Assessments in Patients With Muscular Pathology and in Control Subjects : The ActiLiège Next Study
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Patients with DMD/FSHD or control subjects 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). |
Device: ActiMyo
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.
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Outcome Measures
Primary Outcome Measures
- Stride velocity [through study completion (3 year)]
Stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
- Stride length [through study completion (3 year)]
Stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).
- Stairs number [through study completion (3 year)]
Total number of strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
- Stairs speed [through study completion (3 year)]
Vertical speed during strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
- Stairs height [through study completion (3 year)]
Height of the strides in stairs obtained with a magneto-inertial sensor (Actimyo°) in real-life
Eligibility Criteria
Criteria
Inclusion Criteria:
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Genetically confirmed diagnosis of DMD or FSHD.
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Between 5 and 20 years of age for patients with DMD, or between 5 and 80 years of age for patients with FSHD.
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Ambulant (as defined by having the ability to walk without assistance for 10 meters) or non-ambulant DMD patients.
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Ambulant FSHD patients
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Non-ambulant DMD patients must be able to remain seated in an arm- or a wheel-chair for at least one hour.
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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:
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Patients with extreme cognitive disorders that limit their understanding of the exercises to be performed.
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Patients treated with corticosteroids for less than 6 months.
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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).
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A concomitant chronic or acute neurological, endocrine, infectious, allergic, or inflammatory pathology within the 3-week period immediately prior to inclusion.
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Patients who are participating in an interventional clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHR de la Citadelle | Liège | Belgium | 4000 |
Sponsors and Collaborators
- Laurent Servais
- Sysnav
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ActiLiege Next