Task-oriented Circuit Class Training in Multiple Sclerosis Subjects

Multiple Sclerosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01464749
• Other study ID #: Multiple Sclerosis TOCT
• Status: Completed
• Phase: N/A
• First received: October 31, 2011
• Last updated: April 9, 2014
• Start date: May 2011
• Est. completion date: October 2013

Study information

• Verified date: April 2014
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Italy	Physical Medicine and Rehabilitation Department Ferrara	Ferrara	Emilia Romagna

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of Ferrara	Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of task-oriented circuit class therapy	It will be performed through the administration of a specific questionnaire	12 months	No
Secondary	gait speed	10 meter test	12 months	No
Secondary	mobility	Timed Up and Go	12 months	No
Secondary	Balance	Dynamic Gait Index	12 months	No
Secondary	walking endurance	six minute walking test	12 months	No
Secondary	fatigue	fatigue severity scale	12 months	No
Secondary	Physical and psychological impact	multiple sclerosis impact scale MSIS-29	12 months	No
Secondary	Impact on mobility and walking	multiple sclerosis impact scale MSIS-29	12 months	No