Falls Prevention and Balance Rehabilitation in Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Reduction of limitations at body function and activity levels; Other: Falls Prevention

• Registration Number: NCT02390830
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2015-03
• Study First Submitted: 2015-03-06
• Study First Submitted QC: 2015-03-11
• Last Update Submitted: 2015-03-11
• Study First Posted: 2015-03-18
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 119

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Reduction of limitations at body function and activity levels	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	Falls Prevention	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.

Primary Outcome Measures

Name	Time	Method
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