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Stabilometric Assessment of Balance Recovery in Persons With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Sensory training
Sponsored by
Fondazione Don Carlo Gnocchi Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Rehabilitation,, Balance,, Sensory strategies,, Multiple Sclerosis,, Postural control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondazione Don Gnocchi ONLUS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sensory training

No sensory strategy

Arm Description

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.

Control group received usual care rehabilitation which did not include training of sensory strategies.

Outcomes

Primary Outcome Measures

Change from baseline at three weeks (end of treatment) for the following variables: Length [mm]; Velocity[mm/s]; Sway[mm]
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

Number of falls

Full Information

First Posted
April 24, 2014
Last Updated
May 5, 2014
Sponsor
Fondazione Don Carlo Gnocchi Onlus
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1. Study Identification

Unique Protocol Identification Number
NCT02131285
Brief Title
Stabilometric Assessment of Balance Recovery in Persons With Multiple Sclerosis
Official Title
Stabilometric Assessment of Context Dependent Balance Recovery in Persons With Multiple Sclerosis: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus

4. Oversight

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Rehabilitation,, Balance,, Sensory strategies,, Multiple Sclerosis,, Postural control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sensory training
Arm Type
Experimental
Arm Description
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.
Arm Title
No sensory strategy
Arm Type
No Intervention
Arm Description
Control group received usual care rehabilitation which did not include training of sensory strategies.
Intervention Type
Other
Intervention Name(s)
Sensory training
Primary Outcome Measure Information:
Title
Change from baseline at three weeks (end of treatment) for the following variables: Length [mm]; Velocity[mm/s]; Sway[mm]
Description
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;
Time Frame
Baseline, 3 weeks (end of treatment)
Secondary Outcome Measure Information:
Title
Number of falls
Time Frame
baseline, 3 weeks (end of treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Fondazione Don Gnocchi ONLUS
City
Milan
ZIP/Postal Code
20148
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
17875557
Citation
Cattaneo D, Jonsdottir J, Zocchi M, Regola A. Effects of balance exercises on people with multiple sclerosis: a pilot study. Clin Rehabil. 2007 Sep;21(9):771-81. doi: 10.1177/0269215507077602.
Results Reference
background
PubMed Identifier
24912561
Citation
Cattaneo D, Jonsdottir J, Regola A, Carabalona R. Stabilometric assessment of context dependent balance recovery in persons with multiple sclerosis: a randomized controlled study. J Neuroeng Rehabil. 2014 Jun 10;11:100. doi: 10.1186/1743-0003-11-100.
Results Reference
derived

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Stabilometric Assessment of Balance Recovery in Persons With Multiple Sclerosis

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