Falls Prevention and Balance Rehabilitation in Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Falls Prevention

Other

Reduction of limitations at body function and activity levels

Other

Primary outcomes

Change from Baseline in Frequency of fallers at 2 and 4 months

Time frame: baseline, 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

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

Falls Prevention and Balance Rehabilitation in Multiple Sclerosis: a Bi-centre Randomized Control Trial

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Mar 18, 2015
Registry last updated: Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed