Robotically Assisted Treadmill Training in Spinal Cord Injury (SCI)
Condition: Paraplegia; Quadriplegia; Spinal Cord Injury; Tetraplegia
MeSH terms: Spinal Cord Injuries; Paraplegia; Quadriplegia
Study type: Interventional

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
      controls
    

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
      Lokomat.

      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.
    

Intervention name(s): Lokomat Training; Home stretching then Lokomat training
Intervention type(s): Device; Other
Intervention description(s): The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.; Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm. After 3 months the patients will be crossed over to Lokomat training for an additional 3 months. This training will be the same as given to the individuals originally randomized to the Lokomat treatment intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiovascular Fitness; Exercise; Gait; Spinal Cord Injury; Treadmill Training