safety]
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Exoskeleton assisted ambulation
Phase 1: Five participants will undergo a training programme with the TWIICE Rise 0.0 two times a week for up to 6 weeks for a total of 6 sessions.
Phase 2: Ten participants will undergo a training programme with the TWIICE Rise 1.0 2-3 times a week for up to 10 weeks for a total of 10 sessions.
Intervention: TWIICE Rise (Device)
Outcomes
Primary Outcomes
Incidence of (serious) adverse device effects [Safety]
Time Frame: From enrollment to the end of intervention at 10 weeks
This outcome is commonly used in healthcare for the measurement of patient safety.
Incidence of device deficiencies [Safety]
Time Frame: From enrollment to the end of intervention at 10 weeks
Device deficiencies will be assessed according to ISO 14155 (any inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance). All device deficiencies will be prospectively recorded by study personnel in the Case Report Form at each device-use session and via interim reports throughout the 10-week intervention. Incidence is defined as the number of new device deficiencies occurring during the study period per participant and per device-use session
Secondary Outcomes
- Incidence of (serious) adverse events [Safety](From enrollment to the end of intervention at 10 weeks)
- Heart rate (pre-training, when standing, and post-training) [Safety](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](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](From enrollment to the end of intervention at 10 weeks)
- Fatigue rating [Safety](From enrollment to the end of intervention at 10 weeks)
- Skin status rating [Safety](From enrollment to the end of intervention at 10 weeks)
- Number of steps recorded by exoskeleton per training session [Feasibility](Each training session from first session through end of intervention (10 weeks))
- Training location [Feasibility, phase 2 only](From enrollment to the end of intervention at 10 weeks)
- Type of suface walked on [Feasibility](From enrollment to the end of intervention at 10 weeks)
- 6-Meter Walk Test (6MWT) + Level of Assistance [Feasibility](From enrollment to the end of intervention at 10 weeks)
- 10-Meter Walk Test (10MWT) + Level of Assistance [Feasibility](From enrollment to the end of intervention at 10 weeks)
- Time Up and Go (TUG) + Level of Assistance [Feasibility](From enrollment to the end of intervention at 10 weeks)
- Donning and doffing time + Level of Assistance [Feasibility](From enrollment to the end of intervention at 10 weeks)
- Mobility skills test + Level of Assistance [Feasibility](up to 16 weeks)
- Slope inclination(From enrollment to the end of intervention at 10 weeks)
- Walking speed recorded by exoskeleton during training sessions [Feasibility](Each training session from first session through end of intervention (10 weeks))
- Time spent in exoskeleton activity modes per training session [Feasibility](Each training session from first session through end of intervention (10 weeks))