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Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects. ActiSLA Part.

NCT04882904 · Centre Hospitalier Universitaire de Liege
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Official title
Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects
About this study
ActiSLA is a monocentric academic study. Patients with amyotrophic lateral sclerosis may be included on a voluntary basis. The investigators plan to include a group of approximately 20 patients with ALS. The investigators have planned to assess patient every three months for a year. On each visit, participants will undergo a clinical examination with MRC sum score and Ashworth scores. They will perform few tests ( 6-minutes walk test (6MWT), dynamometric measure, electromyography, Edinburgh Cognitive and Behavioural ALS Screen ) and will answer to some questionaires (dysphagia handicap scale, ALS-SFR-r). After each visit, participants will wear Actimyo for one month daily.
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: 45 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2020-09-25
Estimated completion: 2026-12
Last updated: 2025-12-05
Interventions
Device: Actimyo°
Primary outcomes
  • 95th centile of stride velocity (1 year)
  • 50th centile of stride velocity (1 year)
  • 95th centile of stride length (1 year)
Sponsor
Centre Hospitalier Universitaire de Liege · other
With: SYSNAV, Centre Hospitalier Régional de la Citadelle
Contacts & investigators
ContactLaurie MEDARD · contact · Laurie.Medard@citadelle.be · 43218222
InvestigatorMargaux Poleur, MD · principal_investigator, CHR Citadelle-CHU liège
All locations (1)
CHR CitadelleRecruiting
Liège, Liège, Belgium
Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects. ActiSLA Part. · TrialPath