NCT05199246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2025

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

3.4 years

First QC Date

December 2, 2021

Last Update Submit

April 13, 2026

Conditions

Muscular DystrophiesCongenital MyopathyIdiopathic Inflammatory MyopathiesMitochondrial MyopathiesGlycogen Storage Disease

Keywords

Neuromuscular disordersMyopathyMuscleExoskeletonDeviceMotion assistanceFSHDLGMD

Outcome Measures

Primary Outcomes (1)

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

    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

  • +12 more secondary outcomes

Study Arms (2)

Lower-limb powered dermoskeleton

EXPERIMENTAL

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

Device: Lower-limb powered dermoskeleton

No assistance device

NO INTERVENTION

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

Interventions

Lower-limb powered dermoskeletonDEVICE

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

Lower-limb powered dermoskeleton

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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
  • +5 more criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Myology

Paris, 75013, France

Location

MeSH Terms

Conditions

Muscular DystrophiesMyotonia CongenitaMyositisMitochondrial MyopathiesGlycogen Storage DiseaseNeuromuscular DiseasesMuscular Diseases

Condition Hierarchy (Ancestors)

Muscular Disorders, AtrophicMusculoskeletal DiseasesNervous System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMyotonic DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesMitochondrial DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesCarbohydrate Metabolism, Inborn ErrorsMetabolism, 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

Study Record Dates

First Submitted

December 2, 2021

First Posted

January 20, 2022

Study Start

December 1, 2021

Primary Completion

April 22, 2025

Study Completion

April 22, 2025

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)