- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07136844
- Original Trial
Gait Analysis Parameter and Upper Limb Evaluation in Adult Patients With Neurological or Metabolic Pathology (Acti-Adult)
Study Overview
Status
Conditions
- Neuromuscular Diseases
- Myasthenia Gravis
- Huntington Disease
- Myotonic Dystrophy 1
- Hereditary Spastic Paraplegia
- Ataxia, Spinocerebellar
- Progressive Supranuclear Palsy (PSP)
- Facio-Scapulo-Humeral Dystrophy
- Obesity (Disorder)
- Glycogen Storage Disease Type II Pompe Disease
- Charcot Marie Tooth Disease (CMT)
- Myasthenic Syndrome
Intervention / Treatment
- Diagnostic test: The Timed up and go test (TUG)
- Device: Syde
- Diagnostic test: The 6-minute walk test (6MWT)
- Diagnostic test: The 10-meter test (10MWT)
- Diagnostic test: The 4 stair-climbing test (4SC)
- Diagnostic test: Test of rising from the floor (TRF)
- Other: Patient's Global Impression of Change (PGIC)
- Diagnostic test: Dynamometric measurements of muscle strength
- Diagnostic test: The Charcot-Marie-Tooth examination score (CMTES)
- Diagnostic test: 9-Hole Peg Test (9-HPT)
- Diagnostic test: The Scale for the Assessment and Rating of Ataxia (SARA)
- Diagnostic test: The Unified Huntington's Disease Rating Scale (UHDRS)
- Diagnostic test: The Progressive Supranuclear Palsy Rating Scale (PSP-RS)
- Diagnostic test: The Montreal Cognitive Assessment (MOCA)
- Diagnostic test: Quantitative Myasthenia Gravis (QMG)
- Diagnostic test: The Myasthenia Gravis Activities of Daily Living Scale (MG-ADL)
Detailed Description
Following the qualification of the 95th centile of stride velocity (SV95C) as a primary digital endpoint in Duchenne muscular dystrophy (DMD), there is growing interest in extending such digital assessments to other neurological and metabolic diseases that impair movement. Traditional in-clinic functional tests (e.g., 6-minute walk test, 10-meter walk/run) provide only limited snapshots of motor ability and are influenced by external factors such as motivation and fatigue. Similarly, motor function scales and biomarkers, while useful, often lack objectivity or established clinical relevance.
The ActiLiège-Adult study aims to address these limitations by leveraging the Syde® device, a wearable magneto-inertial sensor worn on the wrist and/or ankle, to continuously monitor motor activity in daily life. This device has been previously validated in DMD and other neuromuscular conditions and has been used in both interventional and natural history studies.
This academic study will enroll 300 ambulant adult patients, including 220 with neurological diseases and 20 with obesity, with a minimum of 20 patients per disease type. Ambulation is defined as the ability to walk 10 meters unaided. Patients who lose ambulation during the study will continue to be followed with adapted assessments.
Participants will be monitored for up to two years (six months for diseases affecting the neuromuscular junction). Standardized clinical assessments-including timed tests, motor function evaluations, and strength measurements-will be conducted at baseline and every six months. These will be compared with continuous data collected by the Syde® device. Additionally, patients will complete a Patient Global Impression of Change (PGI-C) questionnaire every six months.
The study's goal is to generate robust, real-world data to support the development of objective, sensitive, and clinically meaningful digital endpoints for use in future therapeutic trials targeting movement disorders.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nicolas Bovy
- Phone Number: +3243218095
- Email: Nicolas.Bovy@citadelle.be
Study Locations
-
-
-
Liège, Belgium, 4000
- Recruiting
- Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle
-
Principal Investigator:
- Laurent Servais, MD
-
Contact:
- Nicolas Bovy
- Phone Number: +3243218095
- Email: Nicolas.Bovy@citadelle.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Obese patients
|
Syde is an innovative device intended to be used in a home-based environment.
It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.
This test consists of covering the greatest possible distance within 6 minutes, walking back and forth along a 25-meter hallway.
The subject may stop if they need to.
The evaluator will record the elapsed time after each half-lap, and the final distance that was covered at the end of the test.
No help will be allowed during the test.
During this test, the subject must cover a distance of 10 meters as rapidly as possible.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test.
No help will be allowed during the test.
This is a standardized test during which the subject must climb the 4 stair steps as rapidly as possible.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test, or more if needed.
This is a standardized test during which the subject must rise from the floor as rapidly as possible.
The test starts with the participant lying on their back.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test.
PGIC is a patient-reported scale used to assess how a patient feels their condition has changed over time.
It typically uses a 7-point scale to capture the patient's overall perception of improvement in symptoms, function, and quality of life.
|
|
Experimental: Neuromuscular condition - Muscle disease
|
Syde is an innovative device intended to be used in a home-based environment.
It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.
This test consists of covering the greatest possible distance within 6 minutes, walking back and forth along a 25-meter hallway.
The subject may stop if they need to.
The evaluator will record the elapsed time after each half-lap, and the final distance that was covered at the end of the test.
No help will be allowed during the test.
During this test, the subject must cover a distance of 10 meters as rapidly as possible.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test.
No help will be allowed during the test.
This is a standardized test during which the subject must climb the 4 stair steps as rapidly as possible.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test, or more if needed.
This is a standardized test during which the subject must rise from the floor as rapidly as possible.
The test starts with the participant lying on their back.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test.
PGIC is a patient-reported scale used to assess how a patient feels their condition has changed over time.
It typically uses a 7-point scale to capture the patient's overall perception of improvement in symptoms, function, and quality of life.
|
|
Experimental: Neuromuscular condition - Neuropathy
|
Syde is an innovative device intended to be used in a home-based environment.
It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.
This test consists of covering the greatest possible distance within 6 minutes, walking back and forth along a 25-meter hallway.
The subject may stop if they need to.
The evaluator will record the elapsed time after each half-lap, and the final distance that was covered at the end of the test.
No help will be allowed during the test.
During this test, the subject must cover a distance of 10 meters as rapidly as possible.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test.
No help will be allowed during the test.
This is a standardized test during which the subject must climb the 4 stair steps as rapidly as possible.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test, or more if needed.
This is a standardized test during which the subject must rise from the floor as rapidly as possible.
The test starts with the participant lying on their back.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test.
PGIC is a patient-reported scale used to assess how a patient feels their condition has changed over time.
It typically uses a 7-point scale to capture the patient's overall perception of improvement in symptoms, function, and quality of life.
Dynamometric measurements of the maximum force of the following functions will be taken with the MyoTools: palmar grip (MyoGrip) and thumb-index pinch (MyoPinch).
Test will be realized on the dominant side.
Patients will be encouraged during the test.
They will be given three trials and the best score will be entered.
The CMTES is a 28-point composite score that rates the patient's symptoms and signs.
It is part of the Charcot-Marie-Tooth (CMT) neuropathy score and has been validated as a reproducible measure of disability in CMT.
Higher scores indicate more severe neuropathy.
The 9-HPT is a quantitative test of upper limb function.
It is the second component of the Multiple Sclerosis Functional Composite (MSFC).
The patient sits at a table with a shallow container containing nine sticks and a wooden or plastic block containing nine empty holes.
When a timer is started, the patient places the nine sticks one after the other as quickly as possible into the nine holes and, once they are all in the holes, removes them as quickly as possible.
The total time taken to complete the task is recorded.
Two consecutive attempts with the dominant hand are immediately followed by two consecutive attempts with the non-dominant hand.
|
|
Experimental: Ataxia
|
Syde is an innovative device intended to be used in a home-based environment.
It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.
This test consists of covering the greatest possible distance within 6 minutes, walking back and forth along a 25-meter hallway.
The subject may stop if they need to.
The evaluator will record the elapsed time after each half-lap, and the final distance that was covered at the end of the test.
No help will be allowed during the test.
During this test, the subject must cover a distance of 10 meters as rapidly as possible.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test.
No help will be allowed during the test.
This is a standardized test during which the subject must climb the 4 stair steps as rapidly as possible.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test, or more if needed.
This is a standardized test during which the subject must rise from the floor as rapidly as possible.
The test starts with the participant lying on their back.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test.
PGIC is a patient-reported scale used to assess how a patient feels their condition has changed over time.
It typically uses a 7-point scale to capture the patient's overall perception of improvement in symptoms, function, and quality of life.
The 9-HPT is a quantitative test of upper limb function.
It is the second component of the Multiple Sclerosis Functional Composite (MSFC).
The patient sits at a table with a shallow container containing nine sticks and a wooden or plastic block containing nine empty holes.
When a timer is started, the patient places the nine sticks one after the other as quickly as possible into the nine holes and, once they are all in the holes, removes them as quickly as possible.
The total time taken to complete the task is recorded.
Two consecutive attempts with the dominant hand are immediately followed by two consecutive attempts with the non-dominant hand.
This 8-item scale was developed to assess ataxia severity and disease progression.
It evaluates gait and balance, speech, and upper and lower limb coordination.
The score ranges from 0 to 40, with higher score indicating a worse clinical outcome.
|
|
Experimental: Huntington disease (HD) and HD-like
|
Syde is an innovative device intended to be used in a home-based environment.
It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.
This test consists of covering the greatest possible distance within 6 minutes, walking back and forth along a 25-meter hallway.
The subject may stop if they need to.
The evaluator will record the elapsed time after each half-lap, and the final distance that was covered at the end of the test.
No help will be allowed during the test.
During this test, the subject must cover a distance of 10 meters as rapidly as possible.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test.
No help will be allowed during the test.
This is a standardized test during which the subject must climb the 4 stair steps as rapidly as possible.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test, or more if needed.
This is a standardized test during which the subject must rise from the floor as rapidly as possible.
The test starts with the participant lying on their back.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test.
PGIC is a patient-reported scale used to assess how a patient feels their condition has changed over time.
It typically uses a 7-point scale to capture the patient's overall perception of improvement in symptoms, function, and quality of life.
This 74-item clinical rating scale assesses patient performance and capacity in 4 domains: motor function, cognitive function, behavioral abnormalities, and functional capacity.
|
|
Experimental: Progressive supranuclear palsy (PSP) and PSP-like
|
During this standardized test, the subject is observed and timed while he/she rises from a chair, walks 3 meters, performs a 180° turn, walk back toward the chair and sits down.
Syde is an innovative device intended to be used in a home-based environment.
It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.
This test consists of covering the greatest possible distance within 6 minutes, walking back and forth along a 25-meter hallway.
The subject may stop if they need to.
The evaluator will record the elapsed time after each half-lap, and the final distance that was covered at the end of the test.
No help will be allowed during the test.
During this test, the subject must cover a distance of 10 meters as rapidly as possible.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test.
No help will be allowed during the test.
This is a standardized test during which the subject must climb the 4 stair steps as rapidly as possible.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test, or more if needed.
This is a standardized test during which the subject must rise from the floor as rapidly as possible.
The test starts with the participant lying on their back.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test.
PGIC is a patient-reported scale used to assess how a patient feels their condition has changed over time.
It typically uses a 7-point scale to capture the patient's overall perception of improvement in symptoms, function, and quality of life.
This 28-item clinician-rated scale assesses motor and non-motor symptom severity in patients with PSP, with a score ranging from 0 (normal) to 100.
The MOCA was designed as a rapid screening instrument for mild cognitive dysfunction.
It assesses different cognitive domains: attention and concentration, executive function, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
Scores on the MOCA range from 0 to 30, with higher score being better outcome.
|
|
Experimental: Spastic paraplesia and conditions where spasticity predominates, incl. stroke
|
Syde is an innovative device intended to be used in a home-based environment.
It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.
This test consists of covering the greatest possible distance within 6 minutes, walking back and forth along a 25-meter hallway.
The subject may stop if they need to.
The evaluator will record the elapsed time after each half-lap, and the final distance that was covered at the end of the test.
No help will be allowed during the test.
During this test, the subject must cover a distance of 10 meters as rapidly as possible.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test.
No help will be allowed during the test.
This is a standardized test during which the subject must climb the 4 stair steps as rapidly as possible.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test, or more if needed.
This is a standardized test during which the subject must rise from the floor as rapidly as possible.
The test starts with the participant lying on their back.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test.
PGIC is a patient-reported scale used to assess how a patient feels their condition has changed over time.
It typically uses a 7-point scale to capture the patient's overall perception of improvement in symptoms, function, and quality of life.
|
|
Experimental: Neuromuscular condition - Neuromuscular Junction
|
Syde is an innovative device intended to be used in a home-based environment.
It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.
This test consists of covering the greatest possible distance within 6 minutes, walking back and forth along a 25-meter hallway.
The subject may stop if they need to.
The evaluator will record the elapsed time after each half-lap, and the final distance that was covered at the end of the test.
No help will be allowed during the test.
During this test, the subject must cover a distance of 10 meters as rapidly as possible.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test.
No help will be allowed during the test.
This is a standardized test during which the subject must climb the 4 stair steps as rapidly as possible.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test, or more if needed.
This is a standardized test during which the subject must rise from the floor as rapidly as possible.
The test starts with the participant lying on their back.
This test will be performed 3 times.
The participant will be allowed to rest for one minute after the first and second instances of the test.
PGIC is a patient-reported scale used to assess how a patient feels their condition has changed over time.
It typically uses a 7-point scale to capture the patient's overall perception of improvement in symptoms, function, and quality of life.
The QMG is a clinician-rated 13-item scale used to quantify disease severity in patients with MG.
The scale grades each domain (ocular, bulbar, respiratory, and limb function), with a total score ranging from 0 to 39 (lower score indicating a better clinical outcome).
This is an 8-item patient-reported scale assessing MG symptoms and their effects on daily activities.
The score ranges from 0 to 24, with higher score indicating a worse clinical outcome.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
95th Centile of Stride Velocity (SV95C)
Time Frame: Every 6 months for up to 2 years
|
Change in SV95C as measured by the Syde® wearable device, used to assess ambulatory function in real-life settings.
|
Every 6 months for up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Device Acceptability and Adherence
Time Frame: Over 2 years
|
Measures of user engagement with the Syde® device over time, including total recording time, valid days (≥5 hours), and time to reach 50 and 180 hours.
|
Over 2 years
|
|
Correlation between Syde® and 6MWT
Time Frame: Every 6 months for up to 2 years
|
Correlation between the Syde digital variable and results from the 6-minute walk test (6MWT)
|
Every 6 months for up to 2 years
|
|
Correlation between Syde® and 10MWT
Time Frame: Every 6 months for up to 2 years
|
Correlation between the Syde digital variable and results from the 10-meter test (10MWT)
|
Every 6 months for up to 2 years
|
|
Correlation between Syde® and 4SC
Time Frame: Every 6 months for up to 2 years
|
Correlation between the Syde digital variable and results from the 4 stair-climbing test (4SC)
|
Every 6 months for up to 2 years
|
|
Correlation between Syde® and TRF
Time Frame: Every 6 months for up to 2 years
|
Correlation between the Syde digital variable and results from the test of rising from the floor (TRF)
|
Every 6 months for up to 2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Laurent Servais, MD, Centre Hospitalier Universitaire de Liège
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Muscular Diseases
- Mental Disorders
- Nutrition Disorders
- Neoplasms by Site
- Neoplasms
- Metabolism, Inborn Errors
- Genetic Diseases, Inborn
- Metabolic Diseases
- Overnutrition
- Body Weight
- Autoimmune Diseases
- Immune System Diseases
- Peripheral Nervous System Diseases
- Neurocognitive Disorders
- Eye Diseases
- Autoimmune Diseases of the Nervous System
- Cognition Disorders
- Dementia
- Tauopathies
- Neurodegenerative Diseases
- Congenital Abnormalities
- Movement Disorders
- Paraneoplastic Syndromes, Nervous System
- Nervous System Neoplasms
- Paraneoplastic Syndromes
- Neuromuscular Junction Diseases
- Heredodegenerative Disorders, Nervous System
- Overweight
- Muscular Disorders, Atrophic
- Carbohydrate Metabolism, Inborn Errors
- Lysosomal Storage Diseases
- Basal Ganglia Diseases
- Cranial Nerve Diseases
- Spinal Cord Diseases
- Brain Diseases, Metabolic, Inborn
- Brain Diseases, Metabolic
- Nervous System Malformations
- Dyskinesias
- Polyneuropathies
- Ophthalmoplegia
- Ocular Motility Disorders
- Paralysis
- Lysosomal Storage Diseases, Nervous System
- Chorea
- Cerebellar Diseases
- Cerebellar Ataxia
- Muscular Dystrophies
- Myotonic Disorders
- Ataxia
- Obesity
- Lambert-Eaton Myasthenic Syndrome
- Myotonic Dystrophy
- Myasthenia Gravis
- Tooth Diseases
- Charcot-Marie-Tooth Disease
- Nerve Compression Syndromes
- Hereditary Sensory and Motor Neuropathy
- Supranuclear Palsy, Progressive
- Glycogen Storage Disease Type II
- Glycogen Storage Disease
- Muscular Dystrophy, Facioscapulohumeral
- Huntington Disease
- Spinocerebellar Ataxias
- Spinocerebellar Degenerations
- Neuromuscular Diseases
- Paraplegia
- Spastic Paraplegia, Hereditary
Other Study ID Numbers
- ActiLiège Adult
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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