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Holter of Movement in Patients With Amyotrophic Lateral Sclerosis. (ActiALS)

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ClinicalTrials.gov Identifier: NCT06228001
Recruitment Status : Recruiting
First Posted : January 29, 2024
Last Update Posted : April 26, 2024
Sponsor:
Collaborators:
SYSNAV
Centre Hospitalier Régional de la Citadelle
Information provided by (Responsible Party):
Laurent Servais, Centre Hospitalier Universitaire de Liege

Tracking Information
First Submitted Date December 14, 2023
First Posted Date January 29, 2024
Last Update Posted Date April 26, 2024
Actual Study Start Date May 1, 2023
Estimated Primary Completion Date January 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 18, 2024)
  • Difference in 95th centile of stride velocity between baseline and one year follow up- or last time point [ Time Frame: 1 year ]
    95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
  • Difference in 50th centile of stride velocity between baseline and one year follow up- or last time point [ Time Frame: 1 year ]
    50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter per second).
  • Difference in 95th centile of stride length between baseline and one year follow up- or last time point [ Time Frame: 1 year ]
    95th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).
  • Difference in 50th centile of stride length between baseline and one year follow up- or last time point [ Time Frame: 1 year ]
    50th centile of stride length obtained with a magneto-inertial sensor (Actimyo°) in real-life (meter).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 18, 2024)		 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Holter of Movement in Patients With Amyotrophic Lateral Sclerosis.
Official Title Holter of Movement in Patients 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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients diagnosed with amyotrophic lateral sclerosis
Condition Amyotrophic Lateral Sclerosis
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 18, 2024)		 30
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2028
Estimated Primary Completion Date January 2028   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Laura Buscemi +3243215584 laura.buscemi@citadelle.be
Contact: Margaux Poleur, MD +3243216127 margaux.poleur@citadelle.be
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT06228001
Other Study ID Numbers ActiALS study
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Laurent Servais, Centre Hospitalier Universitaire de Liege
Original Responsible Party Dr. Stéphanie Delstanche, Centre Hospitalier Régional de la Citadelle, Head of reference center for neuromuscular diseases
Current Study Sponsor Laurent Servais
Original Study Sponsor Dr. Stéphanie Delstanche
Collaborators
  • SYSNAV
  • Centre Hospitalier Régional de la Citadelle
Investigators
Principal Investigator: Stéphanie Delstanche, MD Centre de référence des maladies neuromusculaire, Centre Hospitalier Régional de la Citadelle
PRS Account Centre Hospitalier Universitaire de Liege
Verification Date April 2024