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Robot-assisted Gait Training in Multiple Sclerosis Subjects

This study has been completed.
Sponsor:
Collaborator:
Azienda Ospedaliero, Universitaria Pisana
Information provided by (Responsible Party):
Sofia Straudi, MD, University Hospital of Ferrara
ClinicalTrials.gov Identifier:
NCT01435694
First received: September 14, 2011
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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 Intervention
Multiple Sclerosis
Behavioral: Lokomat (Hocoma, Switzerland)
Behavioral: Conventional Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University Hospital of Ferrara:

Primary Outcome Measures:
  • motor unit firing rate characteristics [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    It will be performed through the analysis of superficial EMG signals during isometric knee extension.


Secondary Outcome Measures:
  • walking endurance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    six minute walking test

  • mobility [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Timed Up and Go Test

  • balance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Berg Balance Test

  • gait speed [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    10 meter test

  • Fatigue [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Fatigue Severy Scale

  • quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    SF-36

  • depression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    patient health questionnaire (PHQ-9)


Enrollment: 60
Study Start Date: April 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435694

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

No publications provided

Responsible Party: Sofia Straudi, MD, MD, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT01435694     History of Changes
Other Study ID Numbers: FISM_grant_2010
Study First Received: September 14, 2011
Last Updated: January 15, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by University Hospital of Ferrara:
multiple sclerosis
gait rehabilitation

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

ClinicalTrials.gov processed this record on November 25, 2014