A Task-oriented Circuit Training in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Our primary hypothesis is that a two weeks high-intensity task-oriented circuit training
      followed by a structured 3 months home exercise program would have higher benefits compared
      to a delayed-treatment group as control in people with multiple sclerosis and mild to
      moderate gait impairment.

      Our secondary hypothesis is that there could be retention of clinical gains in subjects that
      underwent TOCT plus structured 3 months home exercise program.
    

Detailed description: 
      This is a single blind randomized-controlled trial to test the effects of a task oriented
      training on locomotor function, mobility and balance in multiple sclerosis subjects with mild
      to moderate gait impairments (EDSS 4-5.5).

      Subjects and methods:54 multiple sclerosis patients will be recruited in two outpatient
      rehabilitation clinics (Azienda Ospedaliero- Universitaria di Ferrara and Azienda
      Ospedaliero-Universitaria Pisana). Informed consent will be obtained. Participants enrolled
      will be included in 2 different treatment groups: experimental group will receive 10 TOCT
      sessions over 2 weeks (2 hours/each session) followed by a 3 months home exercise program,
      whereas control group will be included into a delayed-treatment group. Three subjects with a
      supervisor physiotherapist will take part at the TOCT. Primary outcome measure will be
      walking endurance (Six Minute Walking Test); as secondary outcome we will test gait speed
      (Timed 25-Foot Walk), balance (Dynamic Gait Index) and mobility (Time Up and Go Test);
      through self-assessment questionnaires we will evaluate motor fatigue (Modified Fatigue
      Impact Scale - MFIS), walking ability (Multiple Sclerosis Walking Scale - 12), health-related
      quality of life (Multiple Sclerosis Impact Scale - 29 and Functional Assessment of Multiple
      Sclerosis). In addition to clinical outcomes, in a convenience sample we will have: (i)
      balance assessment (force platform); (ii) motorcortex oxygenation during walking (fNIRS);
      (iii) muscle oxygenation (NIRS); (iv) force and EMG signal; (v) mechanical and electrical
      fatigue assessment; (vi) brain connectivity (EEG). Outcome measures will be assessed 1 week
      prior to treatment initiation (T0), after two weeks to treatment initiation (T1), after the 3
      months exercise program (T2) and at 3 months follow-up (T3) to evaluate treatments retention,
      by a clinician blinded to the treatment.

      The specific aims will be (i) to test the effects on walking, mobility, balance, fatigue and
      health-related quality of life; (ii) to test the effects on cerebral oxygenation (fNIRS)
      during walking; (iii) muscle oxygenation (NIRS); (iv) force and EMG signal; (v) Mechanical
      and electrical fatigue assessment; (vi) brain connectivity (EEG) and (vii) to investigate the
      3 months home exercise program's feasibility, satisfaction and adherence.
    

Intervention name(s): Task Oriented Circuit Training; Delayed Onset TOCT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): TOCT includes six different workstations in which subjects exercise for 5 minutes in each one (3 minutes of exercise and 2 minutes of rest). During each session, subjects undergo 2 laps that take about 60 minutes (6 workstation × 5 minutes × 2 laps), with 10 minutes of rest after each lap. In addition, walking endurance is trained by 30 minutes walking on the treadmill including rests if necessary. This is a progressive circuit and subjects while exercising receive feedbacks (visual and auditory) by the physiotherapist. Rests are used to discuss about difficulties and to provide further feedbacks. One session includes up to 3 patients and lasts 120 minutes, 5 days/week for 2 weeks. After this period they will receive a home-exercise maintenance program for 3 months.; The control group will not receive any specific rehabilitation treatment for gait performance and mobility improvement. At any case, the control group will be authorized, at will, to exercise in non-rehabilitative contexts (i.e. swimming, walking, yoga) for 14 weeks. After this period they will receive TOCT as treatment plus a home-exercise maintenance program for 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: rehabilitation; Multiple Sclerosis; mobility; gait; task-oriented training