Health TrialsbyHealthPanel

Holter of Movement in Patients With Amyotrophic Lateral Sclerosis.

ConditionAmyotrophic Lateral Sclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Liege

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Patients diagnosed with amyotrophic lateral sclerosis

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Actimyo

    Device

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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).

Time frame
1 year
2

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).

Time frame
1 year
3

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).

Time frame
1 year
4

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).

Time frame
1 year

Secondary outcomes

1

Upper limb function evolution in patient with ALS

Upper limb function assessed with a magneto-inertial sensor (Actimyo°) in real-life.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire de Liege

Lead sponsor

SYSNAV

Collaborator

Source ClinicalTrials.gov
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