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Task-oriented Circuit Class Training in Multiple Sclerosis Subjects

This study is ongoing, but not recruiting participants.
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: June 6, 2013
Last verified: February 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital of Ferrara:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 60
Study Start Date: May 2011
Estimated 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 31, 2011
Last Updated: June 6, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University Hospital of Ferrara:
multiple sclerosis
gait rehabilitation

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

ClinicalTrials.gov processed this record on June 17, 2013