Holter of Movement in Patients With Multiple Sclerosis in Uncontrolled Environment.
Primary Purpose
Multiple Sclerosis
Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Actimyo
Sponsored by
About this trial
This is an interventional diagnostic trial for Multiple Sclerosis focused on measuring Actimyo, Accelerometry, Home monitoring
Eligibility Criteria
Inclusion Criteria:
- Confirmed MS diagnosis,
- Over 18 years old,
- Ambulant patients,
- Signed informed consent,
- No clinical and / or radiological relapse within 3 months.
- EDSS < or = à 5,5,
- Treated patient must be on a stable regimen dose and molecule for at least 2 month prior to inclusion.
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
Sites / Locations
- Centre Hospitalier Universitaire de Liège
- CHR Citadelle
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MS patients
Arm Description
Ambulant patients with multiple 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).
Stance phase time
Stance time over full stride time for each foot obtained with a magneto-inertial sensor (Actimyo°) in real-life (percentage).
Secondary Outcome Measures
Full Information
NCT ID
NCT04882891
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
NCT04882891
Brief Title
Holter of Movement in Patients With Multiple Sclerosis in Uncontrolled Environment.
Official Title
Holter of Movement in Patients With Multiple Sclerosis. Acti-SEP Study: Uncontrolled Environment.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 9, 2021 (Actual)
Primary Completion Date
February 15, 2026 (Anticipated)
Study Completion Date
February 15, 2026 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
ActiSEP is a multicentric academic study. Ambulant patients with multiple sclerosis may be included on a voluntary basis. The investigators plan to include a group of approximately 80 patients with MS, fulfilling the McDonald's 2017 criteria, of whom 40 of them show a progressive course according to the Lublin classification.
The investigators have planned two visits (at baseline and 1 year later). On both visits, participants will perform few tests (timed 25-Foot Walk (T25-FW), 9-Hole Peg Test (9-HPG), 6-minutes walk test (6MWT), Berg balance scale) and will answer to some questionaires (Godin Leisure Time Exercice Questionnaire, multiple sclerosis walking scale, modified fatigue impact scale, Hospital Anxiety and Depression Scale) After each visit, participants will wear Actimyo for three months in daily living.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Actimyo, Accelerometry, Home monitoring
7. Study Design
Primary Purpose
Diagnostic
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 assess their gait and its evolution.
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MS patients
Arm Type
Experimental
Arm Description
Ambulant patients with multiple 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
Title
Stance phase time
Description
Stance time over full stride time for each foot obtained with a magneto-inertial sensor (Actimyo°) in real-life (percentage).
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed MS diagnosis,
Over 18 years old,
Ambulant patients,
Signed informed consent,
No clinical and / or radiological relapse within 3 months.
EDSS < or = à 5,5,
Treated patient must be on a stable regimen dose and molecule for at least 2 month prior to inclusion.
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
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
Centre Hospitalier Universitaire de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHR Citadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Holter of Movement in Patients With Multiple Sclerosis in Uncontrolled Environment.
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