Multiple SclerosisNCT02960984
Neurorehabilitation on Upper Limb and on Fatigue in Multiple Sclerosis
A study testing Task Oriented rehabilitation and aerobic training in people with Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
In Multiple Sclerosis the multiplicity of physical and psychological dysfunctions have been shown to exhibit a number of life-altering problems such as fatigue, limb weakness, alteration of upper extremity fine motor coordination, loss of sensation, spasticity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Task Oriented rehabilitation and aerobic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2016to Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Multiple Sclerosis
- no relapses in the last three months
- Expanded Disability Status Scale (EDSS) ≤ 8;
Who cannot join
- subjects with relapses
- worsening of the pathology in the last three months
- subjects with cognitive and psychiatric disturbances
- subjects with cardiovascular disease
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Don Gnocchi ONLUS
Milan, 20148
Davide Cattaneo, PhD
Davide Cattaneo, PhD
About this study
Official title: Effects of Neurorehabilitation on Upper Limb Performance and on Fatigue in People With Multiple Sclerosis
In Multiple Sclerosis the multiplicity of physical and psychological dysfunctions have been shown to exhibit a number of life-altering problems such as fatigue, limb weakness, alteration of upper extremity fine motor coordination, loss of sensation, spasticity. These problems affect performance of many daily living activities (ADL) such as dressing, bathing, self-care, and writing, thus reducing functional independence and self-rated quality of life.
Twenty people with Multiple Sclerosis will receive neurorehabilitation treatment comprising a combination of aerobic training and upper limb task-oriented training.
The aim of this pilot crossover study is to evaluate the effects of neurorehabilitation on upper limb performance and on fatigue in People with Multiple Sclerosis.
- Conditions
- Multiple Sclerosis
- Being tested
- Task Oriented rehabilitation and aerobic training
- 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 rehabilitation and aerobic trainingOther
Participants in the experimental group will receive 1 hour treatment comprising 30' of aerobic training and 30' of task-oriented training focused on uppper limb rehabilitation for 3 times a week for 20 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Neurorehabilitation | Experimental | Participants in the experimental group will receive 1 hour treatment comprising 30' of aerobic training on an ergometer and 30' of task-oriented training focused on uppper limb rehabilitation. Receives: Other: Task Oriented rehabilitation and aerobic training |
| Baseline | No intervention | No intervention is planned |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in 9-hole peg test at 2 and 4 months
Measured: baseline, then participants were followed for the duration the outpatient treatment protocol, an average of 8 weeks, and at follow up 2 months after the end of the treatment protocol
Change from Baseline in Heart Rate at 2 and 4 months
Measured: baseline, then participants were followed for the duration the outpatient treatment protocol, an average of 8 weeks, and at follow up 2 months after the end of the treatment protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- University of Genova
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960984
- Sponsor's protocol ID
- UL_SM
- Status last verified
- Nov 2016
- First submitted
- 8 Nov 2016
- Last updated
- 11 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neurorehabilitation on Upper Limb Performance and on Fatigue in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02960984
- Acronym / sponsor ID
- UL_SM
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- University of Genova
- Study start
- Nov 2016
- Primary completion
- Dec 2017 (estimated)
- First posted
- 10 Nov 2016 (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.
In Multiple Sclerosis the multiplicity of physical and psychological dysfunctions have been shown to exhibit a number of life-altering problems such as fatigue, limb weakness, alteration of upper extremity fine motor coordination, loss of sensation, spasticity. These problems affect performance of many daily living activities (ADL) such as dressing, bathing, self-care, and writing, thus reducing functional independence and self-rated quality of life.
Twenty people with Multiple Sclerosis will receive neurorehabilitation treatment comprising a combination of aerobic training and upper limb task-oriented training.
The aim of this pilot crossover study is to evaluate the effects of neurorehabilitation on upper limb performance and on fatigue in People with Multiple Sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurorehabilitation | Experimental | Other: Task Oriented rehabilitation and aerobic trainingParticipants in the experimental group will receive 1 hour treatment comprising 30' of aerobic training on an ergometer and 30' of task-oriented training focused on uppper limb rehabilitation. |
| Baseline | No intervention | –No intervention is planned |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Multiple Sclerosis
- no relapses in the last three months
- Expanded Disability Status Scale (EDSS) ≤ 8;
Key exclusion criteria (4 listed)
- subjects with relapses
- worsening of the pathology in the last three months
- subjects with cognitive and psychiatric disturbances
- subjects with cardiovascular disease
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 rehabilitation and aerobic trainingParticipants in the experimental group will receive 1 hour treatment comprising 30' of aerobic training and 30' of task-oriented training focused on uppper limb rehabilitation for 3 times a week for 20 sessions. | Other | Neurorehabilitation |
Primary outcome
Change from Baseline in 9-hole peg test at 2 and 4 months
Time frame: baseline, then participants were followed for the duration the outpatient treatment protocol, an average of 8 weeks, and at follow up 2 months after the end of the treatment protocol
Change from Baseline in Heart Rate at 2 and 4 months
Time frame: baseline, then participants were followed for the duration the outpatient treatment protocol, an average of 8 weeks, and at follow up 2 months after the end of the treatment protocol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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.
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 rehabilitation and aerobic training in people with Multiple Sclerosis, run by Fondazione Don Carlo Gnocchi ETS 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Nov 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Davide Cattaneo, PhD (+390240308 ext. 814, dcattaneo@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in 9-hole peg test at 2 and 4 months (time frame: baseline, then participants were followed for the duration the outpatient treatment protocol, an average of 8 weeks, and at follow up 2 months after the end of the treatment protocol). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Nov 2016.