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

• ClinicalTrials.gov Identifier: NCT05199246
• Recruitment Status: Recruiting
• First Posted: January 20, 2022
• Sponsor: Institut de Myologie, France
• Information provided by (Responsible Party): Institut de Myologie, France

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.

Condition or disease	Intervention/treatment	Phase
Muscular Dystrophies; Congenital Myopathy; Idiopathic Inflammatory Myopathies; Mitochondrial Myopathies; Glycogen Storage Disease	Device: Lower-limb powered dermoskeleton	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 52 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Assessment of Safety and Acute Effects of a Lower-limb Powered Dermoskeleton in Patients With Neuromuscular Disorders
• Actual Study Start Date: December 1, 2021
• Estimated Primary Completion Date: July 2023
• Estimated Study Completion Date: July 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Lower-limb powered dermoskeleton; Patients and healthy subjects will use a lower-limb powered dermoskeleton to perform different standardised tasks	Device: Lower-limb powered dermoskeleton; Patients and healthy subjects will wear the movement assistance device to perform different standardised physical evaluations.
No Intervention: No assistance device; Patients and healthy subjects will perform different standardised tasks without lower-limb powered dermoskeleton

Outcome Measures

Primary Outcome Measures :

1. 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 Measures :

1. 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 ]
2. 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 ]
3. Difference of performance with and without the device during 30 Sit To Stand [ Time Frame: Visit 2 and 3, on average 2 weeks ]
4. Difference of performance with and without the device during simple Sit To Stand [ Time Frame: Visit 2 and 3, on average 2 weeks ]
5. Difference of performance with and without the device during the squating test [ Time Frame: Visit 2 and 3, on average 2 weeks ]
6. Difference of performance with and without the device during Time Up & Go test [ Time Frame: Visit 2 and 3, on average 2 weeks ]
7. Difference of performance with and without the device during stairs climbing test [ Time Frame: Visit 2 and 3, on average 2 weeks ]
8. Variation in spatiotemporal gait parameters during the 2 Minutes Walking Test with and without the device using 3D accelerometers' system [ Time Frame: Visit 2 and 3, on average 2 weeks ]
   Spatiotemporal gait parameters: Cadence, Gait Speed, Step Duration, Stride Length, Cadence Asymmetry, Gait Speed Asymmetry, Stance Asymmetry, Stride Length Asymmetry
9. Variation in spatiotemporal gait parameters during the 10 Meters Walking Test with and without the device using 3D accelerometers' system [ Time Frame: Visit 2 and 3, on average 2 weeks ]
   Spatiotemporal gait parameters: Cadence, Gait Speed, Step Duration, Stride Length, Cadence Asymmetry, Gait Speed Asymmetry, Stance Asymmetry, Stride Length Asymmetry
10. Variation in kinematics parameters during 30 Sit To Stand with and without the device using 3D accelerometers' system [ Time Frame: Visit 2 and 3, on average 2 weeks ]
    Kinematics parameters: Gait Joint Angles, Stick Plot Visualization - Sagital plane, Hip-Knee & Knee-Ankle Plots
11. Variation in kinematics parameters during unique Sit To Stand with and without the device using 3D accelerometers' system [ Time Frame: Visit 2 and 3, on average 2 weeks ]
    Kinematics parameters: Gait Joint Angles, Stick Plot Visualization - Sagital plane, Hip-Knee & Knee-Ankle Plots
12. Variation in kinematics parameters during Time Up & Go evaluation with and without the device using 3D accelerometers' system [ Time Frame: Visit 2 and 3, on average 2 weeks ]
    Kinematics parameters: Gait Joint Angles, Stick Plot Visualization - Sagital plane, Hip-Knee & Knee-Ankle Plots
13. Variation in kinematics parameters during Stairs Climbing Test with and without the device using 3D accelerometers' system [ Time Frame: Visit 2 and 3, on average 2 weeks ]
    Kinematics parameters: Gait Joint Angles, Stick Plot Visualization - Sagital plane, Hip-Knee & Knee-Ankle Plots
14. 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 ]
15. Variation in postural stability measured by force platform with and without the device [ Time Frame: Visit 2 and 3, on average 2 weeks ]
    Mean Velocity, RMS Sway
16. Modification in scoring of the device measured by the Modified Nordic Questionnaire [ Time Frame: Through study completion, on average 4 weeks ]
17. Positive scoring of device efficiency measured by the System usability scale [ Time Frame: Through study completion, on average 4 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Damien Bachasson, PhD; 01 42 16 58 79; d.bachasson@institut-myologie.org

Contact: Erwan Gasnier, PhD; 01 42 16 58 75; e.gasnier@institut-myologie.org

Locations

France

Institute of Myology; Recruiting

Paris, France, 75013

Contact: Damien Bachasson, PhD 01 42 16 58 79 d.bachasson@institut-myologie.org

Contact: Erwan Gasnier, PhD 01 42 16 58 75 e.gasnier@institut-myologie.org

Sponsors and Collaborators

Institut de Myologie, France

More Information

• Responsible Party: Institut de Myologie, France
• ClinicalTrials.gov Identifier: NCT05199246
• Other Study ID Numbers: Exo-KGO1
• First Posted: January 20, 2022
• Last Update Posted: March 2, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut de Myologie, France:

Neuromuscular disorders; Myopathy; Muscle; Exoskeleton; Device; Motion assistance; FSHD; LGMD

Additional relevant MeSH terms:

Muscular Dystrophies; Muscular Diseases; Myositis; Mitochondrial Myopathies; Neuromuscular Diseases; Glycogen Storage Disease; Muscular Disorders, Atrophic; Musculoskeletal Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Mitochondrial Diseases