Sensori-motor Integration Training in Multiple Sclerosis

Relapsing-remitting Multiple Sclerosis Clinical Trial

Official title:

Effects of Sensori-motor Integration Balance Training on Balance Disturbances in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01040117
• Other study ID #: FISM-2009
• Secondary ID: 2009/R/27
• Status: Completed
• Phase: Phase 0
• First received: December 28, 2009
• Last updated: March 14, 2012
• Start date: December 2009
• Est. completion date: January 2012

Study information

• Verified date: March 2012
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-remitting Multiple Sclerosis
• Sclerosis

Intervention

Procedure:
• Sensory-motor Integration Training
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 treatment
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.

Locations

Country	Name	City	State
Italy	S.S.O. di Riabilitazione dell'Ospedale Policlinico	Verona
Italy	Section of Clinical Neurology, Department Neurological, Neuropsychological, Morphological and Movement Sciences, University of Verona, Verona, Italy	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical assessment procedures: - Berg Balance Scale (BBS) - Activities-specific Balance Confidence Scale (ABC) Instrumental assessment procedures: - Stabilometric assessment		At recruitment, after treatment (5 weeks) and in the follow-up (1 month)	Yes
Secondary	Clinical evaluation - Walking evaluation - Multiple Sclerosis Quality Of Life-54 (MSQOL-54) - Fatigue Severity Scale (FSS) - Postural Transfers		At recruitment, after treatment (5 weeks) and in the follow-up (1 month)	Yes

External Links

•   The website of the Italian Foundation of Multiple Sclerosis
•   The website of the Verona Provincial Foundation of Multiple Sclerosis