Robotically Assisted Treadmill Training in Spinal Cord Injury (SCI)

Learn more about:
Related Clinical Trial
Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury Retraining Walking After Spinal Cord Injury Spinal Cord Injury Exercise and Nutrition Conceptual Engagement Body Composition Assessment in Spinal Cord Injury Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study Medico-economical Impact of the Brindley Neurosurgical Technique in France Evaluation of Safety and Performance of the Atalante System With Patients With Lower Limb Paralysis The Safety of ahSC in Chronic SCI With Rehabilitation Evaluation of an Advanced Lower Extremity Neuroprostheses Natural History of Shoulder Pathology in Manual Wheelchair Users Correlation Between Pressure Differences and Micro-vascularization Changes in Bedridden Paraplegic Patient Quantification of the Pressure Threshold Related to Tissue Injury in Bedriden Paraplegics Functional Electrical Stimulation With Rowing as Exercise After Spinal Cord Injury Spinal Cord Injury Leg Rehabilitation Multimodal Exercises to Improve Leg Function After Spinal Cord Injury A Neuroprosthesis for Prolonged Standing After SCI Using Multi-Contact Peripheral Nerve Electrodes A Neuroprosthesis for Seated Posture and Balance Robotically Assisted Treadmill Training in Spinal Cord Injury (SCI) Functional Electrical Stimulation Cycling in SCI Exoskeletal-assisted Walking to Improve Mobility, Bowel Function and Cardio-Metabolic Profiles in Persons With SCI Study of the Impact of the Use of a Corset on the Respiratory Function of Patients With Spinal Cord Injury Exercise to Reduce Obesity in Spinal Cord Injury Interactive Telehealth for Wheelchair Users The Feasibility and Effects of Low-load Blood-flow Restricted Exercise Following Spinal Cord Injury Evaluation of a Power Assistance Device for Wheelchair-DUO Assessment of Vasomotion of People With Spinal Cord Injury Adjusting Wheelchair Set-Up to Minimize Shoulder Joint Forces During Propulsion ExoAtlet II For SCI Patients Safety and Performance Evaluation of ReWalk Reciprocating Gait Orthosis (RGO) Pressure Ulcer Formation Prevention in Paraplegics Using Computer and Sensory Substitution Via the Tongue. Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit High-intensity Interval Training for Cardiometabolic Health in Persons With Spinal Cord Injury High-intensity Interval Training and Mixed Meal Responses in Persons With Spinal Cord Injury The ReWalk Exoskeletal Walking System for Persons With Paraplegia Gait Training for Individuals With Paraplegia Using the H-MEX Exoskeleton Training With Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion for Patients With Chronic Complete Paraplegia Evaluation of a Hybrid Prototype Strategy (Electrostimulation of Lower Limb Muscles Associated With Voluntary Strengthening of the Upper Limbs) in Reconditioning to Effort in Patients With Chronic Paraplegia.

Brief Title

Robotically Assisted Treadmill Training in Spinal Cord Injury (SCI)

Official Title

Cardiovascular Parameters for Lokomat Training in Chronic Incomplete SCI

Brief Summary

      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
    

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.
    


Study Type

Interventional


Primary Outcome

Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments

Secondary Outcome

 Body Mass

Condition

Paraplegia

Intervention

Lokomat Training

Study Arms / Comparison Groups

 Lokomat training
Description:  Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

18

Start Date

October 2006

Completion Date

June 2011

Primary Completion Date

June 2011

Eligibility 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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Peter Gorman, MD MS, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00385918

Organization ID

B4027

Secondary IDs

B40271

Responsible Party

Sponsor

Study Sponsor

US Department of Veterans Affairs

Collaborators

 University of Maryland, College Park

Study Sponsor

Peter Gorman, MD MS, Principal Investigator, VA Maryland Health Care System, Baltimore


Verification Date

April 2014