Clinical trial NCT06228001: Holter of Movement in Patients With Amyotrophic Lateral Sclerosis.
Official title: Holter of Movement in Patients With Amyotrophic Lateral Sclerosis.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Actimyo
Accelerometry
Daily living
Lead sponsor: Centre Hospitalier Universitaire de Liege
Sponsor class: OTHER
Collaborators: name: SYSNAV
First posted: 2024-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with amyotrophic lateral sclerosis

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Difference in 95th centile of stride velocity between baseline and one year follow up- or last time point
timeFrame: 1 year
measure: Difference in 50th centile of stride velocity between baseline and one year follow up- or last time point
timeFrame: 1 year
measure: Difference in 95th centile of stride length between baseline and one year follow up- or last time point
timeFrame: 1 year
measure: Difference in 50th centile of stride length between baseline and one year follow up- or last time point
timeFrame: 1 year
Secondary outcomes:
measure: Upper limb function evolution in patient with ALS
timeFrame: 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven
city: Liège
country: Belgium
facility: Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle
city: Cairo
country: Egypt
facility: Galaa Military Medical Complex
Study officials:
affiliation: Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle
name: Stéphanie Delstanche, MD
role: PRINCIPAL_INVESTIGATOR
References: