- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04882904
Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects. ActiSLA Part.
Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Laura Buscemi
- Phone Number: 0032 43215584
- Email: Laura.Buscemi@chrcitadelle.be
Study Locations
-
-
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Liège, Belgium, 4000
- Recruiting
- CHR Citadelle
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Contact:
- Laura Buscemi
- Phone Number: 0032 43215584
- Email: Laura.Buscemi@chrcitadelle.be
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patient with ALS
Patient with amyotrophic lateral sclerosis
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
1 year
|
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).
|
1 year
|
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).
|
1 year
|
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).
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Margaux Poleur, MD, CHR Citadelle-CHU liège
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ActiLiège. ActiSLA part.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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