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Assessments in Patients With Muscular Pathology and in Control Subjects : The ActiLiège Next Study

Primary Purpose

Duchenne Muscular Dystrophy, Fascioscapulohumeral Muscular Dystrophy

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
ActiMyo
Sponsored by
Laurent Servais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Duchenne Muscular Dystrophy

Eligibility Criteria

5 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Genetically confirmed diagnosis of DMD or FSHD. Between 5 and 20 years of age for patients with DMD, or between 5 and 80 years of age for patients with FSHD. Ambulant (as defined by having the ability to walk without assistance for 10 meters) or non-ambulant DMD patients. Ambulant FSHD patients Non-ambulant DMD patients must be able to remain seated in an arm- or a wheel-chair for at least one hour. Signed informed consent form by patient himself or, in case of minor patients, signed informed consent form by patient's parents or legal guardians. Exclusion Criteria: Patients with extreme cognitive disorders that limit their understanding of the exercises to be performed. Patients treated with corticosteroids for less than 6 months. Patients who have undergone a surgical procedure or who have experienced recent trauma (within fewer than 6 months) affecting the upper or lower limbs (for ambulant patients). A concomitant chronic or acute neurological, endocrine, infectious, allergic, or inflammatory pathology within the 3-week period immediately prior to inclusion. Patients who are participating in an interventional clinical trial.

Sites / Locations

  • CHR de la CitadelleRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with DMD/FSHD or control subjects

Arm Description

Patients and control subjects will be included over a one-year study period. Patients will be examined by a neuropaediatrician or neurologist and perform standardized assessments (timed tests, motor function tests, and strength tests) at baseline, 6 and 12 months. Patients will be asked to wear the device during one year. Control subjects will be examined by a physician and perform the same tests than those for ambulant patients at baseline and 12 months. Control subjects will be asked to wear the device for two months (one month at inclusion, one month 11 months after inclusion).

Outcomes

Primary Outcome Measures

Stride velocity
Stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
Stride length
Stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).
Stairs number
Total number of strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
Stairs speed
Vertical speed during strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
Stairs height
Height of the strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life

Secondary Outcome Measures

Full Information

First Posted
July 20, 2021
Last Updated
August 1, 2023
Sponsor
Laurent Servais
Collaborators
Sysnav
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1. Study Identification

Unique Protocol Identification Number
NCT05982119
Brief Title
Assessments in Patients With Muscular Pathology and in Control Subjects : The ActiLiège Next Study
Official Title
Gait Analysis Parameter, Stair Climbing and Upper Limb Evaluation in Patients With Muscular Pathology and in Control Subjects: The ActiLiège Next Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2020 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Laurent Servais
Collaborators
Sysnav

4. Oversight

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

5. Study Description

Brief Summary
The objective of ActiLiège Next Study is to collect natural history data in Duchenne muscular dystrophy (DMD) (ambulatory and non-ambulatory patients), and in affected patients with Facio-Scapulo-Humeral dystrophy (FSHD), a disease in which results are currently lacking. It consists of obtaining longitudinal data for the patients, as well as normative data for the control subjects, with a particular emphasis on pediatric subjects using the device on both ankles (for walking) in order to qualify the ascent rate of staircase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duchenne Muscular Dystrophy, Fascioscapulohumeral Muscular Dystrophy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with DMD/FSHD or control subjects
Arm Type
Other
Arm Description
Patients and control subjects will be included over a one-year study period. Patients will be examined by a neuropaediatrician or neurologist and perform standardized assessments (timed tests, motor function tests, and strength tests) at baseline, 6 and 12 months. Patients will be asked to wear the device during one year. Control subjects will be examined by a physician and perform the same tests than those for ambulant patients at baseline and 12 months. Control subjects will be asked to wear the device for two months (one month at inclusion, one month 11 months after inclusion).
Intervention Type
Device
Intervention Name(s)
ActiMyo
Intervention Description
The two "watches" can be worn as wristwatch or placed near the ankle and on the wheelchair. Patients will wear the ActiMyo° during one year in order to collect natural history data in DMD and FSHD. Control subjects will wear the ActiMyo° during one month after inclusion and during one other month 11 months after inclusion.
Primary Outcome Measure Information:
Title
Stride velocity
Description
Stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
Time Frame
through study completion (3 year)
Title
Stride length
Description
Stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).
Time Frame
through study completion (3 year)
Title
Stairs number
Description
Total number of strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
Time Frame
through study completion (3 year)
Title
Stairs speed
Description
Vertical speed during strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
Time Frame
through study completion (3 year)
Title
Stairs height
Description
Height of the strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
Time Frame
through study completion (3 year)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Genetically confirmed diagnosis of DMD or FSHD. Between 5 and 20 years of age for patients with DMD, or between 5 and 80 years of age for patients with FSHD. Ambulant (as defined by having the ability to walk without assistance for 10 meters) or non-ambulant DMD patients. Ambulant FSHD patients Non-ambulant DMD patients must be able to remain seated in an arm- or a wheel-chair for at least one hour. Signed informed consent form by patient himself or, in case of minor patients, signed informed consent form by patient's parents or legal guardians. Exclusion Criteria: Patients with extreme cognitive disorders that limit their understanding of the exercises to be performed. Patients treated with corticosteroids for less than 6 months. Patients who have undergone a surgical procedure or who have experienced recent trauma (within fewer than 6 months) affecting the upper or lower limbs (for ambulant patients). A concomitant chronic or acute neurological, endocrine, infectious, allergic, or inflammatory pathology within the 3-week period immediately prior to inclusion. Patients who are participating in an interventional clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manon Duclos
Phone
003243215586
Email
manon.duclos@chrcitadelle.be
First Name & Middle Initial & Last Name or Official Title & Degree
Charline Dubois
Phone
003243215695
Email
charline.dubois@chrcitadelle.be
Facility Information:
Facility Name
CHR de la Citadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manon Duclos
Phone
003243215586
Email
manon.duclos@chrcitadelle.be
First Name & Middle Initial & Last Name & Degree
Charline Dubois
Phone
003243215695
Email
charline.dubois@chrcitadelle.be

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessments in Patients With Muscular Pathology and in Control Subjects : The ActiLiège Next Study

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