Status:
COMPLETED
Comparison of Lokomat and Aquatic Exercise for Individuals With Chronic Incomplete Spinal Cord Injury
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Shepherd Center, Atlanta GA
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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, individua...
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...
Eligibility Criteria
Inclusion
- Age 18-65 years
- Level of injury between C4 and T12 based on ASIA classification
- Chronic (greater than 12 months) spinal injury
- Completion of all conventional inpatient rehabilitation therapy
- Motor incomplete spinal cord injury (AIS C or D)
- Competency to provide informed consent
- Ability to tolerate a standing frame for at least 30 minutes
Exclusion
- Currently performing aquatic therapy or Lokomat training as part of clinical care
- Complete or concurrent lower motor neuron injury as defined by the absence of reflexes bilaterally at the knees and the ankles
- Uncontrolled seizures
- Skin opening greater than 2 cm in diameter
- Alcohol consumption \> 3 oz liquor, or 3 x 4oz of wine, or 36 oz of beer per day
- Cardiac history of (a) unstable angina, (b) recent (\< 3 months) myocardial infarction, (c) congestive heart failure (NYHA category II), or (d) hemodynamically significant valvular dysfunction
- Medical history of (a) recent hospitalization for severe disease or surgery, (b)undiagnosed diabetics (fasting glucose \> 120) or poorly controlled diabetics (those not on a stable regimen for \>6 months) unable to be controlled with medical treatment, (c) significant orthopedic or chronic pain conditions limiting exercise, (d) active neoplastic disease, (e) pulmonary or renal disease, and (f) presence of any serious medical condition with a prognosis for death or dependency in the next 2 months
- History of long bone fracture in the legs
- Frequent bouts of autonomic dysreflexia (as determined by the principal investigator)
- Any other medical co-morbidities that based on the judgment of the local principal investigator would preclude safe participation in the study
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01407354
Start Date
April 1 2011
End Date
July 1 2014
Last Update
May 26 2021
Active Locations (2)
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1
Shepherd Center, Virginia C. Crawford Research Institute
Atlanta, Georgia, United States, 30309-1465
2
University of Maryland Rehabilitation & Orthopaedic Institute (formerly known as Kernan Hospital)
Baltimore, Maryland, United States, 21207