Robotically Assisted Treadmill Training in Spinal Cord Injury (SCI)

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Brief Title

Robotically Assisted Treadmill Training in Spinal Cord Injury (SCI)

Official Title

Cardiovascular Parameters for Lokomat Training in Chronic Incomplete SCI

Brief Summary

      This proposal investigates the hypothesis that progressive aerobic exercise with Lokomat is
      feasible in people with motor incomplete spinal cord injury, and three months of training
      will improve cardiovascular fitness and gait functionality when compared to physical therapy

Detailed Description

      Little information is available about the cardiovascular effects of robotically assisted
      partial weight support treadmill training devices such as Lokomat in chronic incomplete
      spinal cord injured subjects. Task-oriented aerobic exercise has the potential to improve
      both neuromuscular function and cardiovascular metabolic fitness in neurological populations.
      Since spinal cord injured individuals are at an increased risk of developing premature
      cardiovascular disease, the investigation of robotic-assisted interventions in spinal cord
      injury (SCI) such as the Lokomat may have important health benefits in both cardiovascular
      fitness as well as functional mobility.

      This proposal investigates the hypothesis that progressive aerobic exercise with Lokomat is
      feasible in motor incomplete SCI, and three months of training will improve cardiovascular
      fitness and gait functionality when compared to physical therapy controls. We propose a
      two-phase study to examine the feasibility, reliability and utility of aerobic exercise
      metabolic testing and training during robotically assisted partial weight support treadmill
      walking in individuals with chronic motor incomplete spinal cord injury (CMISCI). During the
      first phase of the study we will manipulate Lokomat training parameters of treadmill speed
      and percent of partial weight support to assess the effect of these changes on heart rate,
      perceived exertion, and oxygen consumption in untrained chronic motor incomplete spinal cord
      injured subjects. Subjects will be asked to maintain cardiovascular or muscular effort during
      testing and will be monitored in this regard by the force biofeedback system built into the
      Lokomat. After determining threshold levels for initial cardiovascular response, submaximal
      and then peak exercise testing will be attempted. These studies will be repeated on a
      separate day to determine the reliability of the testing results. Thirty-six subjects with
      varying levels of injury between C4 and L2 and ASIA (American Spinal Injury) Impairment
      Scales of C and D will be recruited. We anticipate that subjects with greater ASIA motor
      scores will require either a faster initial treadmill speed or less partial weight support to
      produce an initial cardiovascular response. It is also anticipated that peak exercise testing
      using open circuit spirometry with subjects on the Lokomat will be a feasible, reliable and
      valid measurement. This phase of the study will be aimed at establishing guidelines for
      determining initial training parameters for use in an aerobic exercise protocol using the

      The second phase of this pilot study will be a controlled trial of three-month progressive
      aerobic Lokomat exercise in chronic incomplete spinal cord injured subjects. The aim of this
      trial will be to determine whether progressive Lokomat training will improve cardiovascular
      fitness and ambulatory function when compared to matched impairment severity CMISCI subjects
      receiving the same duration of usual physical therapy care. Thirty-six subjects will be
      recruited into this phase of the study. Open spirometric evaluation of cardiovascular
      parameters as outlined in phase one of the proposal will be measured at baseline, 1 months,
      and 3 months. Initial, six-week and post-study ambulatory function evaluations including the
      WISCI (Walking Index for Spinal Cord Injury), a timed 10 meter walk, a measured walk over 6
      minutes, and a gait analysis will also be determined. It is hypothesized that aerobic Lokomat
      exercise will improve cardiovascular fitness as determined by an increase in VO2 (oxygen
      consumption) peak and improve function as determined by timed walks and gait parameters in
      these subjects. The results of this pilot and development study will provide the necessary
      information to design larger randomized clinical trials.

Study Type


Primary Outcome

Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments

Secondary Outcome

 Body Mass




Lokomat Training

Study Arms / Comparison Groups

 Lokomat training
Description:  Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

October 2006

Completion Date

June 2011

Primary Completion Date

June 2011

Eligibility Criteria

        Inclusion Criteria:

          -  Acute onset Spinal Cord Injury or Disease at least 12 months prior to enrollment

          -  Age 18 to 80

          -  Level of injury from C4 to L2

          -  ASIA impairment scale either C or D

          -  Able to tolerate standing frame for at least 30 minutes

        Exclusion Criteria:

          -  History of unstable angina, recent MI (myocardial infarction), CHF (congestive heart
             failure) or clinically significant valvular dysfunction

          -  History of recent hospitalization (<3 months) for a major medical problem




18 Years - 80 Years

Accepts Healthy Volunteers



Peter Gorman, MD MS, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor

US Department of Veterans Affairs


 University of Maryland, College Park

Study Sponsor

Peter Gorman, MD MS, Principal Investigator, VA Maryland Health Care System, Baltimore

Verification Date

April 2014