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

NCT07136844 | Recruiting

• 1 other identifier: ActiLiège Adult
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 95th Centile of Stride Velocity (SV95C)

  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 Outcomes (5)

• Device Acceptability and Adherence

  Over 2 years

• Correlation between Syde® and 6MWT

  Every 6 months for up to 2 years

• Correlation between Syde® and 10MWT

  Every 6 months for up to 2 years

• Correlation between Syde® and 4SC

  Every 6 months for up to 2 years

• Correlation between Syde® and TRF

  Every 6 months for up to 2 years

Study Arms (8)

Neuromuscular condition - Muscle disease

EXPERIMENTAL

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)

Neuromuscular condition - Neuropathy

EXPERIMENTAL

Device: Syde; Diagnostic Test: Dynamometric measurements of muscle strength; 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); Diagnostic Test: The Charcot-Marie-Tooth examination score (CMTES); Diagnostic Test: 9-Hole Peg Test (9-HPT); Other: Patient's Global Impression of Change (PGIC)

Ataxia

EXPERIMENTAL

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); Diagnostic Test: 9-Hole Peg Test (9-HPT); Diagnostic Test: The Scale for the Assessment and Rating of Ataxia (SARA); Other: Patient's Global Impression of Change (PGIC)

Huntington disease (HD) and HD-like

EXPERIMENTAL

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); Diagnostic Test: The Unified Huntington's Disease Rating Scale (UHDRS); Other: Patient's Global Impression of Change (PGIC)

Progressive supranuclear palsy (PSP) and PSP-like

EXPERIMENTAL

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); Diagnostic Test: The Timed up and go test (TUG); Diagnostic Test: The Progressive Supranuclear Palsy Rating Scale (PSP-RS); Diagnostic Test: The Montreal Cognitive Assessment (MOCA); Other: Patient's Global Impression of Change (PGIC)

Spastic paraplesia and conditions where spasticity predominates, incl. stroke

EXPERIMENTAL

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)

Obese patients

EXPERIMENTAL

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)

Neuromuscular condition - Neuromuscular Junction

EXPERIMENTAL

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); Diagnostic Test: Quantitative Myasthenia Gravis (QMG); Diagnostic Test: The Myasthenia Gravis Activities of Daily Living Scale (MG-ADL); Other: Patient's Global Impression of Change (PGIC)

Interventions

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.

Ataxia; Huntington disease (HD) and HD-like; Neuromuscular condition - Muscle disease; Neuromuscular condition - Neuromuscular Junction; Neuromuscular condition - Neuropathy; Obese patients; Progressive supranuclear palsy (PSP) and PSP-like; Spastic paraplesia and conditions where spasticity predominates, incl. stroke

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.

Neuromuscular condition - Neuropathy

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.

Ataxia; Huntington disease (HD) and HD-like; Neuromuscular condition - Muscle disease; Neuromuscular condition - Neuromuscular Junction; Neuromuscular condition - Neuropathy; Obese patients; Progressive supranuclear palsy (PSP) and PSP-like; Spastic paraplesia and conditions where spasticity predominates, incl. stroke

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.

Ataxia; Huntington disease (HD) and HD-like; Neuromuscular condition - Muscle disease; Neuromuscular condition - Neuromuscular Junction; Neuromuscular condition - Neuropathy; Obese patients; Progressive supranuclear palsy (PSP) and PSP-like; Spastic paraplesia and conditions where spasticity predominates, incl. stroke

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.

Ataxia; Huntington disease (HD) and HD-like; Neuromuscular condition - Muscle disease; Neuromuscular condition - Neuromuscular Junction; Neuromuscular condition - Neuropathy; Obese patients; Progressive supranuclear palsy (PSP) and PSP-like; Spastic paraplesia and conditions where spasticity predominates, incl. stroke

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.

Ataxia; Huntington disease (HD) and HD-like; Neuromuscular condition - Muscle disease; Neuromuscular condition - Neuromuscular Junction; Neuromuscular condition - Neuropathy; Obese patients; Progressive supranuclear palsy (PSP) and PSP-like; Spastic paraplesia and conditions where spasticity predominates, incl. stroke

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.

Progressive supranuclear palsy (PSP) and PSP-like

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.

Progressive supranuclear palsy (PSP) and PSP-like

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.

Progressive supranuclear palsy (PSP) and PSP-like

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.

Neuromuscular condition - 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.

Ataxia; Neuromuscular condition - Neuropathy

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.

Huntington disease (HD) and HD-like

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).

Neuromuscular condition - Neuromuscular Junction

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.

Neuromuscular condition - Neuromuscular Junction

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.

Ataxia

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.

Ataxia; Huntington disease (HD) and HD-like; Neuromuscular condition - Muscle disease; Neuromuscular condition - Neuromuscular Junction; Neuromuscular condition - Neuropathy; Obese patients; Progressive supranuclear palsy (PSP) and PSP-like; Spastic paraplesia and conditions where spasticity predominates, incl. stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Signed informed consent form by patient him/herself and patient willing and able to comply with all study procedures.

You may not qualify if:

• 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
• Patients who are participating in an interventional clinical trial
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Liege: lead
• Centre Hospitalier Régional de la Citadelle: collaborator
• SYSNAV: collaborator

Study Sites (1)

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

Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Neuromuscular Diseases; Obesity; Myotonic Dystrophy; Lambert-Eaton Myasthenic Syndrome; Charcot-Marie-Tooth Disease; Muscular Dystrophy, Facioscapulohumeral; Myasthenia Gravis; Huntington Disease; Supranuclear Palsy, Progressive; Spastic Paraplegia, Hereditary; Spinocerebellar Ataxias

Interventions

Walk Test

Condition Hierarchy (Ancestors)

Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Myotonic Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Neuromuscular Junction Diseases; Autoimmune Diseases; Immune System Diseases; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Polyneuropathies; Peripheral Nervous System Diseases; Congenital Abnormalities; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Cerebellar Ataxia; Cerebellar Diseases; Spinocerebellar Degenerations; Spinal Cord Diseases; Ataxia

Intervention Hierarchy (Ancestors)

Exercise Test; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Laurent Servais, MD

  Centre Hospitalier Universitaire de Liege

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Bovy

CONTACT

+3243218095; Nicolas.Bovy@citadelle.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Pediatrician

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 22, 2025
• Study Start: March 29, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)