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Falls Prevention and Balance Rehabilitation in Multiple Sclerosis

Not Applicable
Completed
Conditions
Multiple Sclerosis
Registration Number
NCT02390830
Lead Sponsor
Fondazione Don Carlo Gnocchi Onlus
Brief Summary

Background. Balance disorders and falls are common in People with Multiple Sclerosis (PwMS) Objective: Our hypothesis was that PwMS treated for balance disorders would reduce balance disorders and frequency of falls.

Methods: A bi-centre randomised Rater-blinded controlled trial. Participants in both groups received 20 treatment sessions. Participants in the intervention group received treatment aimed at improving control of the position and movement of the centre of mass and body segments. Participants in the control group received treatments to reduce limitations at activity and body function level.

Group allocation was done by an independent clinician by a randomization list made before the beginning of the study. Group allocation was kept concealed throughout the study and participants were not aware of group assignment.

Data was analyzed according to a preplanned protocol by using an intention to treat approach.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Not specified
Target Recruitment
119
Inclusion Criteria

Clinical diagnosis of Multiple Sclerosis Must be able to walk (also with aid) for 6m Must be able to maintain standing position with open eyes for at least 30".

Exclusion Criteria

Must not be able to maintain monopodalic-standing position for 10", Must not be able to to maintain tandem position for 30", cognitive disorders hampering the execution of the exercises/assessment.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change from Baseline in Frequency of fallers at 2 and 4 monthsbaseline, then participants were followed for the duration the outpatient treatment protocol, an average of 8 weeks, and at follow up 2 months after the end of the treatment protocol
Secondary Outcome Measures
NameTimeMethod

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