Robot-assisted Gait Training on Mobility in Severely Disabled Multiple Sclerosis Patients

Summary

Gait disabilities affect personal activities and quality of life of progressive multiple sclerosis (MS) patients. A robot-driven gait orthosis allowing a more effective support of walking movements and imitation of a nearly normal gait pattern during treadmill training at a higher speed has been developed and recently introduced in clinical settings. However, until now few studies evaluated the effects of Robot-Assisted Gait Training (RAGT) in a group of stroke, spinal cord injury and MS subjects.

In addition, the training-induced neural and biological changes potentially related to the mechanisms of recovery remain undefined.

The primary aims of this study are:

to test the feasibility of RAGT in a group of progressive severely disabled MS patients and to test the hypothesis that this intensive intervention could have higher benefit, compared with conventional therapy alone, in mobility improvement as assessed by the Timed 25 Foot Walk (T25FW)

The secondary aims of this study are:

to determine whether fatigue, Quality of life, balance and locomotor function are improved by RAGT; to determine whether gait training influences markers of plasticity including clinical and circulating biomarkers to search for a possible correlation between clinical outcomes and clinical and circulating biomarkers

Conditions

• Multiple Sclerosis

Interventions

DEVICE

Robot-assisted gait training

Patients will receive 12 training sessions, lasting for an hour with 30 minutes of real walking time, over 4 weeks (3 sessions/week) of RAGT. Subjects will wear a harness attached to a system to provide body weight support and they will walk on a treadmill with the help of a robotic-driven gait orthosis. The legs are guided according to a physiological gait pattern. The torque of the knee and hip drives can be adjusted from 100% to 0% for one or both legs. The speed of the treadmill can be adjusted from 0 km/h to approximately 3 km/h and body weight support from 0% to 100%. During the first session we will set these parameters according to subject characteristics and demand level. As training will progress, adjustments in the three parameters previously described will be performed.

OTHER

Conventional therapy

The control group will receive 12 conventional therapy sessions over 4 weeks (3 sessions/week), that will focus on gait training. Subjects will receive 1 hour of individual conventional physiotherapy for session. During the first 5-10 minutes the subjects will perform lower-limb and core stretching exercises to increase muscles flexibility; then they'll deal with lower-limb muscles strengthening exercises tailored on their baseline characteristics (10 minutes). After that, assisted over-ground walking training will be performed.

Sponsors & Collaborators

• Regione Emilia-Romagna

  collaborator OTHER

• Università degli Studi di Ferrara

  collaborator OTHER

• University Hospital of Ferrara

  lead OTHER

Principal Investigators

• Sofia Straudi, MD · Ferrara Rehabilitation Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-28

Primary Completion

2018-02-28

Completion

2018-02-28

Countries

• Italy

Study Locations