Robotically Assisted Treadmill Training in Spinal Cord Injury (SCI)

NCT00385918 | Completed Results DMC

• 3 other identifiers: B4027B40271HP-00042597
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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

Conditions

Paraplegia; Quadriplegia; Spinal Cord Injury; Tetraplegia

Keywords

Cardiovascular Fitness; Exercise; Gait; Spinal Cord Injury; Treadmill Training

Outcome Measures

Primary Outcomes (2)

• Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments

  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.

  0, 1.5 and 3, 4.5, and 6 months

• Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments.

  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.

  0, 1.5 and 3, 4.5, and 6 months

Secondary Outcomes (7)

• Body Mass

  Measured at Baseline (Time point 0), 3, and 6 months

• Percent Body Fat

  Measured at Baseline (Time point 0), 3, and 6 months

• Lean Muscle Mass

  Measured at Baseline (Time point 0) and 3 months

• Bone Mineral Content

  Measured at Baseline (Time point 0), 3, and 6 months

• Six Minute Walk

  Measured Baseline (Time point 0) and 3 months

Study Arms (2)

Lokomat training

EXPERIMENTAL

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

Home stretching then Lokomat training

ACTIVE COMPARATOR

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

Interventions

Lokomat Training DEVICE

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.

Lokomat training

Home stretching then Lokomat training OTHER

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.

Home stretching then Lokomat training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• University of Maryland: collaborator
• Kernan Orthopaedics and Rehabilitation Hospital: collaborator

Study Sites (2)

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, United States

Location

University of Maryland Rehabilitation and Orthopaedic Institute

Baltimore, Maryland, 21207, United States

Location

Related Publications (2)

• Gorman PH, Geigle PR, Chen K, York H, Scott W. Reliability and relatedness of peak VO2 assessments during body weight supported treadmill training and arm cycle ergometry in individuals with chronic motor incomplete spinal cord injury. Spinal Cord. 2014 Apr;52(4):287-91. doi: 10.1038/sc.2014.6. Epub 2014 Feb 18.

  PMID: 24534779 RESULT

• Gorman PH, Scott W, York H, Theyagaraj M, Price-Miller N, McQuaid J, Eyvazzadeh M, Ivey FM, Macko RF. Robotically assisted treadmill exercise training for improving peak fitness in chronic motor incomplete spinal cord injury: A randomized controlled trial. J Spinal Cord Med. 2016;39(1):32-44. doi: 10.1179/2045772314Y.0000000281. Epub 2014 Dec 18.

  PMID: 25520035 DERIVED

Related Links

• Website of the manufacturer of the Lokomat
• Hospital where the research is being undertaken.

MeSH Terms

Conditions

Paraplegia; Quadriplegia; Spinal Cord Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Limitations and Caveats

1. Skin irritation caused missed sessions. 2. Attendance rates were lower than desired given medical and transportation factors. 3. No clearly defined exclusion criteria for bone density in individuals with SCI using this type intervention.

Results Point of Contact

• Title: Peter H. Gorman, MD Chief Division of Rehabilitation Medicine
• Organization: University of Maryland Rehabiitation and Orthopaedic Institute

pgorman@umm.edu

410-448-6261

Study Officials

• Peter Gorman, MD MS

  VA Maryland Health Care System, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2006
• First Posted: October 11, 2006
• Study Start: October 1, 2006
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 14, 2014
• Results First Posted: May 14, 2014

Record last verified: 2014-04

Locations

US (2)