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NCT Number: NCT07136844

Gait Analysis Parameter and Upper Limb Evaluation in Adult Patients With Neurological or Metabolic Pathology

The ActiLiège-Adult study is a prospective, longitudinal, observational study designed to collect natural history data on adult patients with neurological or metabolic diseases affecting movement. Conducted at the Centre de Référence Liégeois des Maladies Neuromusculaires in Liège, Belgium, the study will enroll 300 ambulant patients, including individuals with neuromuscular disorders and obesity. Using the Syde® wearable device, the study aims to continuously monitor motor function in real-life settings over a period of up to two years. The primary objective is to evaluate the utility of digital mobility outcomes, such as the 95th centile of stride velocity (SV95C), as reliable and objective endpoints for future clinical trials.

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Key information

Conditions

Neuromuscular Diseases Ataxia Ataxia, Spinocerebellar Autoimmune Diseases Autoimmune Diseases of the Nervous System Basal Ganglia Diseases Body Weight Brain Diseases Central Nervous System Diseases Cerebellar Ataxia Cerebellar Diseases Charcot Marie Tooth Disease (CMT) Charcot-Marie-Tooth Disease Chorea Cognition Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Nerve Diseases Dementia Dyskinesias Eye Diseases Facio-Scapulo-Humeral Dystrophy Genetic Diseases, Inborn Glycogen Storage Disease Type II Pompe Disease Hereditary Sensory and Motor Neuropathy Hereditary Spastic Paraplegia Heredodegenerative Disorders, Nervous System Huntington Disease Immune System Diseases Lambert-Eaton Myasthenic Syndrome Mental Disorders Movement Disorders Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Facioscapulohumeral Musculoskeletal Diseases Myasthenia Gravis Myasthenic Syndrome Myotonic Disorders Myotonic Dystrophy Myotonic Dystrophy 1 Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Malformations Nervous System Neoplasms Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Neuromuscular Junction Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity (Disorder) Ocular Motility Disorders Ophthalmoplegia Overnutrition Overweight Paralysis Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Progressive Supranuclear Palsy (PSP) Signs and Symptoms Spastic Paraplegia, Hereditary Spinal Cord Diseases Spinocerebellar Ataxias Spinocerebellar Degenerations Supranuclear Palsy, Progressive Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle

Liège, 4000, Belgium

Location status: Recruiting

Location contact

Laurent Servais, MD

PRINCIPAL_INVESTIGATOR

Nicolas Bovy

CONTACT

[email protected]

+3243218095

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Syde

Device

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.

Dynamometric measurements of muscle strength

Diagnostic Test

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 6-minute walk test (6MWT)

Diagnostic Test

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.

The 10-meter test (10MWT)

Diagnostic 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.

The 4 stair-climbing test (4SC)

Diagnostic 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.

Test of rising from the floor (TRF)

Diagnostic Test

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.

The Timed up and go test (TUG)

Diagnostic Test

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.

The Progressive Supranuclear Palsy Rating Scale (PSP-RS)

Diagnostic Test

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 Montreal Cognitive Assessment (MOCA)

Diagnostic Test

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.

The Charcot-Marie-Tooth examination score (CMTES)

Diagnostic Test

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.

9-Hole Peg Test (9-HPT)

Diagnostic Test

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.

The Unified Huntington's Disease Rating Scale (UHDRS)

Diagnostic Test

This 74-item clinical rating scale assesses patient performance and capacity in 4 domains: motor function, cognitive function, behavioral abnormalities, and functional capacity.

Quantitative Myasthenia Gravis (QMG)

Diagnostic Test

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).

The Myasthenia Gravis Activities of Daily Living Scale (MG-ADL)

Diagnostic Test

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.

The Scale for the Assessment and Rating of Ataxia (SARA)

Diagnostic Test

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.

Patient's Global Impression of Change (PGIC)

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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)

  3. 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)

  4. 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)

  5. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas Bovy

CONTACT

[email protected]

+3243218095

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Liege

Other

Collaborators

  • Centre Hospitalier Régional de la Citadelle
  • SYSNAV

Registry information

Acronym: Acti-Adult

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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