Acti-Adult
Recruiting
Official title: Gait Analysis Parameter and Upper Limb Evaluation in Adult Patients With Neurological or Metabolic Pathology
This trial is trying to better understand how people with movement problems actually walk and move in their everyday lives.
It takes place in Liège, Belgium, and includes about 300 adults who can still walk but have conditions that affect their movement, such as muscle diseases or obesity.
Instead of only testing people in a clinic, participants wear a small device called the Syde wearable device. This device tracks how they move throughout the day for up to two years—at home, outside, and in normal daily life.
The goal is to see if this kind of real-world data can give a clearer, more accurate picture of how well someone moves. For example, researchers look at how fast someone walks at their quicker moments during the day (not just their average speed).
If this works, it could make future medical studies better by giving doctors more reliable ways to measure whether treatments are actually helping people move better.
The diseases will include:
- Neuromuscular Diseases
- Obesity (Disorder)
- Myotonic Dystrophy 1
- Myasthenic Syndrome
- Charcot Marie Tooth Disease (CMT)
- Glycogen Storage Disease Type II Pompe Disease
- Facio-Scapulo-Humeral Dystrophy
- Myasthenia Gravis
- Huntington Disease
- Progressive Supranuclear Palsy (PSP)
- Hereditary Spastic Paraplegia
- Ataxia, Spinocerebellar
This an open label.
Phase: not applicable
Subtype: Interventional Biomarker
Primary Purpose: Diagnostic
Primary Intervention: wearable and diagnostic tests
Ages Eligible
for Study:
18 Years and older
Sexes Eligible
for Study:
All
Accepts Healthy Volunteers:
No
- Ambulant patients (i.e. able to walk 10 meters without assistance)
Confirmed diagnosis by the investigator based on current gold standard in his/her disease (genetic testing, clinical criteria, etc.)
- Myotonic dystrophy type 1 (DM1) and Charcot-Marie-Tooth (CMT) patients should present sensitive of motor signs on physical examination.
- Myasthenic patients should be seropositive, and Myasthenia Gravis Foundation of America (MGFA) class II to IV.
- Patient with morbid obesity (Body Mass Index> or = 35 at inclusion visit).
- Signed informed consent form by patient him/herself and patient willing and able to comply with all study procedures.
- Non-ambulant patients
- Patients with extreme cognitive disorders that limit their understanding of the exercises to be performed
- Patients who have undergone a surgical procedure or who have experienced recent trauma (within fewer than 6 months) affecting the upper or lower limbs
- 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
- Pregnant or breastfeeding women
LOCATION
BELGIUM
TRIAL SITE:
Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle
Address: Liege, Belgium
CONTACT:Nicolas Bovy
