Multiple SclerosisNCT03608527
Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
A study testing Voluntary-based upper limb motor rehabilitation and Passive upper limb mobilization in people with Multiple Sclerosis, run by Fondazione Italiana Sclerosi Multipla.
Trial summary
Motor learning can induce significant changes in the human brain through neural plasticity processes, which play a crucial role in the brain functional reorganization in response to external stimuli and/or to pathological conditions. 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?
- Voluntary-based upper limb motor rehabilitation and Passive upper limb mobilization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 9 Sep 2013to 4 Mar 2015
- 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
- Multiple sclerosis diagnosis according to McDonald criteria
- right handedness as assessed by the Edinburgh Handedness Inventory
- absence of relapses in the last three months
- mild or moderate sensorimotor impairment in one or both upper limbs as evaluated by means of the Medical Research Council scale (grade 3-4)
Who cannot join
- steroid-use or a worsening of the Expanded Disability Status Scale (EDSS) score in the last three months
- psychiatric disorders
- severe cognitive impairment
- magnetic resonance imaging contraindications
About this study
Official title: The Impact of Motor Rehabilitation on the Dynamic Properties of the Brain: Towards the Individual Tailoring of Therapeutic Interventions in Multiple Sclerosis Patients
Motor learning can induce significant changes in the human brain through neural plasticity processes, which play a crucial role in the brain functional reorganization in response to external stimuli and/or to pathological conditions. For example, people with multiple sclerosis present motor deficits often associated with cerebral activity alteration. However, whether these brain activation changes contribute to or protect against motor performance deficits still needs to be determined.
Moreover, rehabilitation protocols could be designed to obtain efficient brain adaptation to preserve patients' outcome, but consistent data on the real efficacy of rehabilitative procedures are lacking, in particular concerning the rehabilitation effect on brain networks.
Therefore, this project focuses on the degree to which imaging measures of functional brain activity can give new hints on the effects of motor rehabilitative protocols in multiple sclerosis patients' performance. Particularly, the investigator's aim is to investigate the effects of upper limb rehabilitation, focused on hand motor function, and the correlation between motor performance and functional magnetic resonance data.
- Conditions
- Multiple Sclerosis
- Being tested
- Voluntary-based upper limb motor rehabilitation, Passive upper limb mobilization
- Keywords
- Upper limb motor rehabilitation, Voluntary movements, functional magnetic resonance imaging
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voluntary-based upper limb motor rehabilitationBehavioural
Exercises for neuromuscular control to improve proprioceptive sensibility, muscle strength, stability and coordination of the upper limbs, mainly including task-oriented movements with the goal to improve activities of daily living. Both proximal and distal muscles are involved, in actions such as grasping wooden cubes of different sizes, pinching, reaching targets displayed in front of the patient, and doing patchwork or paper mandala.
Passive upper limb mobilizationBehavioural
Passive mobilization delivered by a physical therapist of shoulder, elbow, wrist and fingers without detectable muscle activity.
| Study group | Role | What they receive |
|---|---|---|
| Active motor treatment (AMT) group | Experimental | 15 people with multiple sclerosis performing a 8 week rehabilitative treatment based on task-oriented voluntary exercises (3 sessions/week). Receives: Behavioral: Voluntary-based upper limb motor rehabilitation |
| Passive motor treatment (PMT) group | Active comparator | 15 people with multiple sclerosis performing a 8 week passive mobilization delivered by a physical therapist (3 sessions/week). Receives: Behavioral: Passive upper limb mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the time to perform the Nine Hole Peg Test (NHPT)
The NHPT is a brief, standardized, quantitative test of upper extremity function, requiring participants to repeatedly place and then remove nine pegs into nine holes, one at a time, as quickly as possible.
Measured: Baseline and 8 weeks
Secondary outcomes (3)
Score obtained at the Action Research Arm Test (ARAT)
The Action Research Arm Test is an observational measure used to assess upper extremity performance (coordination, dexterity and functioning). The scale ranges from 0 to 57, with higher scores indicating better outcomes. Items are categorized into four subscales: grasp (score 0-18) , grip (0-12), pinch (0-18) and gross movement (0-9) which are arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task.
Measured: Baseline and 8 weeks
Grip and pinch strength
Force applied by the hand and the fingers measured by means of specific dynamometers
Measured: Baseline and 8 weeks
Brain activity (blood-oxygenation-level dependent signal)
Task-related brain activations assessed by means of functional magnetic resonance imaging during a finger-to-thumb opposition sequence
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start9 Sep 2013
- Primary completion22 Dec 2014
- Study completion4 Mar 2015
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.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Sclerosi Multipla
- Sponsor type
- University, hospital or other
- Collaborators
- Universita degli Studi di Genova
- Responsible party
- Sponsor
- Investigators
- Marco Bove, Prof, Principal investigator, Universita degli Studi di Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608527
- Sponsor's protocol ID
- FISM 2011R8
- Status last verified
- Jul 2018
- First submitted
- 13 Jul 2018
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Motor Rehabilitation on the Dynamic Properties of the Brain: Towards the Individual Tailoring of Therapeutic Interventions in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT03608527
- Acronym / sponsor ID
- FISM 2011R8
- Conditions
- Multiple Sclerosis
- Keywords
- Upper limb motor rehabilitation, Voluntary movements, functional magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fondazione Italiana Sclerosi MultiplaUniversity, hospital or other
- Collaborators
- Universita degli Studi di Genova
- Study start
- 9 Sep 2013 (actual)
- Primary completion
- 22 Dec 2014 (actual)
- Study completion
- 4 Mar 2015 (actual)
- First posted
- 1 Aug 2018 (actual)
- 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.
Motor learning can induce significant changes in the human brain through neural plasticity processes, which play a crucial role in the brain functional reorganization in response to external stimuli and/or to pathological conditions. For example, people with multiple sclerosis present motor deficits often associated with cerebral activity alteration. However, whether these brain activation changes contribute to or protect against motor performance deficits still needs to be determined.
Moreover, rehabilitation protocols could be designed to obtain efficient brain adaptation to preserve patients' outcome, but consistent data on the real efficacy of rehabilitative procedures are lacking, in particular concerning the rehabilitation effect on brain networks.
Therefore, this project focuses on the degree to which imaging measures of functional brain activity can give new hints on the effects of motor rehabilitative protocols in multiple sclerosis patients' performance. Particularly, the investigator's aim is to investigate the effects of upper limb rehabilitation, focused on hand motor function, and the correlation between motor performance and functional magnetic resonance data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active motor treatment (AMT) group | Experimental | Behavioral: Voluntary-based upper limb motor rehabilitation15 people with multiple sclerosis performing a 8 week rehabilitative treatment based on task-oriented voluntary exercises (3 sessions/week). |
| Passive motor treatment (PMT) group | Active comparator | Behavioral: Passive upper limb mobilization15 people with multiple sclerosis performing a 8 week passive mobilization delivered by a physical therapist (3 sessions/week). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Multiple sclerosis diagnosis according to McDonald criteria
- right handedness as assessed by the Edinburgh Handedness Inventory
- absence of relapses in the last three months
- mild or moderate sensorimotor impairment in one or both upper limbs as evaluated by means of the Medical Research Council scale (grade 3-4)
Key exclusion criteria (4 listed)
- steroid-use or a worsening of the Expanded Disability Status Scale (EDSS) score in the last three months
- psychiatric disorders
- severe cognitive impairment
- magnetic resonance imaging contraindications
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 |
|---|---|---|
| Voluntary-based upper limb motor rehabilitationExercises for neuromuscular control to improve proprioceptive sensibility, muscle strength, stability and coordination of the upper limbs, mainly including task-oriented movements with the goal to improve activities of daily living. Both proximal and distal muscles are involved, in actions such as grasping wooden cubes of different sizes, pinching, reaching targets displayed in front of the patient, and doing patchwork or paper mandala. | Behavioural | Active motor treatment (AMT) group |
| Passive upper limb mobilizationPassive mobilization delivered by a physical therapist of shoulder, elbow, wrist and fingers without detectable muscle activity. | Behavioural | Passive motor treatment (PMT) group |
Primary outcome
Change in the time to perform the Nine Hole Peg Test (NHPT)
Time frame: Baseline and 8 weeks
The NHPT is a brief, standardized, quantitative test of upper extremity function, requiring participants to repeatedly place and then remove nine pegs into nine holes, one at a time, as quickly as possible.
3 secondary outcomes
Score obtained at the Action Research Arm Test (ARAT)
Time frame: Baseline and 8 weeks
Grip and pinch strength
Time frame: Baseline and 8 weeks
Brain activity (blood-oxygenation-level dependent signal)
Time frame: Baseline and 8 weeks
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 1 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Marco Bove, Prof principal investigator
Universita degli Studi di Genova
Questions about this trial
What is this clinical trial studying?
A study testing Voluntary-based upper limb motor rehabilitation and Passive upper limb mobilization in people with Multiple Sclerosis, run by Fondazione Italiana Sclerosi Multipla.
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 4 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: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in the time to perform the Nine Hole Peg Test (NHPT) (time frame: Baseline and 8 weeks). 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 1 Aug 2018.