Skip to main content
OpenTrials
Completed

NCT Number: NCT01464749

Task-oriented Circuit Class Training in Multiple Sclerosis Subjects

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Medicine and Rehabilitation Department Ferrara

Ferrara, Emilia-Romagna, 44100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Task-oriented circuit class training

Behavioral

5 sessions/week over 2 weeks (10 sessions) 120 minutes/each

Usual Care

Behavioral

no specific rehabilitation

Primary outcomes

  1. Feasibility of task-oriented circuit class therapy

    Time frame: 12 months

    It will be performed through the administration of a specific questionnaire

Secondary outcomes

  1. gait speed

    Time frame: 12 months

    10 meter test

  2. mobility

    Time frame: 12 months

    Timed Up and Go

  3. Balance

    Time frame: 12 months

    Dynamic Gait Index

  4. walking endurance

    Time frame: 12 months

    six minute walking test

  5. fatigue

    Time frame: 12 months

    fatigue severity scale

  6. Physical and psychological impact

    Time frame: 12 months

    multiple sclerosis impact scale MSIS-29

  7. Impact on mobility and walking

    Time frame: 12 months

    multiple sclerosis impact scale MSIS-29

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Collaborators

  • Università degli Studi di Ferrara

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Nov 3, 2011
Registry last updated
Apr 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.