Evaluating a powered exoskeleton for patients with neuromuscular disorders

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

This study is testing a special walking aid called the Keeogo Dermoskeleton to see if it can help people with muscle disorders move better and gain more independence.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Institut de Myologie, France (other)
• Locations: 1 site (Paris)
• Trial ID: NCT05199246 on ClinicalTrials.gov

What this trial studies

This study assesses the safety, usability, and immediate effectiveness of the KeeogoTM Dermoskeleton System, a programmable ambulation exoskeleton, in individuals with various neuromuscular disorders. It aims to identify usability criteria for the device based on patients' functional deficits and gather data to support future studies on long-term home use. The focus is on improving mobility and independence for patients suffering from conditions like muscular dystrophies and myopathies, which often lead to severe muscle weakness and reduced quality of life.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with confirmed diagnoses of specific neuromuscular or metabolic disorders and certain functional capabilities.

Not a fit: Patients who are unable to stand up from a chair or walk independently for at least 2 minutes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance mobility and independence for patients with neuromuscular disorders, significantly improving their quality of life.

How similar studies have performed: Previous studies using powered exoskeletons have shown promise in improving mobility for patients with similar conditions, indicating potential for success in this approach.

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

Where this trial is running

Paris

• Institute of Myology — Paris, France (RECRUITING)

Study contacts

• Study coordinator: Damien Bachasson, PhD

Conditions: Muscular Dystrophies, Congenital Myopathy, Idiopathic Inflammatory Myopathies, Mitochondrial Myopathies, Glycogen Storage Disease, Neuromuscular disorders, Myopathy, Muscle