Relapsing-remitting Multiple SclerosisEarly Phase 1NCT01040117
Sensori-motor Integration Training in Multiple Sclerosis
A Early Phase 1 study testing Sensory-motor Integration Training and Conventional neurorehabilitation treatment in people with Relapsing-remitting Multiple Sclerosis, run by Universita di Verona at 2 sites in Italy.
Trial summary
Balance impairment is a common and very disabling disturbance in people with Multiple Sclerosis. The efficacy of pharmacotherapy in treating balance impairment in MS is poorly documented in literature. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis
- What is being tested?
- Sensory-motor Integration Training and Conventional neurorehabilitation treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesItaly
- Study dates
- Dec 2009to Jan 2012
- Phase
- Early Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age < 65 years
- Expanded Disability Status Scale (EDSS) 2.0 > score < 6.0 (24)
- Mini Mental State Evaluation (MMSE) score ≥ 24
- Absence of cognitive impairment
- Absence of heart problems
- Self-reported sensation of postural instability
- Ability to maintain standing position without aids for at least 1 minute
- Ability to walk independently for at least 15 metres
Who cannot join
- Disease recurrence that worsens significantly during the 3 months prior to recruitment
- Pharmacological therapy not well defined
- Presence of vestibular disorders and/or paroxysmal vertigo
- Performance of any type of rehabilitation treatment in the month prior to recruitment
- Presence of other concurrent neurological or orthopaedic diseases involving the lower limbs and/or interfering with standing position and/or walking.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
S.S.O. di Riabilitazione dell'Ospedale Policlinico
Verona, Verona, 37126
Section of Clinical Neurology, Department Neurological, Neuropsychological, Morphological and Movement Sciences, University of Verona, Verona, Italy
Verona, 37124
About this study
Official title: Effects of Sensori-motor Integration Balance Training on Balance Disturbances in Patients With Multiple Sclerosis
Balance impairment is a common and very disabling disturbance in people with Multiple Sclerosis. The efficacy of pharmacotherapy in treating balance impairment in MS is poorly documented in literature. Although literature dealing with the rehabilitation of balance impairment in MS is very scant, the preliminary data reports show very promising results. The present project could have a positive impact on balance and gait ability, disability, fear of falling, risk of falls and quality of life of patients with Multiple Sclerosis.
Read the detailed description
Balance impairment is one of the primary causes of disability in people with multiple sclerosis (MS). It increases the risk of falls and contributes to the development of fear of falling (FOF), a vicious cycle that leads to a limitation in daily life activities. The imbalance could be caused by motor and sensorial deficits as well as sensory-motor integration deficits. Despite the disability that balance disorders cause, literature about its' rehabilitation is very scant. To our knowledge two studies have been published on MS balance rehabilitation. The first paper described case reports on MS balance rehabilitation using the "Bobath" approach. The second paper performed a preliminary randomized controlled study describing the effectiveness in restoring balance control and reducing risk of falling using a specific training program aimed at improving sensory-motor integration in people with MS. Considering the several limitations of this study, further trials are warranted to assess the usefulness of specific sensory-motor training on balance impairment in people with MS. The aim of this randomised controlled double blinded clinical trial is to evaluate whether a training program consisting of exercises performed under different sensory conflict conditions can lead to an improvement in postural stability in patients with MS. This in turn might lead to an improvement in walking ability, autonomy in daily life activities and quality of life in people with MS.
The study will include 80 patients (age<65 years) with a diagnosis of MS relapsing remitted according to the McDonald criteria and with an Expanded Disability Status Scale score≤6.0. Patients will be divided into 2 groups, according to a randomization design. The experimental group will undergo a specific training program aimed at increasing balance ability in several sensory conflict conditions. The training program will consist of fifteen 50-minute sessions over a 5 week period (3 sessions/week). The control group will undergo conventional neurorehabilitation treatment following the same pattern of sessions as the study group. At recruitment, after treatment (5 weeks) and in the follow-up (1 month), each patient will be tested with the following clinical and instrumental procedures: Berg Balance Scale, Activities-specific Balance Confidence Scale, Fatigue Severity Scale, Postural Transfers evaluation, Multiple Sclerosis Quality Of Life (MSQOL)-54 instrument, Sensory Organization Test, GAITRite® System and platform stabilometry.
Data will be examined at first reassessment for between group differences. Data from the second reassessment will be analysed for within group differences. Sample characteristics will be summarised using descriptive statistics. Due to the small sample size, non-parametric tests will be applied: Wilcoxon's signed ranks test for within group comparisons and the Mann-withney U test for between group comparisons, both with significance set at p=0.05. Data will be analysed using SPSS v16 software.
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Being tested
- Sensory-motor Integration Training, Conventional neurorehabilitation treatment
- Keywords
- Equilibrium, Rehabilitation, Randomized Controlled Trial, Postural instability, Sensory-motor integration
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory-motor Integration TrainingProcedure or surgery
Exercises will be divided into 3 levels. 1 Starting from the patient's most stable and comfortable standing position. 2 Patient will perform a single-step simulation, shifting his/her weight from one foot to the other in a frontal direction. 3 Patient will perform rapid movements, alternating feet in many directions, progressively increasing weight shifting and decreasing the support base amplitude. In the first five sessions exercises will be performed on a stable surface. During the remaining sessions patients will perform exercises on a compliant surface. During the two training periods the patient's visual condition will be progressively changed.
Conventional neurorehabilitation treatmentProcedure or surgery
The treatment will be consist in active joint mobilization, muscle stretching and strengthen and motor coordination exercises. In the first part of each session the active joint mobilization will be carried out while the patient was lying on a carpet in supine, prone. The training will continue with muscle stretching and strengthen exercises performed while patient will be in supine, prone (when possible) and standing.
Motor coordination exercises will be carried out in supine position while sitting on a bench and in the standing position with a front support or with against a wall. The patient will be required to performed a total of 10 exercises with the following sequence: 6 exercises in supine position, 2 exercises in sitting position and 2 in standing position.
| Study group | Role | What they receive |
|---|---|---|
| Sensory-motor Integration Training | Experimental | Not described Receives: Procedure: Sensory-motor Integration Training |
| Conventional neurorehabilitation | Active comparator | Not described Receives: Procedure: Conventional neurorehabilitation treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment procedures: - Berg Balance Scale (BBS) - Activities-specific Balance Confidence Scale (ABC) Instrumental assessment procedures: - Stabilometric assessment
Measured: At recruitment, after treatment (5 weeks) and in the follow-up (1 month)
Secondary outcomes (1)
Clinical evaluation - Walking evaluation - Multiple Sclerosis Quality Of Life-54 (MSQOL-54) - Fatigue Severity Scale (FSS) - Postural Transfers
Measured: At recruitment, after treatment (5 weeks) and in the follow-up (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionOct 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Relapsing-remitting 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Smania, Universita di Verona
- Investigators
- Antonio Fiaschi, Professor, Study chair, Department of Neurological and Visual Sciences, University of Verona, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040117
- Sponsor's protocol ID
- FISM-2009
- Other IDs
- 2009/R/27
- Status last verified
- Mar 2012
- First submitted
- 28 Dec 2009
- Last updated
- 15 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Smania N, Picelli A, Gandolfi M, Fiaschi A, Tinazzi M. Rehabilitation of sensorimotor integration deficits in balance impairment of patients with stroke hemiparesis: a before/after pilot study. Neurol Sci. 2008 Oct;29(5):313-9. doi: 10.1007/s10072-008-0988-0. Epub 2008 Oct 21.
PubMed 18941933Cattaneo D, Jonsdottir J. Sensory impairments in quiet standing in subjects with multiple sclerosis. Mult Scler. 2009 Jan;15(1):59-67. doi: 10.1177/1352458508096874. Epub 2008 Oct 9.
PubMed 18845654Cattaneo D, Jonsdottir J, Zocchi M, Regola A. Effects of balance exercises on people with multiple sclerosis: a pilot study. Clin Rehabil. 2007 Sep;21(9):771-81. doi: 10.1177/0269215507077602.
PubMed 17875557Gandolfi M, Munari D, Geroin C, Gajofatto A, Benedetti MD, Midiri A, Carla F, Picelli A, Waldner A, Smania N. Sensory integration balance training in patients with multiple sclerosis: A randomized, controlled trial. Mult Scler. 2015 Oct;21(11):1453-62. doi: 10.1177/1352458514562438. Epub 2015 Jan 12.
PubMed 25583852
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sensori-motor Integration Balance Training on Balance Disturbances in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01040117
- Acronym / sponsor ID
- FISM-2009
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Keywords
- Equilibrium, Rehabilitation, Randomized Controlled Trial, Postural instability, Sensory-motor integration
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 29 Dec 2009 (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.
Balance impairment is a common and very disabling disturbance in people with Multiple Sclerosis. The efficacy of pharmacotherapy in treating balance impairment in MS is poorly documented in literature. Although literature dealing with the rehabilitation of balance impairment in MS is very scant, the preliminary data reports show very promising results. The present project could have a positive impact on balance and gait ability, disability, fear of falling, risk of falls and quality of life of patients with Multiple Sclerosis.
Detailed description
Balance impairment is one of the primary causes of disability in people with multiple sclerosis (MS). It increases the risk of falls and contributes to the development of fear of falling (FOF), a vicious cycle that leads to a limitation in daily life activities. The imbalance could be caused by motor and sensorial deficits as well as sensory-motor integration deficits. Despite the disability that balance disorders cause, literature about its' rehabilitation is very scant. To our knowledge two studies have been published on MS balance rehabilitation. The first paper described case reports on MS balance rehabilitation using the "Bobath" approach. The second paper performed a preliminary randomized controlled study describing the effectiveness in restoring balance control and reducing risk of falling using a specific training program aimed at improving sensory-motor integration in people with MS. Considering the several limitations of this study, further trials are warranted to assess the usefulness of specific sensory-motor training on balance impairment in people with MS. The aim of this randomised controlled double blinded clinical trial is to evaluate whether a training program consisting of exercises performed under different sensory conflict conditions can lead to an improvement in postural stability in patients with MS. This in turn might lead to an improvement in walking ability, autonomy in daily life activities and quality of life in people with MS.
The study will include 80 patients (age<65 years) with a diagnosis of MS relapsing remitted according to the McDonald criteria and with an Expanded Disability Status Scale score≤6.0. Patients will be divided into 2 groups, according to a randomization design. The experimental group will undergo a specific training program aimed at increasing balance ability in several sensory conflict conditions. The training program will consist of fifteen 50-minute sessions over a 5 week period (3 sessions/week). The control group will undergo conventional neurorehabilitation treatment following the same pattern of sessions as the study group. At recruitment, after treatment (5 weeks) and in the follow-up (1 month), each patient will be tested with the following clinical and instrumental procedures: Berg Balance Scale, Activities-specific Balance Confidence Scale, Fatigue Severity Scale, Postural Transfers evaluation, Multiple Sclerosis Quality Of Life (MSQOL)-54 instrument, Sensory Organization Test, GAITRite® System and platform stabilometry.
Data will be examined at first reassessment for between group differences. Data from the second reassessment will be analysed for within group differences. Sample characteristics will be summarised using descriptive statistics. Due to the small sample size, non-parametric tests will be applied: Wilcoxon's signed ranks test for within group comparisons and the Mann-withney U test for between group comparisons, both with significance set at p=0.05. Data will be analysed using SPSS v16 software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensory-motor Integration Training | Experimental | Procedure: Sensory-motor Integration Training |
| Conventional neurorehabilitation | Active comparator | Procedure: Conventional neurorehabilitation treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age < 65 years
- Expanded Disability Status Scale (EDSS) 2.0 > score < 6.0 (24)
- Mini Mental State Evaluation (MMSE) score ≥ 24
- Absence of cognitive impairment
- Absence of heart problems
Key exclusion criteria (5 listed)
- Disease recurrence that worsens significantly during the 3 months prior to recruitment
- Pharmacological therapy not well defined
- Presence of vestibular disorders and/or paroxysmal vertigo
- Performance of any type of rehabilitation treatment in the month prior to recruitment
- Presence of other concurrent neurological or orthopaedic diseases involving the lower limbs and/or interfering with standing position and/or walking.
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 |
|---|---|---|
| Sensory-motor Integration TrainingExercises will be divided into 3 levels. 1 Starting from the patient's most stable and comfortable standing position. 2 Patient will perform a single-step simulation, shifting his/her weight from one foot to the other in a frontal direction. 3 Patient will perform rapid movements, alternating feet in many directions, progressively increasing weight shifting and decreasing the support base amplitude. In the first five sessions exercises will be performed on a stable surface. During the remaining sessions patients will perform exercises on a compliant surface. During the two training periods the patient's visual condition will be progressively changed. | Procedure or surgery | Sensory-motor Integration Training |
| Conventional neurorehabilitation treatmentThe treatment will be consist in active joint mobilization, muscle stretching and strengthen and motor coordination exercises. In the first part of each session the active joint mobilization will be carried out while the patient was lying on a carpet in supine, prone. The training will continue with muscle stretching and strengthen exercises performed while patient will be in supine, prone (when possible) and standing. Motor coordination exercises will be carried out in supine position while sitting on a bench and in the standing position with a front support or with against a wall. The patient will be required to performed a total of 10 exercises with the following sequence: 6 exercises in supine position, 2 exercises in sitting position and 2 in standing position. | Procedure or surgery | Conventional neurorehabilitation |
Primary outcome
Clinical assessment procedures: - Berg Balance Scale (BBS) - Activities-specific Balance Confidence Scale (ABC) Instrumental assessment procedures: - Stabilometric assessment
Time frame: At recruitment, after treatment (5 weeks) and in the follow-up (1 month)
1 secondary outcome
Clinical evaluation - Walking evaluation - Multiple Sclerosis Quality Of Life-54 (MSQOL-54) - Fatigue Severity Scale (FSS) - Postural Transfers
Time frame: At recruitment, after treatment (5 weeks) and in the follow-up (1 month)
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 15 Mar 2012.
- Background: PubMed 18941933Smania N, Picelli A, Gandolfi M, Fiaschi A, Tinazzi M. Rehabilitation of sensorimotor integration deficits in balance impairment of patients with stroke hemiparesis: a before/after pilot study. Neurol Sci. 2008 Oct;29(5):313-9. doi: 10.1007/s10072-008-0988-0. Epub 2008 Oct 21.
- Background: PubMed 18845654Cattaneo D, Jonsdottir J. Sensory impairments in quiet standing in subjects with multiple sclerosis. Mult Scler. 2009 Jan;15(1):59-67. doi: 10.1177/1352458508096874. Epub 2008 Oct 9.
- Background: PubMed 17875557Cattaneo D, Jonsdottir J, Zocchi M, Regola A. Effects of balance exercises on people with multiple sclerosis: a pilot study. Clin Rehabil. 2007 Sep;21(9):771-81. doi: 10.1177/0269215507077602.
- Derived from this study: PubMed 25583852Gandolfi M, Munari D, Geroin C, Gajofatto A, Benedetti MD, Midiri A, Carla F, Picelli A, Waldner A, Smania N. Sensory integration balance training in patients with multiple sclerosis: A randomized, controlled trial. Mult Scler. 2015 Oct;21(11):1453-62. doi: 10.1177/1352458514562438. Epub 2015 Jan 12.
- The website of the Italian Foundation of Multiple SclerosisLink provided by the sponsor.
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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.
Antonio Fiaschi, Professor study chair
Department of Neurological and Visual Sciences, University of Verona, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sensory-motor Integration Training and Conventional neurorehabilitation treatment in people with Relapsing-remitting Multiple Sclerosis, run by Universita di Verona at 2 sites 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 8 inclusion and 5 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 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical assessment procedures: - Berg Balance Scale (BBS) - Activities-specific Balance Confidence Scale (ABC) Instrumental assessment procedures: - Stabilometric assessment (time frame: At recruitment, after treatment (5 weeks) and in the follow-up (1 month)). 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 NCT01040117, which also lists 4 linked publications.
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 15 Mar 2012.