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Assessment of Safety and Acute Effects of a Lower-limb Powered Dermoskeleton in Patients With Neuromuscular Disorders (Exo-KGO1)

Primary Purpose

Muscular Dystrophies, Congenital Myopathy, Idiopathic Inflammatory Myopathies

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Lower-limb powered dermoskeleton
Sponsored by
Institut de Myologie, France
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Institute of MyologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lower-limb powered dermoskeleton

No assistance device

Arm Description

Patients and healthy subjects will use a lower-limb powered dermoskeleton to perform different standardised tasks

Patients and healthy subjects will perform different standardised tasks without lower-limb powered dermoskeleton

Outcomes

Primary Outcome Measures

Absence of adverse effect attributable to the use of the device during task performed within a lower-limb powered dermoskeleton

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

First Posted
December 2, 2021
Last Updated
September 26, 2023
Sponsor
Institut de Myologie, France
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1. Study Identification

Unique Protocol Identification Number
NCT05199246
Brief Title
Assessment of Safety and Acute Effects of a Lower-limb Powered Dermoskeleton in Patients With Neuromuscular Disorders
Acronym
Exo-KGO1
Official Title
Assessment of Safety and Acute Effects of a Lower-limb Powered Dermoskeleton in Patients With Neuromuscular Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (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 programmable ambulation exoskeleton (KeeogoTM Dermoskeleton System, B-Temia Inc., Quebec, Canada) 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, especially in proximal muscle groups (i.e. providing strength/torque to knees) is very high. In 2014, Bouyer et al. introduced a powered knee exoskeleton, a wearable device designed to increase movement capacity during different task (6MWT, TUG, Stair Test…). This dermoskeleton has been created to enhance and augment mobility through biomechanical assistance using motorized orthopedic supports controlled by computers. This device is mainly based on the interaction of three components: 1) a network to sense the biomechanical characteristics of a specific user; 2) software for movement recognition to characterize gait phases and movement status; and 3) software to control the dermoskeleton joint mechanism to optimize biomechanical assistance. McLeod et al. demonstrated that the KeeogoTM increased performance on the 30STS, SCT and improved motor control, postural control and movement kinetics during the STS task in a chronic stroke survivor with significant hemiparesis. Recently, McGibbon et al. proved that the KeeogoTM is able to deliver an exercise-mediated benefit to individuals with MS that improved their unassisted gait endurance and stair climbing ability. However, the effect of the device on movement parameters and user perception must be specifically investigated, especially considering neuromuscular patients' specificities. We believe that ambulant patients with such disorders may highly benefit from a system that provides mobility assistance like the KeeogoTM. The use of such a device has the potential to shift the loss of ambulation and/or transfer abilities to an higher age and might mitigate disease progression as well as the occurrence of complications. Whether the KeeogoTM 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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lower-limb powered dermoskeleton
Arm Type
Experimental
Arm Description
Patients and healthy subjects will use a lower-limb powered dermoskeleton 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 lower-limb powered dermoskeleton
Intervention Type
Device
Intervention Name(s)
Lower-limb powered dermoskeleton
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 lower-limb powered dermoskeleton
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
Central Contact Person:
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
First Name & Middle Initial & Last Name or Official Title & Degree
Erwan Gasnier, PhD
Phone
01 42 16 58 75
Email
e.gasnier@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

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Assessment of Safety and Acute Effects of a Lower-limb Powered Dermoskeleton in Patients With Neuromuscular Disorders

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