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

This study is currently recruiting participants.
Verified July 2011 by University of Maryland
Sponsor:
Collaborator:
Shepherd Center, Virginia C. Crawford Research Institute
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT01407354
First received: July 12, 2011
Last updated: July 31, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention Phase
Spinal Cord Injury
 Device: Lokomat treadmill training
Other: Aquatic exercise therapy
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lokomat and Aquatic Therapy in Chronic Motor Incomplete Spinal Cord Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Cardiovascular fitness assessment [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Arm Ergometer will be used to assess cardiovascular fitness


Secondary Outcome Measures:
  • Ambulatory function [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
    6-minute walk will be repeated 2 times to obtain average velocity


Estimated Enrollment: 36
Study Start Date: April 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lokomat Training
Lokomat robotic assisted 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01407354

Contacts
Contact: Paula R Geigle, PT, PhD 410-448-7164 pgeigle@kernan.umm.edu
Contact: William Scott, MS 410-448-6433 research@kernan.umm.edu

Locations
United States, Georgia
Shepherd Center, Virginia C. Crawford Research Institute Recruiting
Atlanta, Georgia, United States, 30309-1465
Contact: Leslie Vanhiel, MSPT     404-350-7681     Leslie_Vanhiel@shepherd.org    
Principal Investigator: Leslie Vanhiel, MSPT            
Principal Investigator: Keith Tansey, MD PhD            
United States, Maryland
Kernan Orthopedic and Rehabilitation Hospital Recruiting
Baltimore, Maryland, United States, 21207
Contact: Paula M Geigle, PT, PhD     410-448-7164     pgeigle@kernan.umm.edu    
Contact: William Scott, MS     410-448-6433     research@kernan.umm.edu    
Principal Investigator: Peter Gorman, MD            
Principal Investigator: Paula M Geigle, PT, PhD            
Sponsors and Collaborators
University of Maryland
Shepherd Center, Virginia C. Crawford Research Institute
Investigators
Principal Investigator: Paula R Geigle, PT, PhD Kernan Orthopaedics and Rehabilitation
Principal Investigator: Peter H Gorman, MD, FAAN University of Maryland, Baltimore County
  More Information

No publications provided

Responsible Party: Peter H. Gorman, MD, Kernan Orthopedic and Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01407354     History of Changes
Other Study ID Numbers: HP-00047439, SC090147
Study First Received: July 12, 2011
Last Updated: July 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
robotic weight support
aquatic exercise
incomplete motor spinal cord injury
ASIA C and D

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013