Multiple Sclerosis Subjects Clinical Trial
Official title:
The Effects of a Task-oriented Circuit Training Combined With Cerebellar Transcranial Direct Current Stimulation on Locomotor Function, Balance and Mobility in Multiple Sclerosis Subjects
Aims of the study:
This is a double-blind randomized-controlled trial to test the effects of a task oriented
training combined with cerebellar transcranial direct current stimulation on locomotor
function, mobility and balance in multiple sclerosis subjects with moderate gait impairments
(EDSS 4-5,5).
Subjects and methods: 30 multiple sclerosis patients will be recruited in an outpatient
rehabilitation clinic University Hospital Ferrara. Informed consent will be obtained.
Participants enrolled will included in 2 different treatment groups: Task Oriented Circuit
Training (TOCT) + anodal cerebellar transcranial direct current stimulation (experimental
group) and TOCT + sham transcranial direct current stimulation over the cerebellum (control
group). The group with anodal transcranial direct current stimulation will receive continuous
stimulation with intensity of 2 mA during the first 15 minutes of functional circuit
training. In the sham session, anodal transcranial direct current stimulation was applied for
30 s and then shut off. Each subject will receive 10 task-oriented training sessions over 2
weeks (5 sessions/week). 3 subjects with a supervisor physiotherapist will take part at the
TOCT. During the stimulation sessions both the subject and the researcher, responsible for
carrying out clinical tests, will be unaware of the type of stimulation set.
Treatment efficacy outcome measures will be clinical test for gait speed (Timed 25-Foot
Walk), walking endurance (six minute walking test), balance (Dynamic Gait Index) and mobility
(Time Up and Go Test); self-assessment questionnaire for motor fatigue (Fatigue Severity
Scale FSS) and quality of life (Short Form (36) Health Survey).
Outcome measures will be assessed the week prior to treatment initiation (T0), the week after
the end of treatment (T1) and at 3 months follow-up (T3) to evaluate treatments retention, by
a clinician blinded to the treatment. At the end of each session, the subject will complete a
questionnaire where report side effects due to stimulation (headache, neck pain, burning,
redness and/or itching in the site of stimulation).
The inclusion criteria will be:
- males and females, community dwelling, age 18 or older;
- diagnosis of multiple sclerosis in a stable phase, which will be defined as a chronic
progressive or relapsing-remitting pattern with no relapse during the last 3 months;
- moderate gait impairments referred to Expanded Disability Status Scale between 4 and 5,5
(this EDSS scores refers to people with restricted ambulation who do not need walking
aids).
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