Effects of GE-O System on Gait Impairments in Multiple Sclerosis Subjects

Summary

Multiple sclerosis (MS) is the most common non-traumatic cause of neurologic disability in young adults,affecting mobility and ambulation in the majority of patients. At least 50% of individuals with MS will require an assistive device to ambulate within ten years of diagnosis. Impaired mobility is one of the top three factors associated with inability to continue working. In addition,impaired mobility and the inability to walk functionally translate into significant costs for personal assistance, medical complications, and lost wages because of unemployment. Clearly,maximizing the ability to ambulate, as well as perform safe and effective transfers,is a fundamental goal in the management of individuals with MS. None of the currently available MS disease-modifying medications have been shown to stop or reverse gait disability. Repetitive locomotor training is an innovative approach in gait disturbances in patients with MS. Only scant data on this issue is available and all the studies have been performed by means of treadmill training or robot assisted gait training (RAGT) approaches. The recent introduction of a robotic device to gait rehabilitation showed a significant improvement in gait ability in patients with neurological disease due to the possibility of being trained under a graduated body weight support condition and being being guided to reproduce a physiologic gait pattern.

In 2010 a novel device called GE-O System was developed. It enables patients to repetitively practice walking on the floor and also climb up and down stairs. To date, the effectiveness of this novel device has not yet been evaluated in patients with MS. The aims of the study are as follows: to evaluate the effectiveness of a specific gait training program consisting of the GE-O System in patients with MS in improving balance and walking ability,reducing fatigue,the frequency of falls,the fear of falling and disability in activities of daily living and finally,improving quality of life.

Conditions

• Multiple Sclerosis

Interventions

OTHER

GE-O SYSTEM

The first group will be subjected to RAGT for 9 weeks (2 sessions/ week) with a total of 18 sessions by mean of GE-O System (9). During each session, the patients will practice 15 to 20 min of simulated floor walking followed by 5 to 10 min of repetitive simulated stair climbing up and down. Breaks will be optional, but uninterrupted training intervals of at least 5 min for simulated floor walking and 3 min of simulated stair climbing will be required. When the patient reaches the maximum amount of time, speed of gait will then be progressively increased. Each session will last up to 50 minutes, the first 30 minutes will be dedicated to gait training and the last 20 minutes to stretch the lower limb's muscles.

OTHER

Conventional training

The conventional walking group will be subjected to a conventional gait training for 9 weeks (2 sessions/week) with a total of 18 sessions. Each session will last altogether 50 minutes, the first 30 minutes will be dedicated to gait and stair climbing up and down training while the last 20 minutes to stretch the lower limb's muscles.

Sponsors & Collaborators

• Universita di Verona

  lead OTHER

Principal Investigators

• Nicola Smania, MD · Neuromotor and Cognitive Rehabilitation Center Department of Neurological and Movement Sciences University of Verona, Verona, Italy P.zza L.A. Scuro, 10 37134 Verona, Italia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2016-09-30

Completion

2016-12-31

Countries

• Italy

Study Locations