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Falls Prevention and Balance Rehabilitation in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Falls Prevention
Reduction of limitations at body function and activity levels
Sponsored by
Fondazione Don Carlo Gnocchi Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention

    Control

    Arm Description

    Participants in the intervention group received at least 25-45' of balance treatment. The balance treatments were aimed at improving participants' control of the position and movement of the center of mass and body segments during static, dynamic and transitional tasks.

    Participants in the control group were treated to reduce limitations at body function and activity levels, while treatment for balance disorders was restricted to a maximum of 10' per session. Treatment mainly focused on increasing range of joints motion, reducing of muscle contractures and strength training.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    March 6, 2015
    Last Updated
    March 11, 2015
    Sponsor
    Fondazione Don Carlo Gnocchi Onlus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02390830
    Brief Title
    Falls Prevention and Balance Rehabilitation in Multiple Sclerosis
    Official Title
    Falls Prevention and Balance Rehabilitation in Multiple Sclerosis: a Bi-centre Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2011 (undefined)
    Primary Completion Date
    October 2013 (Actual)
    Study Completion Date
    October 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fondazione Don Carlo Gnocchi Onlus

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    119 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Participants in the intervention group received at least 25-45' of balance treatment. The balance treatments were aimed at improving participants' control of the position and movement of the center of mass and body segments during static, dynamic and transitional tasks.
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Participants in the control group were treated to reduce limitations at body function and activity levels, while treatment for balance disorders was restricted to a maximum of 10' per session. Treatment mainly focused on increasing range of joints motion, reducing of muscle contractures and strength training.
    Intervention Type
    Other
    Intervention Name(s)
    Falls Prevention
    Intervention Type
    Other
    Intervention Name(s)
    Reduction of limitations at body function and activity levels
    Primary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Learn more about this trial

    Falls Prevention and Balance Rehabilitation in Multiple Sclerosis

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