Multiple Sclerosis Clinical Trial
Aims of the study:
This is a single blind randomized-controlled trial to test the feasibility and the effects
of a task oriented training on locomotor function, mobility and balance in multiple
sclerosis subjects with moderate gait impairments (EDSS 4 - 5,5). The control group will not
be treated with a specific physical therapy (usual care).
Subjects and methods:
60 multiple sclerosis patients will be recruited in an outpatient rehabilitation clinic
(Azienda Ospedaliero-Universitaria di Ferrara).
Informed consent will be obtained. Participants will be randomized to (TOCT) task-oriented
training (experimental group) or usual care (control group) through a randomization
stratification approach, according to a block randomization of 6.
The experimental group will receive 10 task-oriented training sessions over 2 weeks (5
sessions/week=intensive training). Three subjects with a supervisor physiotherapist will
take part at the TOCT.
Feasibility outcome will be measured with a specific questionnaire. Treatment efficacy
outcome measures will be clinical test for gait speed (10m walking test), walking endurance
(six minute walking test), balance (Dynamic Gait Index) and mobility (Time Up and Go Test);
a structured interview for the performance(Lower Extremity Mal); self-assessment
questionnaire for motor fatigue (Fatigue Severity Scale FSS), multiple sclerosis physical
and psychological impact (multiple sclerosis impact scale MSIS-29), walking ability
(multiple sclerosis walking scale MSWS-12).
Outcome measures will be assessed the week before the treatment (T0), after the treatment
(T1) and at 3 months follow-up (T2) to evaluate treatments retention, by a clinician blinded
to the treatment.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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