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

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

Interventions

DEVICE

Syde

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.

DIAGNOSTIC_TEST

Dynamometric measurements of muscle strength

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.

DIAGNOSTIC_TEST

The 6-minute walk test (6MWT)

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.

DIAGNOSTIC_TEST

The 10-meter test (10MWT)

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.

DIAGNOSTIC_TEST

The 4 stair-climbing test (4SC)

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.

DIAGNOSTIC_TEST

Test of rising from the floor (TRF)

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.

DIAGNOSTIC_TEST

The Timed up and go test (TUG)

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.

DIAGNOSTIC_TEST

The Progressive Supranuclear Palsy Rating Scale (PSP-RS)

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.

DIAGNOSTIC_TEST

The Montreal Cognitive Assessment (MOCA)

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.

DIAGNOSTIC_TEST

The Charcot-Marie-Tooth examination score (CMTES)

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.

DIAGNOSTIC_TEST

9-Hole Peg Test (9-HPT)

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.

DIAGNOSTIC_TEST

The Unified Huntington's Disease Rating Scale (UHDRS)

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

DIAGNOSTIC_TEST

Quantitative Myasthenia Gravis (QMG)

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).

DIAGNOSTIC_TEST

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

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.

DIAGNOSTIC_TEST

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

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.

OTHER

Patient's Global Impression of Change (PGIC)

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.

Sponsors & Collaborators

• Centre Hospitalier Régional de la Citadelle

  collaborator OTHER

• SYSNAV

  collaborator INDUSTRY

• Centre Hospitalier Universitaire de Liege

  lead OTHER

Principal Investigators

• Laurent Servais, MD · Centre Hospitalier Universitaire de Liege

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-29

Primary Completion

2029-12-31

Completion

2030-12-31

Countries

• Belgium

Study Locations