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: February 27, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	October 31, 2011
Last Updated Date	February 27, 2013
Start Date ^ICMJE	May 2011
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 2, 2011)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01464749 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 2, 2011)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Task-oriented Circuit Class Training in Multiple Sclerosis Subjects
Official Title ^ICMJE	Not Provided
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Multiple Sclerosis
Intervention ^ICMJE	Behavioral: Task-oriented circuit class training 5 sessions/week over 2 weeks (10 sessions) 120 minutes/each Behavioral: usual care no specific rehabilitation
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	60
Estimated Completion Date	October 2013
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01464749
Other Study ID Numbers ^ICMJE	TOCT
Has Data Monitoring Committee	Yes
Responsible Party	Sofia Straudi, MD, University Hospital of Ferrara
Study Sponsor ^ICMJE	University Hospital of Ferrara
Collaborators ^ICMJE	Università degli Studi di Ferrara
Investigators ^ICMJE	Not Provided
Information Provided By	University Hospital of Ferrara
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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