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Falls Prevention and Balance Rehabilitation in Multiple Sclerosis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02390830
Enrollment
119
Registered
2015-03-18
Start date
2011-03-31
Completion date
2013-10-31
Last updated
2015-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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.

Interventions

OTHERFalls Prevention
OTHERReduction of limitations at body function and activity levels

Sponsors

Fondazione Don Carlo Gnocchi Onlus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026