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

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ClinicalTrials.gov Identifier: NCT04882904
Recruitment Status : Recruiting
First Posted : May 12, 2021
Last Update Posted : May 12, 2021
Sponsor:
Collaborators:
Sysnav
Centre Hospitalier Universitaire de Liège
Information provided by (Responsible Party):
Dr. Stéphanie Delstanche, Centre Hospitalier Régional de la Citadelle

Brief Summary:

ActiSEP 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 45 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.


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Device: Actimyo° Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All patients undergo clinical evaluation and wear Actimyo device in daily living to evaluate their evolution.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects
Actual Study Start Date : September 25, 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023


Arm Intervention/treatment
Experimental: Patient with ALS
Patient with amyotrophic lateral sclerosis
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.




Primary Outcome Measures :
  1. 95th centile of stride velocity [ Time Frame: 1 year ]
    95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).

  2. 50th centile of stride velocity [ Time Frame: 1 year ]
    50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).

  3. 95th centile of stride length [ Time Frame: 1 year ]
    95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).

  4. 50th centile of stride length [ Time Frame: 1 year ]
    50th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).


Secondary Outcome Measures :
  1. Upper limb function evolution in patient with ALS [ Time Frame: 1 year ]
    Upper limb function assessed with a magneto-inertial sensor (Actimyo°) in real-life.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04882904


Contacts
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Contact: Laura Buscemi 43215584 ext 0032 Laura.Buscemi@chrcitadelle.be

Locations
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Belgium
CHR Citadelle Recruiting
Liège, Belgium, 4000
Contact: Laura Buscemi    43215584 ext 0032    Laura.Buscemi@chrcitadelle.be   
Sponsors and Collaborators
Dr. Stéphanie Delstanche
Sysnav
Centre Hospitalier Universitaire de Liège
Investigators
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Principal Investigator: Margaux Poleur, MD CHR Citadelle-CHU liège
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Responsible Party: Dr. Stéphanie Delstanche, Coordinator of reference center for neuromuscular diseases, Centre Hospitalier Régional de la Citadelle
ClinicalTrials.gov Identifier: NCT04882904    
Other Study ID Numbers: ActiLiège. ActiSLA part.
First Posted: May 12, 2021    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Stéphanie Delstanche, Centre Hospitalier Régional de la Citadelle:
Actimyo
Accelerometry
Daily living
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases