Stabilometric Assessment of Balance Recovery in Persons With Multiple Sclerosis

NCT02131285 | Completed

• 1 other identifier: FDG_Falls_01
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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. 1.Balance rehabilitation administered in a challenging sensory conditions would improve stability in upright posture
2. 2.the improvement in a treated sensory condition would transfer to a non treated sensory condition.

Conditions

Multiple Sclerosis

Keywords

Rehabilitation,; Balance,; Sensory strategies,; Multiple Sclerosis,; Postural control

Outcome Measures

Primary Outcomes (1)

• 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;

  Baseline, 3 weeks (end of treatment)

Secondary Outcomes (1)

• Number of falls

  baseline, 3 weeks (end of treatment)

Study Arms (2)

Sensory training

EXPERIMENTAL

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 sensory strategy

NO INTERVENTION

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

Interventions

Sensory training OTHER

Sensory training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically or laboratory definite relapsing-remitting, primary or secondary progressive MS

You may not qualify if:

• Inability to stand independently in upright position for 30 seconds
• Inability to walk for 6 m even with an assistive device

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Fondazione Don Gnocchi ONLUS

Milan, 20148, Italy

Location

Related Publications (2)

• 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.

  PMID: 17875557 BACKGROUND

• 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.

  PMID: 24912561 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: May 6, 2014
• Study Start: January 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

IT (1)