Falls Prevention and Balance Rehabilitation in Multiple Sclerosis

Sponsor

Fondazione Don Carlo Gnocchi Onlus (Other)

Overall Status

Completed

CT.gov ID

NCT02390830

Collaborator

(none)

119

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Other: Falls Prevention Other: Reduction of limitations at body function and activity levels	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

119 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention 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.	Other: Falls Prevention
Active Comparator: Control 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.	Other: Reduction of limitations at body function and activity levels

Arm

Intervention/Treatment

Experimental: Intervention

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.

Other: Falls Prevention

Active Comparator: Control

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.

Other: Reduction of limitations at body function and activity levels

Outcome Measures

Primary Outcome 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Fondazione Don Carlo Gnocchi Onlus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondazione Don Carlo Gnocchi Onlus

ClinicalTrials.gov Identifier:

NCT02390830

Other Study ID Numbers:

RCT_SM_Falls

First Posted:

Mar 18, 2015

Last Update Posted:

Mar 18, 2015

Last Verified:

Mar 1, 2015

Additional relevant MeSH terms:

Multiple Sclerosis

Sclerosis

Study Results

No Results Posted as of Mar 18, 2015