Physical Medicine and Rehabilitation Department Ferrara
Ferrara, Emilia-Romagna, 44100, Italy
NCT Number: NCT01464749
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.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Ferrara, Emilia-Romagna, 44100, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5 sessions/week over 2 weeks (10 sessions) 120 minutes/each
no specific rehabilitation
Time frame: 12 months
It will be performed through the administration of a specific questionnaire
Time frame: 12 months
10 meter test
Time frame: 12 months
Timed Up and Go
Time frame: 12 months
Dynamic Gait Index
Time frame: 12 months
six minute walking test
Time frame: 12 months
fatigue severity scale
Time frame: 12 months
multiple sclerosis impact scale MSIS-29
Time frame: 12 months
multiple sclerosis impact scale MSIS-29
University Hospital of Ferrara
Other
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