Clinical trial NCT02421744: A Task-oriented Circuit Training in Multiple Sclerosis
Official title: A Task-oriented Circuit Training in Multiple Sclerosis: a Multicentric Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: rehabilitation
Multiple Sclerosis
mobility
gait
task-oriented training
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* males and females,
* community dwelling,
* age \>18 and \<75
* diagnosis of multiple sclerosis in a stable phase, with relapses \> 3 months prior to study enrollment
* moderate gait impairments referred to Expanded Disability Status Scale (EDSS) between 4 and 5,5
* MMSE \>24

Exclusion Criteria:

* neurologic conditions in addition to multiple sclerosis that may affect motor function
* medical conditions likely to interfere with the ability to safely complete the study
* pregnancy

Primary outcomes:
measure: Six-Minute Walking Test
timeFrame: Weeks: 0,2,14, 26
Secondary outcomes:
measure: Timed 25-Foot walk (25FWT)
timeFrame: weeks: 0,2,14, 26
measure: Time Up and Go Test
timeFrame: weeks: 0,2,14, 26
measure: Dynamic Gait Index (DGI)
timeFrame: weeks: 0,2,14, 26
measure: Modified fatigue impact scale (MFIS)
timeFrame: weeks: 0,2,14, 26
measure: Multiple Sclerosis Walking Scale - 12 (MSWS-12)
timeFrame: weeks: 0,2,14, 26
measure: Multiple Sclerosis Impact Scale- 29 (MSIS-29)
timeFrame: weeks: 0,2,14, 26
measure: Functional Assessment of Multiple Sclerosis (FAMS)
timeFrame: weeks: 0,2,14, 26
measure: Metabolic cerebral measurements by Near infrared spectroscopy
timeFrame: weeks: 0,2,14, 26
measure: Postural sway (Center of pressure (COP) trajectories)
timeFrame: weeks: 0,2,14, 26
measure: Force and EMG signal (perform an isometric extension of the knees on an isokinetic dynamometer (PrimusRS BTETM Technology), achieving their own Maximum Voluntary Contraction (MVC)
timeFrame: weeks: 0,2,14, 26
measure: Mechanical and electrical fatigue assessment (evaluated measuring sustained contractions in isometric tasks in lower limbs on an isokinetic dynamometer (PrimusRS BTETM Technology)
timeFrame: weeks: 0,2,14, 26
measure: Brain plasticity and connectivity (High density EEG and vertical electrooculogram (EOG) will be recorded with a standard bipolar 64-channels montage and a DC-coupled amplifier (Micromed SD MRI, System Plus acquisition software)
timeFrame: weeks: 0,2,14, 26
measure: Metabolic muscular measurements by Near infrared spectroscopy
timeFrame: weeks: 0,2,14, 26
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Ferrara University Hospital
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
Study officials:
affiliation: Ferrara Rehabilitation Hospital
name: Sofia Straudi, MD
role: PRINCIPAL_INVESTIGATOR
References: