NCT01464749

Task-oriented Circuit Class Training in Multiple Sclerosis Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University Hospital of Ferrara · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
BEHAVIORAL	Task-oriented circuit class training	5 sessions/week over 2 weeks (10 sessions) 120 minutes/each
BEHAVIORAL	usual care	no specific rehabilitation

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-05-01
• Completion: 2013-10-01
• First posted: 2011-11-03
• Last updated: 2014-04-10

Locations

1 site across 1 country: Italy