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Safety and Feasibility of TWIICE Rise

Primary Purpose

Spinal Cord Injuries, Gait Disorders, Neurologic

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
TWIICE Rise
Sponsored by
TWIICE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Cord Injuries focused on measuring Spinal Cord Injury, Exoskeleton, Robotics, Gait Rehabilitation, Lower-limb, Neurorehabilitation, Paraplegia, Walking, Assistive technology, Usability, Feasibility, Home use, Community use

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Swiss Paraplegic Centre NottwilRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exoskeleton assisted ambulation

Arm Description

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 two times a week for up to 20 weeks for a total of 24 sessions.

Outcomes

Primary Outcome Measures

Incidence of (serious) adverse device effects [Safety]
This outcome is commonly used in healthcare for the measurement of patient safety.
Incidence of device deficiency [Safety]
This outcome is commonly used in healthcare for the measurement of patient safety.

Secondary Outcome Measures

Incidence of (serious) adverse events [Safety]
This outcome is commonly used in healthcare for the measurement of patient safety.
Heart rate (pre-training, when standing, and post-training) [Safety]
Used to assess whether significant changes in essential physiological functions occur following training with TWIICE Rise.
Systolic and diastolic blood pressure (pre-training, when standing, and post-training) [Safety]
Used to assess whether significant changes in essential physiological functions occur following training with TWIICE Rise.
Pain rating and location [Safety]
Used to assess whether training with TWIICE Rise does not cause or exacerbate pain. Pain intensity and location are assessed at the beginning of each session. Pain intensity is evaluated using the Pain Numeric Rating Scale that is a unidimensional measure of pain in adult. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Fatigue rating [Safety]
Used as a measure of exertion due to training with TWIICE Rise. Fatigue is assessed pre-training and post training. The Fatigue Numeric Rating Scale is a patient-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing 'no fatigue' and 10 representing 'as bad as you can imagine'.
Skin status rating [Safety]
Used to assess whether the device's interfaces cause skin lesions. Skin status is rated on a 0 to 4 pressure ulcer scale, 0 representing 'no skin injury' and '4' representing 'very deep wound'.
Number of steps taken [Feasibility]
TWIICE Rise will record the number of steps, walking time, standing time, and walking distance, step frequency, mid-stride pause every session. This information will allow insight into the proportion of time spent training per session.
Training location [Feasibility, phase 2 only]
Used to evaluate the feasibility of using the device in different environments such clinics, home and community settings and the number of sessions in each condition
Type of suface walked on [Feasibility]
This indicated the feasibility of walking on different type of terrain.
6-Meter Walk Test (6MWT) + Level of Assistance [Feasibility]
The distance walked with the powered exoskeleton during the 6MWT. The 6MWT is the primary assessment used to determine the progression of walking skills in exoskeletons.
10-Meter Walk Test (10MWT) + Level of Assistance [Feasibility]
The 10MWT is the best effort time (seconds) it takes the participant to walk a 10 m distance and is recorded while the person performs the 6MWT. This allows assessing the walking speed.
Time Up and Go (TUG) + Level of Assistance [Feasibility]
The TUG test measures the time it takes the participant to stand up from a seated position, walk three meters, turn around, walk back, and sit down again. The TUG test represents the person s ability to use the exoskeletal system since it incorporates multiple aspects of mobility in the device.
Donning and doffing time + Level of Assistance [Feasibility]
Used to evaluate the time needed to install the user inside the device (donning) and back to the wheelchair (doffing). It assesses the feasibility and usability of a device, as the setup time is usually a determining factor for assisting devices.
Mobility skills test + Level of Assistance [Feasibility]
Used to assess the feasibility of the mobility tasks intended with TWIICE Rise. Mobility skills such as standing, walking on different type of ground, and step on a stair are measured separately of each other in an ascending order of difficulty, until two skills cannot be achieved without moderate or maximal assistance.

Full Information

First Posted
June 6, 2023
Last Updated
August 3, 2023
Sponsor
TWIICE
Collaborators
Swiss Paraplegic Research, Nottwil
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1. Study Identification

Unique Protocol Identification Number
NCT05926310
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TWIICE
Collaborators
Swiss Paraplegic Research, Nottwil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exoskeleton assisted ambulation
Arm Type
Experimental
Arm Description
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 two times a week for up to 20 weeks for a total of 24 sessions.
Intervention Type
Device
Intervention Name(s)
TWIICE Rise
Intervention Description
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 Measure Information:
Title
Incidence of (serious) adverse device effects [Safety]
Description
This outcome is commonly used in healthcare for the measurement of patient safety.
Time Frame
up to 26 weeks
Title
Incidence of device deficiency [Safety]
Description
This outcome is commonly used in healthcare for the measurement of patient safety.
Time Frame
up to 26 weeks
Secondary Outcome Measure Information:
Title
Incidence of (serious) adverse events [Safety]
Description
This outcome is commonly used in healthcare for the measurement of patient safety.
Time Frame
up to 26 weeks
Title
Heart rate (pre-training, when standing, and post-training) [Safety]
Description
Used to assess whether significant changes in essential physiological functions occur following training with TWIICE Rise.
Time Frame
up to 10 weeks
Title
Systolic and diastolic blood pressure (pre-training, when standing, and post-training) [Safety]
Description
Used to assess whether significant changes in essential physiological functions occur following training with TWIICE Rise.
Time Frame
up to 10 weeks
Title
Pain rating and location [Safety]
Description
Used to assess whether training with TWIICE Rise does not cause or exacerbate pain. Pain intensity and location are assessed at the beginning of each session. Pain intensity is evaluated using the Pain Numeric Rating Scale that is a unidimensional measure of pain in adult. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Time Frame
up to 26 weeks
Title
Fatigue rating [Safety]
Description
Used as a measure of exertion due to training with TWIICE Rise. Fatigue is assessed pre-training and post training. The Fatigue Numeric Rating Scale is a patient-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing 'no fatigue' and 10 representing 'as bad as you can imagine'.
Time Frame
up to 26 weeks
Title
Skin status rating [Safety]
Description
Used to assess whether the device's interfaces cause skin lesions. Skin status is rated on a 0 to 4 pressure ulcer scale, 0 representing 'no skin injury' and '4' representing 'very deep wound'.
Time Frame
up to 26 weeks
Title
Number of steps taken [Feasibility]
Description
TWIICE Rise will record the number of steps, walking time, standing time, and walking distance, step frequency, mid-stride pause every session. This information will allow insight into the proportion of time spent training per session.
Time Frame
up to 26 weeks
Title
Training location [Feasibility, phase 2 only]
Description
Used to evaluate the feasibility of using the device in different environments such clinics, home and community settings and the number of sessions in each condition
Time Frame
up to 26 weeks
Title
Type of suface walked on [Feasibility]
Description
This indicated the feasibility of walking on different type of terrain.
Time Frame
up to 26 weeks
Title
6-Meter Walk Test (6MWT) + Level of Assistance [Feasibility]
Description
The distance walked with the powered exoskeleton during the 6MWT. The 6MWT is the primary assessment used to determine the progression of walking skills in exoskeletons.
Time Frame
up to 26 weeks
Title
10-Meter Walk Test (10MWT) + Level of Assistance [Feasibility]
Description
The 10MWT is the best effort time (seconds) it takes the participant to walk a 10 m distance and is recorded while the person performs the 6MWT. This allows assessing the walking speed.
Time Frame
up to 26 weeks
Title
Time Up and Go (TUG) + Level of Assistance [Feasibility]
Description
The TUG test measures the time it takes the participant to stand up from a seated position, walk three meters, turn around, walk back, and sit down again. The TUG test represents the person s ability to use the exoskeletal system since it incorporates multiple aspects of mobility in the device.
Time Frame
up to 26 weeks
Title
Donning and doffing time + Level of Assistance [Feasibility]
Description
Used to evaluate the time needed to install the user inside the device (donning) and back to the wheelchair (doffing). It assesses the feasibility and usability of a device, as the setup time is usually a determining factor for assisting devices.
Time Frame
up to 26 weeks
Title
Mobility skills test + Level of Assistance [Feasibility]
Description
Used to assess the feasibility of the mobility tasks intended with TWIICE Rise. Mobility skills such as standing, walking on different type of ground, and step on a stair are measured separately of each other in an ascending order of difficulty, until two skills cannot be achieved without moderate or maximal assistance.
Time Frame
up to 26 weeks
Other Pre-specified Outcome Measures:
Title
Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) [Satisfaction]
Description
Used to measure user satisfaction from participants and therapists. The Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) is designed to measure the level of satisfaction and the value people attribute to assistive technologies. It does so using 12 variables which are scored on a 5 point scale in terms of perceived importance and satisfaction. While items 1-8 rate the satisfaction with the device, items 9-12 are for assessing the satisfaction with the service. If the users are not very satisfied with a feature, they are asked to provide specific feedback. The final score is the mean sum scores of all valid responses with a range of 1 (not satisfied at all) to 5 (very satisfied).
Time Frame
up to 26 weeks
Title
Open-ended questionnaire [Satisfaction]
Description
Used to study design modifications requested by users and clinicians.
Time Frame
up to 26 weeks
Title
Subjective health-related questionnaire [General Health]
Description
4-item questionnaire to assess potential health-related changes due to regular exoskeleton-assisted ambulation, with a 5-point Likert-scale (1 = 'strongly disagree' and 5 = 'strongly agree').
Time Frame
up to 26 weeks
Title
Psychosocial Impact of Assistive Devices Scales [General Health]
Description
The Psychosocial Impact of Assistive Devices Scales (PIADS) is a 26-item (7-point Likert-Scale), self-report questionnaire designed to assess the effects of an assistive device on functional independence, well-being, and quality of life. It is divided into three subscales: Competence, adaptability and self-esteem. For each of the subscales, typically means are calculated that range from -3 (maximum negative impact) to +3 (maximum positive impact). To have only positive sum scores, the range of the individual scores are shifted to 1 to 7, meaning that sum scores range from 1 *26 (26, maximum negative impact) to 7 *26 (182, maximum positive impact). The PIADS is a responsive measure and sensitive to important variables such as the user's clinical condition, device stigma, and functional features of the device. It has been shown to accurately reflect the self-described experiences of people who use assistive devices.
Time Frame
up to 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Widmer, PhD
Phone
+41 41 939 51 97
Email
mario.widmer@paraplegie.ch
Facility Information:
Facility Name
Swiss Paraplegic Centre Nottwil
City
Nottwil
State/Province
LU
ZIP/Postal Code
6207
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Widmer, PhD
Phone
+41 41 939 51 97
Email
mario.widmer@paraplegie.ch

12. IPD Sharing Statement

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Safety and Feasibility of TWIICE Rise

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