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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Liege

About this trial

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

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 design

Design model

Single group

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

45 Participants
are divided into 1 treatment group
Group A: Patient with ALSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

95th centile of stride velocity

95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).

Time frame
1 year
2

50th centile of stride velocity

50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).

Time frame
1 year
3

95th centile of stride length

95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).

Time frame
1 year
4

50th centile of stride length

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

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Centre Hospitalier Universitaire de Liege

Lead sponsor

SYSNAV

Collaborator

Centre Hospitalier Régional de la Citadelle

Collaborator