Task-oriented Circuit Class Training in Multiple Sclerosis Subjects
|ClinicalTrials.gov Identifier: NCT01464749|
Recruitment Status : Completed
First Posted : November 3, 2011
Last Update Posted : April 10, 2014
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 or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Behavioral: Task-oriented circuit class training Behavioral: usual care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||October 2013|
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
- Feasibility of task-oriented circuit class therapy [ Time Frame: 12 months ]It will be performed through the administration of a specific questionnaire
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464749
|Physical Medicine and Rehabilitation Department Ferrara|
|Ferrara, Emilia Romagna, Italy, 44100|