Stabilometric Assessment of Balance Recovery in Persons With Multiple Sclerosis

NCT ID: NCT02131285

Last Updated: 2014-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2007-09-30

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sensory training

Intervention Type: OTHER

No sensory strategy

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sensory training

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione Don Gnocchi ONLUS

Milan, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 17875557 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24912561 (View on PubMed)

Other Identifiers

FDG_Falls_01

Identifier Type: -

Identifier Source: org_study_id