Sensori-motor Integration Training in Multiple Sclerosis
Primary Purpose
Relapsing-remitting Multiple Sclerosis
Status
Completed
Phase
Early Phase 1
Locations
Italy
Study Type
Interventional
Intervention
Sensory-motor Integration Training
Conventional neurorehabilitation treatment
Sponsored by
About this trial
This is an interventional treatment trial for Relapsing-remitting Multiple Sclerosis focused on measuring Equilibrium, Rehabilitation, Randomized Controlled Trial, Postural instability, Sensory-motor integration
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Section of Clinical Neurology, Department Neurological, Neuropsychological, Morphological and Movement Sciences, University of Verona, Verona, Italy
- S.S.O. di Riabilitazione dell'Ospedale Policlinico
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sensory-motor Integration Training
Conventional neurorehabilitation
Arm Description
Outcomes
Primary Outcome Measures
Clinical assessment procedures: - Berg Balance Scale (BBS) - Activities-specific Balance Confidence Scale (ABC) Instrumental assessment procedures: - Stabilometric assessment
Secondary Outcome Measures
Clinical evaluation - Walking evaluation - Multiple Sclerosis Quality Of Life-54 (MSQOL-54) - Fatigue Severity Scale (FSS) - Postural Transfers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01040117
Brief Title
Sensori-motor Integration Training in Multiple Sclerosis
Official Title
Effects of Sensori-motor Integration Balance Training on Balance Disturbances in Patients With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita di Verona
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-remitting Multiple Sclerosis
Keywords
Equilibrium, Rehabilitation, Randomized Controlled Trial, Postural instability, Sensory-motor integration
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sensory-motor Integration Training
Arm Type
Experimental
Arm Title
Conventional neurorehabilitation
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Sensory-motor Integration Training
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional neurorehabilitation treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Fiaschi, Professor
Organizational Affiliation
Department of Neurological and Visual Sciences, University of Verona, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Section of Clinical Neurology, Department Neurological, Neuropsychological, Morphological and Movement Sciences, University of Verona, Verona, Italy
City
Verona
ZIP/Postal Code
37124
Country
Italy
Facility Name
S.S.O. di Riabilitazione dell'Ospedale Policlinico
City
Verona
ZIP/Postal Code
37126
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
18941933
Citation
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.
Results Reference
background
PubMed Identifier
18845654
Citation
Cattaneo 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.
Results Reference
background
PubMed Identifier
17875557
Citation
Cattaneo 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.
Results Reference
background
PubMed Identifier
25583852
Citation
Gandolfi 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.
Results Reference
derived
Links:
URL
http://www.aism.it/index.aspx?codpage=hp
Description
The website of the Italian Foundation of Multiple Sclerosis
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Sensori-motor Integration Training in Multiple Sclerosis
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