Multiple Sclerosis Clinical Trial
Official title:
A Task-oriented Circuit Training in Multiple Sclerosis: a Multicentric Randomized Controlled Trial
Verified date | May 2017 |
Source | University Hospital of Ferrara |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | October 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Ferrara University Hospital | Ferrara | |
Italy | Azienda Ospedaliera Universitaria Pisana | Pisa |
Lead Sponsor | Collaborator |
---|---|
University Hospital of Ferrara |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Six-Minute Walking Test | The walking endurance is measured with the Six-Minute Walking Test. Subjects are instructed to walk up and down as far as possible a 22m walkway in six minutes, with the possibility to slow down and rest if necessary. | Weeks: 0,2,14, 26 | |
Secondary | Timed 25-Foot walk (25FWT) | a quantitative measure of lower extremity function, also included in the Multiple Sclerosis Functional Composite (MSFC) . The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet (7.62m) as quickly as possible, but safely, using the prescribed assistive devices. The task is immediately administered again by having the patient walk back the same distance. Test will be performed according to the instructions reported on the manual of the National Multiple Sclerosis Society . | weeks: 0,2,14, 26 | |
Secondary | Time Up and Go Test | Subjects will be given verbal instruction to stand up from a chair, walk 3 meters, cross a line marked on the floor, turn around, walk back, and sit down. A study staff member will guard the subject during the test. Subjects will perform 3 trials and the time it takes to perform each trial will be recorded with a stopwatch. | weeks: 0,2,14, 26 | |
Secondary | Dynamic Gait Index (DGI) | Assesses individual's ability to modify balance while walking in the presence of external demands | weeks: 0,2,14, 26 | |
Secondary | Modified fatigue impact scale (MFIS) | The MFIS is a modified form of the Fatigue Impact Scale (Fisk et al, 1994) based on items derived from interviews with MS patients concerning how fatigue impacts their lives. This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. | weeks: 0,2,14, 26 | |
Secondary | Multiple Sclerosis Walking Scale - 12 (MSWS-12) | The 12-item multiple sclerosis walking scale (MSWS-12) is a self-report measure of the impact of MS on the individual's walking ability. | weeks: 0,2,14, 26 | |
Secondary | Multiple Sclerosis Impact Scale- 29 (MSIS-29) | This is an health-rated quality of life questionnaire that assesses the impact of MS on physical and psychological functions. It is formed by 29 items on ADL I and II: 20 about physical activity and 9 of psychological status of the person. Each item can be scored with a value from 0 to 5; total score is given by the sum of all the items and then is transformed in a range from 0 to 100. A higher value correspond to a worse perception of subject's HRQoL. | weeks: 0,2,14, 26 | |
Secondary | Functional Assessment of Multiple Sclerosis (FAMS) | Quality of life instrument of for use in people with MS. Consists of 59 items (44 of which are scored) in six quality of life domains. Higher scores indicate better quality of life. | weeks: 0,2,14, 26 | |
Secondary | Metabolic cerebral measurements by Near infrared spectroscopy | Near InfraRed Spectroscopy (NIRS) is a noninvasive, portable technique for ambulatory or remote monitoring of human motor-cortex oxygenation changes in response to motor tasks. Patients will walk on the treadmill at a speed of 0.2 km/h assisted by personnel and with partial body weight support, performing 4 short tasks (30 seconds of walking) alternated by rest periods (30 seconds). | weeks: 0,2,14, 26 | |
Secondary | Postural sway (Center of pressure (COP) trajectories) | Center of pressure (COP) trajectories | weeks: 0,2,14, 26 | |
Secondary | 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) | Patients will perform an isometric extension of the knees on an isokinetic dynamometer (PrimusRS BTETM Technology), achieving their own Maximum Voluntary Contraction (MVC) during a set of 3 seconds trials. | weeks: 0,2,14, 26 | |
Secondary | Mechanical and electrical fatigue assessment (evaluated measuring sustained contractions in isometric tasks in lower limbs on an isokinetic dynamometer (PrimusRS BTETM Technology) | Muscle fatigue will be evaluated measuring sustained contractions in isometric tasks in lower limbs on an isokinetic dynamometer (PrimusRS BTETM Technology), maintaining a MVC for knee and ankle extension for 60 s. | weeks: 0,2,14, 26 | |
Secondary | 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) | 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). | weeks: 0,2,14, 26 | |
Secondary | Metabolic muscular measurements by Near infrared spectroscopy | Noninvasive muscle measurements will be performed at gastrocnemius by an optical imaging system consisting of 2 light source fibers and 2 detector fibers. | weeks: 0,2,14, 26 |
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