Sensori-motor Integration Training in Multiple Sclerosis
Condition: Relapsing-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Early Phase 1

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.
    

Intervention name(s): Sensory-motor Integration Training; Conventional neurorehabilitation treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Equilibrium; Rehabilitation; Randomized Controlled Trial; Postural instability; Sensory-motor integration