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

CompletedNot a drug-phase studyMS (type not specified)NCT02390830

What it found

No results found

We found no results in the registry or in papers.

This trial finished 13 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Falls Prevention

Compared with

  • Reduction of limitations at body function and activity levels

What it measured

Main measures

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

    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

Who could take part

MS (type not specified)

Show the full criteria

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Mar 2011

      2. Main results due

        Oct 2013

      3. Finished

        Oct 2013

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