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Task-oriented Circuit Class Training in Multiple Sclerosis Subjects

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Task-oriented circuit class training
usual care
Sponsored by
University Hospital of Ferrara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, gait rehabilitation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Physical Medicine and Rehabilitation Department Ferrara

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Task-oriented circuit class training

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Feasibility of task-oriented circuit class therapy
It will be performed through the administration of a specific questionnaire

Secondary Outcome Measures

gait speed
10 meter test
mobility
Timed Up and Go
Balance
Dynamic Gait Index
walking endurance
six minute walking test
fatigue
fatigue severity scale
Physical and psychological impact
multiple sclerosis impact scale MSIS-29
Impact on mobility and walking
multiple sclerosis impact scale MSIS-29

Full Information

First Posted
October 31, 2011
Last Updated
April 9, 2014
Sponsor
University Hospital of Ferrara
Collaborators
Università degli Studi di Ferrara
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1. Study Identification

Unique Protocol Identification Number
NCT01464749
Brief Title
Task-oriented Circuit Class Training in Multiple Sclerosis Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Ferrara
Collaborators
Università degli Studi di Ferrara

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, gait rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Task-oriented circuit class training
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Task-oriented circuit class training
Intervention Description
5 sessions/week over 2 weeks (10 sessions) 120 minutes/each
Intervention Type
Behavioral
Intervention Name(s)
usual care
Intervention Description
no specific rehabilitation
Primary Outcome Measure Information:
Title
Feasibility of task-oriented circuit class therapy
Description
It will be performed through the administration of a specific questionnaire
Time Frame
12 months
Secondary Outcome Measure Information:
Title
gait speed
Description
10 meter test
Time Frame
12 months
Title
mobility
Description
Timed Up and Go
Time Frame
12 months
Title
Balance
Description
Dynamic Gait Index
Time Frame
12 months
Title
walking endurance
Description
six minute walking test
Time Frame
12 months
Title
fatigue
Description
fatigue severity scale
Time Frame
12 months
Title
Physical and psychological impact
Description
multiple sclerosis impact scale MSIS-29
Time Frame
12 months
Title
Impact on mobility and walking
Description
multiple sclerosis impact scale MSIS-29
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Physical Medicine and Rehabilitation Department Ferrara
City
Ferrara
State/Province
Emilia Romagna
ZIP/Postal Code
44100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
24906545
Citation
Straudi S, Martinuzzi C, Pavarelli C, Sabbagh Charabati A, Benedetti MG, Foti C, Bonato M, Zancato E, Basaglia N. A task-oriented circuit training in multiple sclerosis: a feasibility study. BMC Neurol. 2014 Jun 7;14:124. doi: 10.1186/1471-2377-14-124.
Results Reference
derived

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Task-oriented Circuit Class Training in Multiple Sclerosis Subjects

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