Status:
RECRUITING
Effects of Individualized Training to Reduce Fatigue in Patients With Newly and Advanced Diagnosed Multiple Sclerosis
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Conditions:
Sclerosis
Fatigue
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Multiple sclerosis (MS) is a chronic autoimmune inflammatory disease of the central nervous system. It is characterized by complex and heterogeneous symptoms. Chronic fatigue is the most reported symp...
Detailed Description
The objective of this study will be to investigate the effects of individualized home-training, guided by a mobile application, to reduce fatigue in patients with newly (N) and advanced (A) diagnosed ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Relapsing-remitting MS (RRMS) defined according to the criteria of McDonald
- MS diagnosed less than 2 years ago or whose first symptoms are estimated to be less than 5 years old OR MS diagnosed more than 2 years ago and whose first symptoms are estimated to be less than 5 years old
- With a high level of fatigue, corresponding to an FSS score \> 4
- Expanded Disability Status Scale (EDSS) score \< 4
- Medical Research Council (MRC) testing ≥ 4 in all leg muscles
- Ability to walk for 10 minutes without stopping (self-reported)
- Have a mobile phone with internet access
- Affiliated with or benefiting from a social security scheme
- Have freely given their written consent after being informed of the aim, the procedure and the potential risks involved
- Exclusion criteria
- Spasticity or severe cerebellar ataxia in either leg.
- Abnormal range of movement of the toes and/or ankle
- Musculoskeletal injury that impairs pedalling
- Appearance of a multiple sclerosis attack in the 90 days preceding the study
- Recent adjustment of any medication or drug that may have an impact on fatigue: treatment of neuropathic pain: anti-epileptic and/or taking stimulants for fatigue (e.g. modafinil, amantadine, fampridine...)
- History of comorbid illness or conditions that would compromise the subject's safety during the study
- Participation at the same time in another medical intervention study or having participated in such a study in the 30 days prior to this study
- Pregnant and breast-feeding women
- Patients who are unable to understand the purpose of the study and the conditions under which it will be conducted, or who are unable to give their consent.
- Patients deprived of their liberty or under guardianship
Exclusion
Key Trial Info
Start Date :
September 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2025
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06201026
Start Date
September 12 2023
End Date
September 15 2025
Last Update
October 23 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chu de Saint-Etienne
Saint-Etienne, France, 42055