Falls Prevention and Balance Rehabilitation in Multiple Sclerosis

Don Carlo Gnocchi Onlus Foundation

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: Reduction of limitations at body function and activity levels; Other: Falls Prevention

Study type: Interventional

Funder types: Other

Identifiers

NCT02390830

RCT_SM_Falls

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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119 participants in 2 patient groups

Intervention

Experimental group

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.

Treatment:

Other: Falls Prevention

Control

Active Comparator group

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.

Treatment:

Other: Reduction of limitations at body function and activity levels