Robot-assisted Gait Training in Multiple Sclerosis Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01435694
Recruitment Status : Completed
First Posted : September 19, 2011
Last Update Posted : January 16, 2014
Azienda Ospedaliero, Universitaria Pisana
Information provided by (Responsible Party):
Sofia Straudi, MD, University Hospital of Ferrara

Brief Summary:

Aims of the study:

This is a randomized-controlled trial to test the effects of robot-assisted gait training on locomotor function and motor unit firing rate in multiple sclerosis subjects with severe gait impairments. The control group will be treat with conventional physical therapy.

Subjects and methods:

60 multiple sclerosis patients will be recruited in two outpatient rehabilitation clinics.

Informed consent will be obtained. Participants will be randomized to Robot-assisted gait training (experimental group) or conventional therapy (control group) through a randomization stratification approach, according to a block randomization of 4.

The experimental group will receive 12 robot-assisted gait training sessions over 6 weeks (2 sessions/week). The control group will receive 12 conventional therapy sessions over 6 weeks (2 sessions/week), that will focus on gait training.

Primary outcome measures will be both neurophysiological measures (motor unit firing rate characteristics) and clinical test for gait speed (10m walking test). Secondary outcome measures will include: clinical tests of walking endurance (six minute walking test), balance (Berg Balance Test) and mobility (Up and Go Test).

Clinical assessment of lower-extremities spasticity (Modified Ashworth Scale), motor fatigue (Fatigue Severity Scale), depression (PHQ-9) and quality of life (SF-36) will be monitored. Subject acceptance and confidence in the treatments will be track with a Visual Analog Scale. Outcome measures will be assessed the week prior to treatment initiation (T0), after 6 sessions (T1), the week after the end of treatment (T2) and at 3 months follow-up (T3) to evaluate treatments retention, by a clinician blinded to the treatment.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Lokomat (Hocoma, Switzerland) Behavioral: Conventional Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Robot-assisted Gait Training on Locomotor Function and Motor Unit Firing in Multiple Sclerosis Subjects With Severe Gait Impairments. A Randomized Control Trial
Study Start Date : April 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Robot-assisted gait training
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%. Training sessions will last for an hour with 30 minutes of real walking time, because subject set-up in the device take approximately 30 minutes.
Behavioral: Lokomat (Hocoma, Switzerland)
Other Name: robotic-driven gait orthosis
Active Comparator: Conventional Therapy
Training sessions will focus on locomotor function improvements. Subjects will receive 45 minutes 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 they will be trained on walking abilities (like walking at different speeds, rapid changes directions) for 30 minutes with or without assistive aids.
Behavioral: Conventional Therapy

Primary Outcome Measures :
  1. motor unit firing rate characteristics [ Time Frame: 12 months ]
    It will be performed through the analysis of superficial EMG signals during isometric knee extension.

Secondary Outcome Measures :
  1. walking endurance [ Time Frame: 12 months ]
    six minute walking test

  2. mobility [ Time Frame: 12 months ]
    Timed Up and Go Test

  3. balance [ Time Frame: 12 months ]
    Berg Balance Test

  4. gait speed [ Time Frame: 12 months ]
    10 meter test

  5. Fatigue [ Time Frame: 12 months ]
    Fatigue Severy Scale

  6. quality of life [ Time Frame: 12 months ]

  7. depression [ Time Frame: 12 months ]
    patient health questionnaire (PHQ-9)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • males and females, community dwelling, age 18 or older
  • diagnosis of multiple sclerosis in a stable phase, with relapses > 6 months prior to study enrollment
  • moderate to severe gait impairments referred to Expanded Disability Status Scale (EDSS) between 6 and 7

Exclusion Criteria:

  • neurologic conditions in addition to multiple sclerosis that may affect motor function
  • medical conditions likely to interfere with the ability to safely complete the study
  • impaired cognitive functioning: Mini Mental Status Examination < 24
  • severe lower-extremities spasticity or contractures that may limit range of motion(Ashworth score >4 for hip, knee or ankle flexors/extensors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01435694

Physical Medicine and Rehabilitation Department
Ferrara, Italy, 44100
Sponsors and Collaborators
University Hospital of Ferrara
Azienda Ospedaliero, Universitaria Pisana
Study Chair: Sofia Straudi, MD Ferrara University Hospital
Study Chair: Carmelo Chisari, MD Pisana University Hospital
Principal Investigator: Nino Basaglia, MD Ferrara University Hospital

Responsible Party: Sofia Straudi, MD, MD, University Hospital of Ferrara Identifier: NCT01435694     History of Changes
Other Study ID Numbers: FISM_grant_2010
First Posted: September 19, 2011    Key Record Dates
Last Update Posted: January 16, 2014
Last Verified: January 2014

Keywords provided by Sofia Straudi, MD, University Hospital of Ferrara:
multiple sclerosis
gait rehabilitation

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases