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

May 6, 2021 updated by: Peter Gorman, University of Maryland, Baltimore

Lokomat and Aquatic Therapy in Chronic Motor Incomplete Spinal Cord Injury

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30309-1465
        • Shepherd Center, Virginia C. Crawford Research Institute
    • Maryland
      • Baltimore, Maryland, United States, 21207
        • University of Maryland Rehabilitation & Orthopaedic Institute (formerly known as Kernan Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Aquatic Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

Shepherd Center, Atlanta GA

Investigators

  • Principal Investigator: Paula R Geigle, PT, PhD, University of Maryland Rehabilitation and Orthopaedic Institute
  • Principal Investigator: Peter H Gorman, MD, FAAN, University of Maryland, Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

July 12, 2011

First Submitted That Met QC Criteria

July 31, 2011

First Posted (Estimate)

August 2, 2011

Study Record Updates

Last Update Posted (Actual)

May 26, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00047439
  • SC090147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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