Assessment of Safety and Acute Effects of a Knee-hip Powered Soft Exoskeleton in Patients With Neuromuscular Disorders (Exo-NMD1)
Primary Purpose
Muscular Dystrophies, Congenital Myopathy, Idiopathic Inflammatory Myopathies
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Knee-hip Powered Soft Exoskeleton (MyoSuit, MyoSwiss, Zurich, Switzerland)
Sponsored by
About this trial
This is an interventional other trial for Muscular Dystrophies focused on measuring Neuromuscular disorders, Myopathy, Muscle, Exoskeleton, Device, Motion assistance, FSHD, LGMD
Eligibility Criteria
Inclusion Criteria:
- 18 years and < 70 years of age
- Height between 1.50 m and 1.95 m
- Weight between 45 kg and 110 kg
- Abdominal perimeter < 125 cm
- Written informed consent
- Affiliate or beneficiary of a social security scheme
- Able to comply with all protocol requirements
Confirmed diagnosis of a pathology belonging to one of the following family*:
Primary disorders of muscles
- Muscular dystrophy
- Congenital myopathies
- Idiopathic inflammatory myopathy
- Mitochondrial myopathies
Metabolic disorders
- Inborn errors of metabolism
- Glycogen storage disease
Functional capacities:
- Able to stand up from a chair with armrest without other supports at least 3 times and at most 15 times in 30 seconds.
- Report the ability to walk without the assistance of a person at least 2min
- The use of traditional orthoses and walking aids will be accepted excepted knee orthoses and walkers (e.g. canes/crutches, ankle foot orthosis).
Exclusion Criteria:
- Unable to participate in the study
- Inability to comply with protocol requirements
- Guardianship/trusteeship
- Pregnant or nursing women
- Unstable Cardiomyopathy
- Symptomatic orthostatic hypotension
- Medical history of osteoporotic fracture
- Balance disorder with extra neuromuscular causes
- Recent trauma (fall, accident, ...)
- Unstable Cardiomyopathy
- Severe respiratory insufficiency
- Flexion contracture in the knee and hip joint in excess of 10°
- Varus malposition in excess of 10° or valgus malposition in excess of 10°
Sites / Locations
- Institute of MyologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Knee-hip Powered Soft Exoskeleton
No assistance device
Arm Description
Patients and healthy subjects will use a Knee-hip Powered Soft Exoskeleton to perform different standardised tasks
Patients and healthy subjects will perform different standardised tasks without Knee-hip Powered Soft Exoskeleton
Outcomes
Primary Outcome Measures
Absence of adverse effect attributable to the use of the device during task performed within a knee-hip powered soft exoskeleton
Secondary Outcome Measures
Variation in the 2 Minutes Walking Test distance (express in meters) when performed using versus not using the device
Variation in the 10 Meters Walking Test performance (express in seconds) when performed using versus not using the device
Difference of performance with and without the device during 30 Sit To Stand
Difference of performance with and without the device during simple Sit To Stand
Difference of performance with and without the device during the squating test
Difference of performance with and without the device during Time Up & Go test
Difference of performance with and without the device during stairs climbing test
Variation in spatiotemporal gait parameters during the 2 Minutes Walking Test with and without the device using 3D accelerometers' system
Spatiotemporal gait parameters: Cadence, Gait Speed, Step Duration, Stride Length, Cadence Asymmetry, Gait Speed Asymmetry, Stance Asymmetry, Stride Length Asymmetry
Variation in spatiotemporal gait parameters during the 10 Meters Walking Test with and without the device using 3D accelerometers' system
Spatiotemporal gait parameters: Cadence, Gait Speed, Step Duration, Stride Length, Cadence Asymmetry, Gait Speed Asymmetry, Stance Asymmetry, Stride Length Asymmetry
Variation in kinematics parameters during 30 Sit To Stand with and without the device using 3D accelerometers' system
Kinematics parameters: Gait Joint Angles, Stick Plot Visualization - Sagital plane, Hip-Knee & Knee-Ankle Plots
Variation in kinematics parameters during unique Sit To Stand with and without the device using 3D accelerometers' system
Kinematics parameters: Gait Joint Angles, Stick Plot Visualization - Sagital plane, Hip-Knee & Knee-Ankle Plots
Variation in kinematics parameters during Time Up & Go evaluation with and without the device using 3D accelerometers' system
Kinematics parameters: Gait Joint Angles, Stick Plot Visualization - Sagital plane, Hip-Knee & Knee-Ankle Plots
Variation in kinematics parameters during stairs climbing test with and without the device using 3D accelerometers' system
Kinematics parameters: Gait Joint Angles, Stick Plot Visualization - Sagital plane, Hip-Knee & Knee-Ankle Plots
Modification of lower limb muscle recruitment measured by surface EMG with and without the device
Variation in postural stability measured by force platform with and without the device
Mean Velocity, RMS Sway
Modification in scoring of the device measured by the Modified Nordic Questionnaire
Positive scoring of device efficiency measured by the System usability scale
Full Information
NCT ID
NCT05200702
First Posted
December 2, 2021
Last Updated
September 26, 2023
Sponsor
Institut de Myologie, France
1. Study Identification
Unique Protocol Identification Number
NCT05200702
Brief Title
Assessment of Safety and Acute Effects of a Knee-hip Powered Soft Exoskeleton in Patients With Neuromuscular Disorders
Acronym
Exo-NMD1
Official Title
Assessment of Safety and Acute Effects of a Knee-hip Powered Soft Exoskeleton in Patients With Neuromuscular Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Myologie, France
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 aims of the current study are as follow:
i) Evaluate the safety, usability, and acute efficiency of a powered knee-hip dermoskeleton (MyoSuit, MyoSwiss, Zurich, Switzerland) in patients with neuromuscular disorders, ii) Elaborate recommendations regarding usability criteria for safe and efficient use the device in patients with neuromuscular disorders (e.g. type and severity of patient's functional deficits), iii) generate necessary data to foresee a future study involving a home use of the device and assessment of long-term benefits.
Detailed Description
Patients with neuromuscular disorders display different type of symptoms depending on the type of pathology. Diseases like facioscapulohumeral dystrophy (FSHD), limb-girdle muscular dystrophy (LGMD2b), sporadic inclusion body myositis (SIBM) or Pompe disease (PD) are characterized by severe muscle weakness leading to reduced functional capacities. This leads to a dramatic decrease of quality of life (e.g. reduced autonomy/participation, social isolation, depression) associated with increased fall risk and complications (e.g. trauma, cardio-vascular issues, trauma, chronic pain, loss of bone mass, and weight gain).
However, a residual of level of strength and residual function may be maintained over years, even at severe disease stages allowing transfers and ambulation. However, the maintenance of this type of activity is often associated with substantial compensatory movements, leading to high load on joints, orthopedic complications, and high fall-risk.
In contrast to traditional passive assistive devices such as orthoses, powered assistive devices, frequently termed dermo- or exoskeletons, have a very high potential for compensating muscle weakness and regain mobility and independence. Devices such as the ReWalk or the Indego use rigid structures, in parallel to the user's legs, and electric motors to stabilize the human against gravity during standing and walking. Thus far, these systems have been used mostly in clinical environments for gait rehabilitation in neurological conditions (e.g. spinal cord injury, post-stroke syndrome). Their weight, which can range from 13 to 48 kg , can make them difficult to use and transport, thus limiting their applicability beyond clinical environments. However, for assistive devices to be used in everyday life, they must provide assistance across activities of daily living (ADLs) in an unobtrusive manner.
Wearable motion assistance systems, especially those dedicated to lower limbs are highly promising for ambulant patients with neuromuscular disorders (e.g. FSHD, LGMD, SIBM or PD). In these conditions, the prevalence of lower-limb muscle weakness, in particular in proximal muscle groups (i.e. providing strength/torque to hips and knees) is very high. Schmidt et al. recently introduced a powered knee-hip soft exoskeleton (the Myosuit), a soft, wearable device designed to provide continuous assistance at the hip and knee joint when working with and against gravity in ADLs. This robotic device combines active and passive elements with a closed-loop force controller designed to behave like an external muscle (exomuscle) and deliver gravity compensation to the user. With 5.6 kg including batteries, the Myosuit is one of the lightest untethered devices capable of delivering gravity support to the user's knee and hip joints. In healthy subject, the Myosuit has been shown to effectively assist its users in gravity-intensive ADLs, such as sitting transfers. However, the effect of the device on movement parameters and user perception must be clarified. We believe that ambulant patients with neuromuscular disorders can highly benefit from a system that provides mobility assistance like the Myosuit. The use of such a device has the potential to shift the loss of ambulation/transfer abilities to a higher age and might mitigate disease progression and occurrence of complications. Whether the Myosuit may be safe, usable, and efficient in ambulant patients with neuromuscular disorders, remain to be specifically investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Dystrophies, Congenital Myopathy, Idiopathic Inflammatory Myopathies, Mitochondrial Myopathies, Glycogen Storage Disease
Keywords
Neuromuscular disorders, Myopathy, Muscle, Exoskeleton, Device, Motion assistance, FSHD, LGMD
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparison of the results obtained during different standardized physical evaluations by patients and healthy subjects, with or without a movement assistance device.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Knee-hip Powered Soft Exoskeleton
Arm Type
Experimental
Arm Description
Patients and healthy subjects will use a Knee-hip Powered Soft Exoskeleton to perform different standardised tasks
Arm Title
No assistance device
Arm Type
No Intervention
Arm Description
Patients and healthy subjects will perform different standardised tasks without Knee-hip Powered Soft Exoskeleton
Intervention Type
Device
Intervention Name(s)
Knee-hip Powered Soft Exoskeleton (MyoSuit, MyoSwiss, Zurich, Switzerland)
Intervention Description
Patients and healthy subjects will wear the movement assistance device to perform different standardised physical evaluations.
Primary Outcome Measure Information:
Title
Absence of adverse effect attributable to the use of the device during task performed within a knee-hip powered soft exoskeleton
Time Frame
Through study completion, on average 4 weeks
Secondary Outcome Measure Information:
Title
Variation in the 2 Minutes Walking Test distance (express in meters) when performed using versus not using the device
Time Frame
Visit 2 and 3, on average 2 weeks
Title
Variation in the 10 Meters Walking Test performance (express in seconds) when performed using versus not using the device
Time Frame
Visit 2 and 3, on average 2 weeks
Title
Difference of performance with and without the device during 30 Sit To Stand
Time Frame
Visit 2 and 3, on average 2 weeks
Title
Difference of performance with and without the device during simple Sit To Stand
Time Frame
Visit 2 and 3, on average 2 weeks
Title
Difference of performance with and without the device during the squating test
Time Frame
Visit 2 and 3, on average 2 weeks
Title
Difference of performance with and without the device during Time Up & Go test
Time Frame
Visit 2 and 3, on average 2 weeks
Title
Difference of performance with and without the device during stairs climbing test
Time Frame
Visit 2 and 3, on average 2 weeks
Title
Variation in spatiotemporal gait parameters during the 2 Minutes Walking Test with and without the device using 3D accelerometers' system
Description
Spatiotemporal gait parameters: Cadence, Gait Speed, Step Duration, Stride Length, Cadence Asymmetry, Gait Speed Asymmetry, Stance Asymmetry, Stride Length Asymmetry
Time Frame
Visit 2 and 3, on average 2 weeks
Title
Variation in spatiotemporal gait parameters during the 10 Meters Walking Test with and without the device using 3D accelerometers' system
Description
Spatiotemporal gait parameters: Cadence, Gait Speed, Step Duration, Stride Length, Cadence Asymmetry, Gait Speed Asymmetry, Stance Asymmetry, Stride Length Asymmetry
Time Frame
Visit 2 and 3, on average 2 weeks
Title
Variation in kinematics parameters during 30 Sit To Stand with and without the device using 3D accelerometers' system
Description
Kinematics parameters: Gait Joint Angles, Stick Plot Visualization - Sagital plane, Hip-Knee & Knee-Ankle Plots
Time Frame
Visit 2 and 3, on average 2 weeks
Title
Variation in kinematics parameters during unique Sit To Stand with and without the device using 3D accelerometers' system
Description
Kinematics parameters: Gait Joint Angles, Stick Plot Visualization - Sagital plane, Hip-Knee & Knee-Ankle Plots
Time Frame
Visit 2 and 3, on average 2 weeks
Title
Variation in kinematics parameters during Time Up & Go evaluation with and without the device using 3D accelerometers' system
Description
Kinematics parameters: Gait Joint Angles, Stick Plot Visualization - Sagital plane, Hip-Knee & Knee-Ankle Plots
Time Frame
Visit 2 and 3, on average 2 weeks
Title
Variation in kinematics parameters during stairs climbing test with and without the device using 3D accelerometers' system
Description
Kinematics parameters: Gait Joint Angles, Stick Plot Visualization - Sagital plane, Hip-Knee & Knee-Ankle Plots
Time Frame
Visit 2 and 3, on average 2 weeks
Title
Modification of lower limb muscle recruitment measured by surface EMG with and without the device
Time Frame
Visit 2 and 3, on average 2 weeks
Title
Variation in postural stability measured by force platform with and without the device
Description
Mean Velocity, RMS Sway
Time Frame
Visit 2 and 3, on average 2 weeks
Title
Modification in scoring of the device measured by the Modified Nordic Questionnaire
Time Frame
Through study completion, on average 4 weeks
Title
Positive scoring of device efficiency measured by the System usability scale
Time Frame
Through study completion, on average 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years and < 70 years of age
Height between 1.50 m and 1.95 m
Weight between 45 kg and 110 kg
Abdominal perimeter < 125 cm
Written informed consent
Affiliate or beneficiary of a social security scheme
Able to comply with all protocol requirements
Confirmed diagnosis of a pathology belonging to one of the following family*:
Primary disorders of muscles
Muscular dystrophy
Congenital myopathies
Idiopathic inflammatory myopathy
Mitochondrial myopathies
Metabolic disorders
Inborn errors of metabolism
Glycogen storage disease
Functional capacities:
Able to stand up from a chair with armrest without other supports at least 3 times and at most 15 times in 30 seconds.
Report the ability to walk without the assistance of a person at least 2min
The use of traditional orthoses and walking aids will be accepted excepted knee orthoses and walkers (e.g. canes/crutches, ankle foot orthosis).
Exclusion Criteria:
Unable to participate in the study
Inability to comply with protocol requirements
Guardianship/trusteeship
Pregnant or nursing women
Unstable Cardiomyopathy
Symptomatic orthostatic hypotension
Medical history of osteoporotic fracture
Balance disorder with extra neuromuscular causes
Recent trauma (fall, accident, ...)
Unstable Cardiomyopathy
Severe respiratory insufficiency
Flexion contracture in the knee and hip joint in excess of 10°
Varus malposition in excess of 10° or valgus malposition in excess of 10°
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume Bassez, MD
Phone
01 42 16 66 43
Email
guillaume.bassez@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Damien Bachasson, PhD
Phone
01 42 16 58 79
Email
d.bachasson@institut-myologie.org
Facility Information:
Facility Name
Institute of Myology
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien Bachasson, PhD
Phone
01 42 16 58 79
Email
d.bachasson@institut-myologie.org
First Name & Middle Initial & Last Name & Degree
Erwan Gasnier, PhD
Phone
01 42 16 58 75
Email
e.gasnier@institut-myologie.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of Safety and Acute Effects of a Knee-hip Powered Soft Exoskeleton in Patients With Neuromuscular Disorders
We'll reach out to this number within 24 hrs