Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01407354 |
| Other study ID # |
HP-00047439 |
| Secondary ID |
SC090147 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2011 |
| Est. completion date |
July 2014 |
Study information
| Verified date |
May 2021 |
| Source |
University of Maryland, Baltimore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
