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Comparison of Lokomat and Aquatic Exercise for Individuals With Chronic Incomplete Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01407354
Recruitment Status : Completed
First Posted : August 2, 2011
Results First Posted : April 8, 2016
Last Update Posted : April 8, 2016
Shepherd Center, Atlanta GA
Information provided by (Responsible Party):
Paula Geigle, University of Maryland, College Park

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, 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: Lokomat treadmill training Other: Aquatic exercise therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lokomat and Aquatic Therapy in Chronic Motor Incomplete Spinal Cord Injury
Study Start Date : April 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lokomat Training
Lokomat robotic assisted treadmill training Lokomat Treadmill Training
Device: Lokomat treadmill training
Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session
Other Name: Robotic Body Weight Supported Locomotor Training

Active Comparator: Aquatic Therapy
Aquatic exercise therapy
Other: Aquatic exercise therapy
Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session
Other Name: Aquatic Therapy

Primary Outcome Measures :
  1. Number of Participants Demonstrating 10% Change: Arm Ergometer and Lokomat Metabolic Cart VO2 Peak [ Time Frame: 7 months ]
    Peak VO2 via Arm Ergometer and Lokomat with metabolic cart

Secondary Outcome Measures :
  1. Number of Movement Recorded by Activity Monitor (SAM) [ Time Frame: 7 months ]
    SAM movements not just steps were gathered one time pre, crossover and post and worn on ankle for 5 days; percent change for each intervention

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01407354

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United States, Georgia
Shepherd Center, Virginia C. Crawford Research Institute
Atlanta, Georgia, United States, 30309-1465
United States, Maryland
University of Maryland Rehabilitation & Orthopaedic Institute (formerly known as Kernan Hospital)
Baltimore, Maryland, United States, 21207
Sponsors and Collaborators
University of Maryland, College Park
Shepherd Center, Atlanta GA
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Principal Investigator: Paula R Geigle, PT, PhD Kernan Orthopaedics and Rehabilitation
Principal Investigator: Peter H Gorman, MD, FAAN University of Maryland, Baltimore

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Paula Geigle, Assistant Professor, Neurology, University of Maryland, College Park Identifier: NCT01407354    
Other Study ID Numbers: HP-00047439
First Posted: August 2, 2011    Key Record Dates
Results First Posted: April 8, 2016
Last Update Posted: April 8, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Paula Geigle, University of Maryland, College Park:
robotic weight support
aquatic exercise
incomplete motor spinal cord injury
ASIA C and D
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System