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OpenTrials
Completed

NCT Number: NCT02131285

Stabilometric Assessment of Balance Recovery in Persons With Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Don Gnocchi ONLUS

Milan, 20148, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sensory Training

Other

Primary outcomes

  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 outcomes

  1. Number of falls

    Time frame: baseline, 3 weeks (end of treatment)

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
May 6, 2014
Registry last updated
May 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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