Task-oriented Circuit Class Training in Multiple Sclerosis Subjects

This study has been completed.
Sponsor:
Collaborator:
Università degli Studi di Ferrara
Information provided by (Responsible Party):
Sofia Straudi, MD, University Hospital of Ferrara
ClinicalTrials.gov Identifier:
NCT01464749
First received: October 31, 2011
Last updated: April 9, 2014
Last verified: April 2014

October 31, 2011
April 9, 2014
May 2011
May 2012   (final data collection date for primary outcome measure)
Feasibility of task-oriented circuit class therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
It will be performed through the administration of a specific questionnaire
Same as current
Complete list of historical versions of study NCT01464749 on ClinicalTrials.gov Archive Site
  • gait speed [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    10 meter test
  • mobility [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Timed Up and Go
  • Balance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Dynamic Gait Index
  • walking endurance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    six minute walking test
  • fatigue [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    fatigue severity scale
  • Physical and psychological impact [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    multiple sclerosis impact scale MSIS-29
  • Impact on mobility and walking [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    multiple sclerosis impact scale MSIS-29
Same as current
Not Provided
Not Provided
 
Task-oriented Circuit Class Training in Multiple Sclerosis Subjects
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Multiple Sclerosis
  • Behavioral: Task-oriented circuit class training
    5 sessions/week over 2 weeks (10 sessions) 120 minutes/each
  • Behavioral: usual care
    no specific rehabilitation
  • Experimental: Task-oriented circuit class training

    Functional Circuit include 6 different work-stations in which patients exercise for 5 minutes in each one : 3 minutes exercises and 2 minutes rest. Total training takes about 30 minutes (2 laps/session over 60 minutes).

    Walking endurance is trained by 30 minutes walking on the treadmill including rests if necessary.

    It is a progressive circuit and subjects, while exercising, receives feedback (visual and auditory) by the physiotherapist. Rests are used to discuss about difficulties and to provide further feedbacks. One task oriented session may include up to 3 patients and lasts 120 minutes. At the end of the 2 weeks an exercises brochure will be given to patients so that they can independently train for 3 month. Independent home training takes about 90 minutes.

    Intervention: Behavioral: Task-oriented circuit class training
  • Active Comparator: Usual Care
    The control group will not receive any specific rehabilitation treatment for gait performance and mobility improvement (usual care). At any case, the control group will be authorized, at will, to exercise in non-rehabilitative contexts (i.e. swimming, walking, yoga) or do physical rehabilitation in rehabilitative gyms not directly addressed to gait, mobility or balance training such as stretching exercises, active and passive mobilization and Bobath neurorehabilitation or similar.
    Intervention: Behavioral: usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
October 2013
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01464749
Multiple Sclerosis TOCT
Yes
Sofia Straudi, MD, University Hospital of Ferrara
University Hospital of Ferrara
Università degli Studi di Ferrara
Not Provided
University Hospital of Ferrara
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP