Clinical trial NCT01464749: Task-oriented Circuit Class Training in Multiple Sclerosis Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
gait rehabilitation
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
Collaborators: name: Università degli Studi di Ferrara
First posted: 2011-11-03
Enrollment: 24
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: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of task-oriented circuit class therapy
timeFrame: 12 months
Secondary outcomes:
measure: gait speed
timeFrame: 12 months
measure: mobility
timeFrame: 12 months
measure: Balance
timeFrame: 12 months
measure: walking endurance
timeFrame: 12 months
measure: fatigue
timeFrame: 12 months
measure: Physical and psychological impact
timeFrame: 12 months
measure: Impact on mobility and walking
timeFrame: 12 months
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Physical Medicine and Rehabilitation Department Ferrara
state: Emilia Romagna
Study officials:
References:
citation: Straudi S, Martinuzzi C, Pavarelli C, Sabbagh Charabati A, Benedetti MG, Foti C, Bonato M, Zancato E, Basaglia N. A task-oriented circuit training in multiple sclerosis: a feasibility study. BMC Neurol. 2014 Jun 7;14:124. doi: 10.1186/1471-2377-14-124.