Multiple SclerosisNCT01464749
Task-oriented Circuit Class Training in Multiple Sclerosis Subjects
A study testing Task-oriented circuit class training in people with Multiple Sclerosis, run by University Hospital of Ferrara at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Task-oriented circuit class training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- May 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Physical Medicine and Rehabilitation Department Ferrara
Ferrara, Emilia-Romagna, 44100
About this study
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).
Read more
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Task-oriented circuit class training, usual care
- Keywords
- multiple sclerosis, gait rehabilitation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-oriented circuit class trainingBehavioural
5 sessions/week over 2 weeks (10 sessions) 120 minutes/each
usual careBehavioural
no specific rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Task-oriented circuit class training | Experimental | 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. Receives: Behavioral: Task-oriented circuit class training |
| Usual Care | Active comparator | 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. Receives: Behavioral: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of task-oriented circuit class therapy
It will be performed through the administration of a specific questionnaire
Measured: 12 months
Secondary outcomes (7)
gait speed
10 meter test
Measured: 12 months
mobility
Timed Up and Go
Measured: 12 months
Balance
Dynamic Gait Index
Measured: 12 months
walking endurance
six minute walking test
Measured: 12 months
fatigue
fatigue severity scale
Measured: 12 months
Physical and psychological impact
multiple sclerosis impact scale MSIS-29
Measured: 12 months
Impact on mobility and walking
multiple sclerosis impact scale MSIS-29
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Ferrara
- Responsible party
- Principal investigator, Sofia Straudi, MD, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464749
- Sponsor's protocol ID
- Multiple Sclerosis TOCT
- Status last verified
- Apr 2014
- First submitted
- 31 Oct 2011
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24906545
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task-oriented Circuit Class Training in Multiple Sclerosis Subjects
- ClinicalTrials.gov ID
- NCT01464749
- Acronym / sponsor ID
- Multiple Sclerosis TOCT
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, gait rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Collaborators
- Università degli Studi di Ferrara
- Study start
- May 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 3 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Task-oriented circuit class training | Experimental | Behavioral: Task-oriented circuit class trainingFunctional 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. |
| Usual Care | Active comparator | Behavioral: usual careThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Task-oriented circuit class training5 sessions/week over 2 weeks (10 sessions) 120 minutes/each | Behavioural | Task-oriented circuit class training |
| usual careno specific rehabilitation | Behavioural | Usual Care |
Primary outcome
Feasibility of task-oriented circuit class therapy
Time frame: 12 months
It will be performed through the administration of a specific questionnaire
7 secondary outcomes
gait speed
Time frame: 12 months
mobility
Time frame: 12 months
Balance
Time frame: 12 months
walking endurance
Time frame: 12 months
fatigue
Time frame: 12 months
Physical and psychological impact
Time frame: 12 months
Impact on mobility and walking
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
- Derived from this study: PubMed 24906545Straudi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task-oriented circuit class training in people with Multiple Sclerosis, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of task-oriented circuit class therapy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01464749, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2014.