Holter of Movement in Patients With Amyotrophic Lateral Sclerosis.

Amyotrophic Lateral Sclerosis Clinical Trial

— ActiALS  

Official title:

Holter of Movement in Patients With Amyotrophic Lateral Sclerosis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06228001
• Other study ID #: ActiALS study
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: January 2028

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Liege
• Contact: Laura Buscemi
• Phone: +3243215584
• Email: laura.buscemi[@]citadelle.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

ActiALS is a multicentric academic study. Patients with amyotrophic lateral sclerosis (ALS) may be included on a voluntary basis. The investigators plan to include a group of approximately 30 patients with ALS. The investigators have planned to assess patient every three months for a year. After each visit, participants will wear Actimyo for one month daily.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

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
• Sclerosis

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	Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle	Liège

Sponsors (3)

Lead Sponsor	Collaborator
Laurent Servais	Centre Hospitalier Régional de la Citadelle, SYSNAV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in 95th centile of stride velocity between baseline and one year follow up- or last time point	95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).	1 year
Primary	Difference in 50th centile of stride velocity between baseline and one year follow up- or last time point	50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).	1 year
Primary	Difference in 95th centile of stride length between baseline and one year follow up- or last time point	95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).	1 year
Primary	Difference in 50th centile of stride length between baseline and one year follow up- or last time point	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