Comparison of Lokomat and Aquatic Exercise for Individuals With Chronic Incomplete Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      Many people with spinal cord injury (SCI) hold some ability to move their leg muscles, and
      are therefore considered to demonstrate a motor incomplete injury. After such a spinal cord
      injury, individuals are able to walk less both in their home and in their community.
      De-conditioning, or a lack of endurance and fitness also occurs. Several methods are
      available to try to improve walking ability and the fitness of persons with motor incomplete
      spinal cord injury. This study examines two of these methods. The first is the use of
      robotically assisted body-weight supported walking using a device called the Lokomat. The
      second is aquatic or pool-based exercise. The investigators are researching the impact of
      these two techniques on walking ability and fitness in people who experienced motor
      incomplete spinal cord injury for at least 12 months.
    

Detailed description: 
      This research will occur in two centers Kernan Orthopedics and Rehabilitation Hospital in
      Baltimore, Maryland and Shepherd Center in Atlanta, Georgia. A total of 36 volunteers over a
      three year period are needed. In order to qualify for this study, individuals must be 18 to
      65 years old with a motor incomplete SCI. The level of injury can range from the fourth
      cervical level in the neck to the twelfth thoracic level in the back. Potential volunteers
      must be able to tolerate standing in a standing frame for at least 30 minutes. Individuals
      will be assessed by a physician to determine their eligibility for the study and if
      participating in this type of exercise would be safe. Participants must be able to understand
      the study requirements and sign an informed consent document.

      Participants will need to commit to a total of seven months. Included in this time is:
      testing, then the 3 months of exercise, testing, 2 week break, then the second 3 months of
      exercise, and a final testing. Half of the group will start with the Lokomat training and
      half will start wtih aquatic exercise. Each group will then switch to the other exercise
      condition. Exercise sessions will occur three times per week and last approximately 45-55
      minutes. A physical therapist will provide personal direction for each of the exercise
      groups. Walking ability and cardiovascular fitness, as well as muscle strength will be
      assessed before starting exercise, at the three-month point and then at the six month point.

      It is hoped that that this type of exercise therapy will help individuals with motor
      incomplete spinal injury both walk better and experience better heart-lung fitness and
      endurance. The risks associated with this type of study are similar to any type of
      cardiovascular exercise. In addition, individuals with spinal cord injury may present with
      some medical conditions, there may be other risks of the study. The physicians and therapists
      involved in the research will discuss these risks in detail with the individuals who enroll.

      This type of research is important to better understand how best to prescribe exercise
      treatments to people with spinal injury. This is especially true with regards to aquatic
      therapy, since there is very little scientific data on its effect in this group of
      individuals. The rigorous assessment of aquatic exercise, which is already available in many
      communities, may expand the fitness opportunities for individuals with incomplete spinal cord
      injury.
    

Intervention name(s): Lokomat treadmill training; Aquatic exercise therapy
Intervention type(s): Device; Other
Intervention description(s): Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session; Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session
Other intervention name(s): Robotic Body Weight Supported Locomotor Training; Aquatic Therapy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: robotic weight support; aquatic exercise; incomplete motor spinal cord injury; ASIA C and D