Task-oriented Circuit Class Training in Multiple Sclerosis Subjects

CompletedNot a drug-phase studyMS (type not specified)NCT01464749

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Task-oriented circuit class training

Compared with

  • usual care

What it measured

Main measures

  • Feasibility of task-oriented circuit class therapy

    12 months

    Feasibility

Other measures (7)

  • gait speed

    12 months

    Walking and mobility
  • mobility

    12 months

    Walking and mobility
  • Balance

    12 months

    Walking and mobility
  • walking endurance

    12 months

    Walking and mobility
  • fatigue

    12 months

    Fatigue
  • Physical and psychological impact

    12 months

    Quality of life (reported by participants)
  • Impact on mobility and walking

    12 months

    Walking and mobilityQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 75 · EDSS 4 to 5

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      May 2011

    2. Main results due

      May 2012

    3. Finished

      Oct 2013

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