Multiple Sclerosis
Conditions
Keywords
multiple sclerosis, gait rehabilitation
Brief summary
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.
Interventions
BEHAVIORALTask-oriented circuit class training
5 sessions/week over 2 weeks (10 sessions) 120 minutes/each
BEHAVIORALusual care
no specific rehabilitation
Sponsors
Università degli Studi di Ferrara
University Hospital of Ferrara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* males and females, * community dwelling, * age 18 or older * 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
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 * impaired cognitive functioning: Mini Mental Status Examination \< 24
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of task-oriented circuit class therapy | 12 months | It will be performed through the administration of a specific questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mobility | 12 months | Timed Up and Go |
| Balance | 12 months | Dynamic Gait Index |
| walking endurance | 12 months | six minute walking test |
| gait speed | 12 months | 10 meter test |
| Physical and psychological impact | 12 months | multiple sclerosis impact scale MSIS-29 |
| Impact on mobility and walking | 12 months | multiple sclerosis impact scale MSIS-29 |
| fatigue | 12 months | fatigue severity scale |
Countries
Italy
Outcome results
None listed