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Stabilometric Assessment of Balance Recovery in Persons With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT02131285
Recruitment Status : Completed
First Posted : May 6, 2014
Last Update Posted : May 6, 2014
Sponsor:
Information provided by (Responsible Party):
Fondazione Don Carlo Gnocchi Onlus

Study Description
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Brief Summary:

Background: Balance control relies on accurate perception of visual, somatosensory and vestibular cues. Sensory flow is impaired in Multiple Sclerosis (MS) and little is known about the ability of the sensory systems to adapt after neurological lesions reducing sensory impairment. The aims of the present study were to verify whether:

  1. Balance rehabilitation administered in a challenging sensory conditions would improve stability in upright posture
  2. the improvement in a treated sensory condition would transfer to a non treated sensory condition.

Methods: Fifty three persons with Multiple Sclerosis, median (min-max) Expanded Disability Status Scale score of 5 (2.5-6.5), participated in a Randomized Controlled Trial and were randomly assigned to two groups. The Experimental group received balance rehabilitation aimed at improving motor and sensory strategies. The Control group received rehabilitation treatment which did not include training of sensory strategies. Persons with Multiple Sclerosis were blindly assessed by means of a stabilometric platform with eyes open, eyes closed and dome, on both firm surface and foam. Anterior-posterior and medio-lateral sway, velocity of sway and the length of Center of Pressure (CoP) trajectory were calculated in the six sensory conditions.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Sensory training Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stabilometric Assessment of Context Dependent Balance Recovery in Persons With Multiple Sclerosis: a Randomized Controlled Study
Study Start Date : January 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sensory training
Experimental group received balance rehabilitation aimed at improving motor strategies and sensory strategies. Subjects in this group were treated to improve recovery of sensory impairment and were given exercises in the impaired sensory conditions, inhibiting the reliable sensory systems and forcing the Central Nervous System to use the impaired ones.
 Other: Sensory training
No Intervention: No sensory strategy
Control group received usual care rehabilitation which did not include training of sensory strategies.


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline at three weeks (end of treatment) for the following variables: Length [mm]; Velocity[mm/s]; Sway[mm] [ Time Frame: Baseline, 3 weeks (end of treatment) ]

    Multivariate assessment. Length [mm]: length of CoP trajectory computed as sum of CoP displacement on the platform surface for each frame; Velocity: velocity of oscillations along anterior-posterior (VelAP) and medio-lateral (VelML) axes. These are computed as the first time derivative of CoP AP and ML displacement.

    Sway: standard deviation of CoP time series along anterior-posterior (SwayAP) and medio-lateral (SwayML) axes;



Secondary Outcome Measures :
  1. Number of falls [ Time Frame: baseline, 3 weeks (end of treatment) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically or laboratory definite relapsing-remitting, primary or secondary progressive MS

Exclusion Criteria:

  • Inability to stand independently in upright position for 30 seconds
  • Inability to walk for 6 m even with an assistive device
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02131285


Locations
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Italy
Fondazione Don Gnocchi ONLUS
Milan, Italy, 20148
Sponsors and Collaborators
Fondazione Don Carlo Gnocchi Onlus
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier: NCT02131285    
Other Study ID Numbers: FDG_Falls_01
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014
Keywords provided by Fondazione Don Carlo Gnocchi Onlus:
Rehabilitation,
Balance,
Sensory strategies,
Multiple Sclerosis,
Postural control
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases