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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Conditions

Neuromuscular Diseases, Obesity (Disorder), Myotonic Dystrophy 1, Myasthenic Syndrome, Charcot Marie Tooth Disease (CMT), Glycogen Storage Disease Type II Pompe Disease

Being tested

Syde, Dynamometric measurements of muscle strength, The 6-minute walk test (6MWT), The 10-meter test (10MWT), The 4 stair-climbing test (4SC)

Medical subject headings

Neuromuscular Diseases, Obesity, Myotonic Dystrophy, Lambert-Eaton Myasthenic Syndrome, Charcot-Marie-Tooth Disease, Muscular Dystrophy, Facioscapulohumeral, Myasthenia Gravis, Huntington Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• SydeDevice

  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 strengthDiagnostic 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: Every 6 months for up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted22 Aug 2025
2. Study start29 Mar 2024
3. Primary completionDec 2029 (estimated)
4. Study completionDec 2030 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.