Muscular Dystrophies Clinical Trial
— Exo-NMD1Official title:
Assessment of Safety and Acute Effects of a Knee-hip Powered Soft Exoskeleton in Patients With Neuromuscular Disorders
NCT number | NCT05200702 |
Other study ID # | Exo-NMD1 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 5, 2022 |
Est. completion date | July 2024 |
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.
Status | Recruiting |
Enrollment | 52 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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° |
Country | Name | City | State |
---|---|---|---|
France | Institute of Myology | Paris |
Lead Sponsor | Collaborator |
---|---|
Institut de Myologie, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Absence of adverse effect attributable to the use of the device during task performed within a knee-hip powered soft exoskeleton | Through study completion, on average 4 weeks | ||
Secondary | Variation in the 2 Minutes Walking Test distance (express in meters) when performed using versus not using the device | Visit 2 and 3, on average 2 weeks | ||
Secondary | Variation in the 10 Meters Walking Test performance (express in seconds) when performed using versus not using the device | Visit 2 and 3, on average 2 weeks | ||
Secondary | Difference of performance with and without the device during 30 Sit To Stand | Visit 2 and 3, on average 2 weeks | ||
Secondary | Difference of performance with and without the device during simple Sit To Stand | Visit 2 and 3, on average 2 weeks | ||
Secondary | Difference of performance with and without the device during the squating test | Visit 2 and 3, on average 2 weeks | ||
Secondary | Difference of performance with and without the device during Time Up & Go test | Visit 2 and 3, on average 2 weeks | ||
Secondary | Difference of performance with and without the device during stairs climbing test | Visit 2 and 3, on average 2 weeks | ||
Secondary | 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 | Visit 2 and 3, on average 2 weeks | |
Secondary | 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 | Visit 2 and 3, on average 2 weeks | |
Secondary | 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 | Visit 2 and 3, on average 2 weeks | |
Secondary | 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 | Visit 2 and 3, on average 2 weeks | |
Secondary | 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 | Visit 2 and 3, on average 2 weeks | |
Secondary | 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 | Visit 2 and 3, on average 2 weeks | |
Secondary | Modification of lower limb muscle recruitment measured by surface EMG with and without the device | Visit 2 and 3, on average 2 weeks | ||
Secondary | Variation in postural stability measured by force platform with and without the device | Mean Velocity, RMS Sway | Visit 2 and 3, on average 2 weeks | |
Secondary | Modification in scoring of the device measured by the Modified Nordic Questionnaire | Through study completion, on average 4 weeks | ||
Secondary | Positive scoring of device efficiency measured by the System usability scale | Through study completion, on average 4 weeks |
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