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Clinical Trials/NCT02131285
NCT02131285
Completed
N/A

Stabilometric Assessment of Context Dependent Balance Recovery in Persons With Multiple Sclerosis: a Randomized Controlled Study

Fondazione Don Carlo Gnocchi Onlus1 site in 1 country53 target enrollmentJanuary 2005

Overview

Phase
N/A
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Fondazione Don Carlo Gnocchi Onlus
Enrollment
53
Locations
1
Primary Endpoint
Change from baseline at three weeks (end of treatment) for the following variables: Length [mm]; Velocity[mm/s]; Sway[mm]
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2005
End Date
September 2007
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Number of falls(baseline, 3 weeks (end of treatment))

Study Sites (1)

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