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Task-oriented Circuit Class Training in Multiple Sclerosis Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01464749
First Posted: November 3, 2011
Last Update Posted: April 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Università degli Studi di Ferrara
Information provided by (Responsible Party):
Sofia Straudi, MD, University Hospital of Ferrara
  Purpose

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.


Condition Intervention
Multiple Sclerosis Behavioral: Task-oriented circuit class training Behavioral: usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sofia Straudi, MD, University Hospital of Ferrara:

Primary Outcome Measures:
  • Feasibility of task-oriented circuit class therapy [ Time Frame: 12 months ]
    It will be performed through the administration of a specific questionnaire


Secondary Outcome Measures:
  • gait speed [ Time Frame: 12 months ]
    10 meter test

  • mobility [ Time Frame: 12 months ]
    Timed Up and Go

  • Balance [ Time Frame: 12 months ]
    Dynamic Gait Index

  • walking endurance [ Time Frame: 12 months ]
    six minute walking test

  • fatigue [ Time Frame: 12 months ]
    fatigue severity scale

  • Physical and psychological impact [ Time Frame: 12 months ]
    multiple sclerosis impact scale MSIS-29

  • Impact on mobility and walking [ Time Frame: 12 months ]
    multiple sclerosis impact scale MSIS-29


Enrollment: 24
Study Start Date: May 2011
Study Completion Date: October 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Behavioral: Task-oriented circuit class training
5 sessions/week over 2 weeks (10 sessions) 120 minutes/each
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.
Behavioral: usual care
no specific rehabilitation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464749


Locations
Italy
Physical Medicine and Rehabilitation Department Ferrara
Ferrara, Emilia Romagna, Italy, 44100
Sponsors and Collaborators
University Hospital of Ferrara
Università degli Studi di Ferrara
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sofia Straudi, MD, Physical Medicine and Rehabilitation doctor, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT01464749     History of Changes
Other Study ID Numbers: Multiple Sclerosis TOCT
First Submitted: October 31, 2011
First Posted: November 3, 2011
Last Update Posted: April 10, 2014
Last Verified: April 2014

Keywords provided by Sofia Straudi, MD, University Hospital of Ferrara:
multiple sclerosis
gait rehabilitation

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases