Assessment of Safety and Acute Effects of a Knee-hip Powered Soft Exoskeleton in Patients With Neuromuscular Disorders

NCT05200702 | Completed

• 1 other identifier: Exo-NMD1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscular Dystrophies; Congenital Myopathy; Idiopathic Inflammatory Myopathies; Mitochondrial Myopathies; Glycogen Storage Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• 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

• 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

• Difference of performance with and without the device during 30 Sit To Stand

  Visit 2 and 3, on average 2 weeks

• Difference of performance with and without the device during simple Sit To Stand

  Visit 2 and 3, on average 2 weeks

• Difference of performance with and without the device during the squating test

  Visit 2 and 3, on average 2 weeks

Study Arms (2)

Knee-hip Powered Soft Exoskeleton

EXPERIMENTAL

Patients and healthy subjects will use a Knee-hip Powered Soft Exoskeleton to perform different standardised tasks

Device: Knee-hip Powered Soft Exoskeleton (MyoSuit, MyoSwiss, Zurich, Switzerland)

No assistance device

NO INTERVENTION

Patients and healthy subjects will perform different standardised tasks without Knee-hip Powered Soft Exoskeleton

Interventions

Knee-hip Powered Soft Exoskeleton (MyoSuit, MyoSwiss, Zurich, Switzerland) DEVICE

Patients and healthy subjects will wear the movement assistance device to perform different standardised physical evaluations.

Knee-hip Powered Soft Exoskeleton

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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°

Sponsors & Collaborators

• Institut de Myologie, France: lead

Study Sites (1)

Institute of Myology

Paris, 75013, France

Location

MeSH Terms

Conditions

Muscular Dystrophies; Myotonia Congenita; Myositis; Mitochondrial Myopathies; Glycogen Storage Disease; Neuromuscular Diseases; Muscular Diseases

Condition Hierarchy (Ancestors)

Muscular Disorders, Atrophic; Musculoskeletal Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Myotonic Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Mitochondrial Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison of the results obtained during different standardized physical evaluations by patients and healthy subjects, with or without a movement assistance device.

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 21, 2022
• Study Start: January 5, 2022
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)