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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status

Recruiting

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Actimyo°

About this trial

This is an interventional other trial for Amyotrophic Lateral Sclerosis focused on measuring Actimyo, Accelerometry, Daily living

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CHR CitadelleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient with ALS

Arm Description

Patient with amyotrophic lateral sclerosis

Outcomes

Primary Outcome Measures

95th centile of stride velocity

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

50th centile of stride velocity

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

95th centile of stride length

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

50th centile of stride length

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

Secondary Outcome Measures

Upper limb function evolution in patient with ALS

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

Full Information

NCT ID

NCT04882904

First Posted

March 11, 2021

Last Updated

October 6, 2023

Sponsor

Dr. Stéphanie Delstanche

Collaborators

Sysnav, Centre Hospitalier Universitaire de Liege

1. Study Identification

Unique Protocol Identification Number

NCT04882904

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 25, 2020 (Actual)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr. Stéphanie Delstanche

Collaborators

Sysnav, Centre Hospitalier Universitaire de Liege

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis

Keywords

Actimyo, Accelerometry, Daily living

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

All patients undergo clinical evaluation and wear Actimyo device in daily living to evaluate their evolution.

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patient with ALS

Arm Type

Experimental

Arm Description

Patient with amyotrophic lateral sclerosis

Intervention Type

Device

Intervention Name(s)

Actimyo°

Intervention Description

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 Measure Information:

Title

95th centile of stride velocity

Description

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

Time Frame

1 year

Title

50th centile of stride velocity

Description

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

Time Frame

1 year

Title

95th centile of stride length

Description

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

Time Frame

1 year

Title

50th centile of stride length

Description

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Upper limb function evolution in patient with ALS

Description

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

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Laura Buscemi

Phone

43215584

Ext

0032

Laura.Buscemi@chrcitadelle.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Margaux Poleur, MD

Organizational Affiliation

CHR Citadelle-CHU liège

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHR Citadelle

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laura Buscemi

Phone

43215584

Ext

0032

Laura.Buscemi@chrcitadelle.be

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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