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
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:
- Balance rehabilitation administered in a challenging sensory conditions would improve stability in upright posture
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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;
- Number of falls [ Time Frame: baseline, 3 weeks (end of treatment) ]
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
|Fondazione Don Gnocchi ONLUS|
|Milan, Italy, 20148|