RecruitingRecruiting
Holter of Movement in Patients With Amyotrophic Lateral Sclerosis.
NCT06228001 · Centre Hospitalier Universitaire de Liege
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
On each visit, participants will undergo a clinical examination with MRC sum score and Ashworth scores.
Participants will perform few tests (6-minutes walk test (6MWT), dynamometric measure, electromyography, and will answer to some questionaires (dysphagia handicap scale, Revised Amyotrophic Lateral Sclerosis Functional Rating Scale).
Actimyo 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.
Eligibility criteria
Inclusion Criteria:
* Clinically defined or probable diagnosis of ALS according to El Escorial criteria revised with Awaji's electro-diagnostic algorithm.
* Over 18 years old.
* Signed informed consent
* If patient on Riluzole, the dosage should be stable for 1 month and continued throughout the study period.
Exclusion Criteria:
* Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection.
* Any other previous or present pathology having an impact on motor function.
* Recent surgery or trauma (less than 6 months) in the upper or lower limbs.
* Prior neurological, endocrine, infectious, allergic, or chronic or acute inflammatory pathology in the three weeks preceding inclusion.
* Patients participating in an interventional clinical trial.
Study design
Enrollment target: 30 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-05-01
Estimated completion: 2028-01
Last updated: 2025-05-19
Interventions
Device: Actimyo
Primary outcomes
- • Difference in 95th centile of stride velocity between baseline and one year follow up- or last time point (1 year)
- • Difference in 50th centile of stride velocity between baseline and one year follow up- or last time point (1 year)
- • Difference in 95th centile of stride length between baseline and one year follow up- or last time point (1 year)
Sponsor
Centre Hospitalier Universitaire de Liege · other
With: SYSNAV
Contacts & investigators
ContactLaurie Medard · contact · laurie.medard@citadelle.be · +3243218222
ContactMargaux Poleur, MD · contact · margaux.poleur@citadelle.be · +3243216127
InvestigatorStéphanie Delstanche, MD · principal_investigator, Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle
All locations (3)
Katholieke Universiteit LeuvenRecruiting
Leuven, Belgium
Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la CitadelleRecruiting
Liège, Belgium
Galaa Military Medical ComplexActive Not Recruiting
Cairo, Egypt