Robotically Assisted Treadmill Training in Spinal Cord Injury (SCI)

This study has been completed.
Sponsor:
Collaborators:
University of Maryland
Kernan Orthopaedics and Rehabilitation Hospital
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00385918
First received: October 6, 2006
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

This proposal investigates the hypothesis that progressive aerobic exercise with Lokomat is feasible in people with motor incomplete spinal cord injury, and three months of training will improve cardiovascular fitness and gait functionality when compared to physical therapy controls


Condition Intervention
Paraplegia
Quadriplegia
Spinal Cord Injury
Tetraplegia
Device: Lokomat Training
Other: Home stretching then Lokomat training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cardiovascular Parameters for Lokomat Training in Chronic Incomplete SCI

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments [ Time Frame: 0, 1.5 and 3, 4.5, and 6 months ] [ Designated as safety issue: No ]

    Peak V02 measurements taken during Lokomat exercise in order to measure cardiovascular fitness.

    Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.


  • Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments. [ Time Frame: 0, 1.5 and 3, 4.5, and 6 months ] [ Designated as safety issue: No ]

    Peak oxygen consumption during arm cycle ergometry as a measure of cardiovascular fitness.

    Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.



Secondary Outcome Measures:
  • Body Mass [ Time Frame: Measured at Baseline (Time point 0), 3, and 6 months ] [ Designated as safety issue: No ]

    DXA assessment of total body mass.

    Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.


  • Percent Body Fat [ Time Frame: Measured at Baseline (Time point 0), 3, and 6 months ] [ Designated as safety issue: No ]

    An assessment of percent body fat as determined by DXA analysis.

    Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.


  • Lean Muscle Mass [ Time Frame: Measured at Baseline (Time point 0) and 3 months ] [ Designated as safety issue: No ]

    DXA measurement of total lean muscle mass.

    Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.


  • Bone Mineral Content [ Time Frame: Measured at Baseline (Time point 0), 3, and 6 months ] [ Designated as safety issue: No ]

    DXA assessment of bone mineral content.

    Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.


  • Six Minute Walk [ Time Frame: Measured Baseline (Time point 0) and 3 months ] [ Designated as safety issue: No ]

    A functional capacity test to evaluate walking distance during a 6-minute time frame.

    This measure was only done on those participants that were able to walk for 6 minutes, which represented 9 in the Lokomat training group out of the 12 total randomized to Lokomat training, and 5 out of the 6 randomized to the home stretching group.

    Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.


  • 10-meter Walk [ Time Frame: Measured at Baseline (Time point 0) and 3 months ] [ Designated as safety issue: No ]

    A functional capacity test to measure speed.

    This measure was only done on those participants that were able to walk, which represented 9 in the Lokomat training group out of the 12 total randomized to Lokomat training, and 5 out of the 6 who were randomized to home stretching.

    Note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.


  • Step Activity Monitor [ Time Frame: Measured at Baseline (Time point 0) and 3 months ] [ Designated as safety issue: No ]

    The step activity monitor measures the total steps taken by an individual over a 48 hour time frame in the home environment.

    This measure was only done on those participants that were able to walk in the community and did not use a wheelchair for community mobility, which represented 7 in the Lokomat training group out of the 12 total randomized to Lokomat training and 5 out of 6 of the people randomized to home stretching.

    Please note that at times the home stretching group would have a second set of measurements at 3 months - one post the 3 month time interval and one later in the 3rd month if there was some delay in initiating the crossover to Lokomat training. This sometimes occurred if the time it would take to complete all of the required studies (e.g. DXA, other secondary measures) was prolonged because of logistical issues.



Enrollment: 18
Study Start Date: October 2006
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lokomat training
Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.
Device: Lokomat Training
The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis.
Active Comparator: Home stretching then Lokomat training
Patients will participate in a home stretching program for 3 months. They will then be crossed over to an active Lokomat treatment for a subsequent 3 months.
Other: Home stretching then Lokomat training
Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm. After 3 months the patients will be crossed over to Lokomat training for an additional 3 months. This training will be the same as given to the individuals originally randomized to the Lokomat treatment intervention.

Detailed Description:

Little information is available about the cardiovascular effects of robotically assisted partial weight support treadmill training devices such as Lokomat in chronic incomplete spinal cord injured subjects. Task-oriented aerobic exercise has the potential to improve both neuromuscular function and cardiovascular metabolic fitness in neurological populations. Since spinal cord injured individuals are at an increased risk of developing premature cardiovascular disease, the investigation of robotic-assisted interventions in spinal cord injury (SCI) such as the Lokomat may have important health benefits in both cardiovascular fitness as well as functional mobility.

This proposal investigates the hypothesis that progressive aerobic exercise with Lokomat is feasible in motor incomplete SCI, and three months of training will improve cardiovascular fitness and gait functionality when compared to physical therapy controls. We propose a two-phase study to examine the feasibility, reliability and utility of aerobic exercise metabolic testing and training during robotically assisted partial weight support treadmill walking in individuals with chronic motor incomplete spinal cord injury (CMISCI). During the first phase of the study we will manipulate Lokomat training parameters of treadmill speed and percent of partial weight support to assess the effect of these changes on heart rate, perceived exertion, and oxygen consumption in untrained chronic motor incomplete spinal cord injured subjects. Subjects will be asked to maintain cardiovascular or muscular effort during testing and will be monitored in this regard by the force biofeedback system built into the Lokomat. After determining threshold levels for initial cardiovascular response, submaximal and then peak exercise testing will be attempted. These studies will be repeated on a separate day to determine the reliability of the testing results. Thirty-six subjects with varying levels of injury between C4 and L2 and ASIA (American Spinal Injury) Impairment Scales of C and D will be recruited. We anticipate that subjects with greater ASIA motor scores will require either a faster initial treadmill speed or less partial weight support to produce an initial cardiovascular response. It is also anticipated that peak exercise testing using open circuit spirometry with subjects on the Lokomat will be a feasible, reliable and valid measurement. This phase of the study will be aimed at establishing guidelines for determining initial training parameters for use in an aerobic exercise protocol using the Lokomat.

The second phase of this pilot study will be a controlled trial of three-month progressive aerobic Lokomat exercise in chronic incomplete spinal cord injured subjects. The aim of this trial will be to determine whether progressive Lokomat training will improve cardiovascular fitness and ambulatory function when compared to matched impairment severity CMISCI subjects receiving the same duration of usual physical therapy care. Thirty-six subjects will be recruited into this phase of the study. Open spirometric evaluation of cardiovascular parameters as outlined in phase one of the proposal will be measured at baseline, 1 months, and 3 months. Initial, six-week and post-study ambulatory function evaluations including the WISCI (Walking Index for Spinal Cord Injury), a timed 10 meter walk, a measured walk over 6 minutes, and a gait analysis will also be determined. It is hypothesized that aerobic Lokomat exercise will improve cardiovascular fitness as determined by an increase in VO2 (oxygen consumption) peak and improve function as determined by timed walks and gait parameters in these subjects. The results of this pilot and development study will provide the necessary information to design larger randomized clinical trials.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute onset Spinal Cord Injury or Disease at least 12 months prior to enrollment
  • Age 18 to 80
  • Level of injury from C4 to L2
  • ASIA impairment scale either C or D
  • Able to tolerate standing frame for at least 30 minutes

Exclusion Criteria:

  • History of unstable angina, recent MI (myocardial infarction), CHF (congestive heart failure) or clinically significant valvular dysfunction
  • History of recent hospitalization (<3 months) for a major medical problem
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385918

Locations
United States, Maryland
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201
University of Maryland Rehabilitation and Orthopaedic Institute
Baltimore, Maryland, United States, 21207
Sponsors and Collaborators
University of Maryland
Kernan Orthopaedics and Rehabilitation Hospital
Investigators
Principal Investigator: Peter Gorman, MD MS VA Maryland Health Care System, Baltimore
  More Information

Additional Information:
Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00385918     History of Changes
Other Study ID Numbers: B4027, B40271, HP-00042597
Study First Received: October 6, 2006
Results First Received: November 12, 2013
Last Updated: April 11, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Cardiovascular Fitness
Exercise
Gait
Spinal Cord Injury
Treadmill Training

Additional relevant MeSH terms:
Spinal Cord Injuries
Paraplegia
Quadriplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 29, 2014