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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04882904
• Other study ID #: ActiLiège. ActiSLA part.
• Status: Recruiting
• Phase: N/A
• Start date: September 25, 2020
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Liege
• Contact: Laura Buscemi
• Phone: 43215584
• Email: Laura.Buscemi[@]chrcitadelle.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Intervention

Device:
• Actimyo°
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.

Locations

Country	Name	City	State
Belgium	CHR Citadelle	Liège

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Liege	Centre Hospitalier Régional de la Citadelle, SYSNAV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	95th centile of stride velocity	95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).	1 year
Primary	50th centile of stride velocity	50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).	1 year
Primary	95th centile of stride length	95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).	1 year
Primary	50th centile of stride length	50th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).	1 year
Secondary	Upper limb function evolution in patient with ALS	Upper limb function assessed with a magneto-inertial sensor (Actimyo°) in real-life.	1 year