Status:
COMPLETED
Effects of Robotic Versus Manually-Assisted Locomotor Training for Individuals With Incomplete Spinal Cord Injury
Lead Sponsor:
VA Office of Research and Development
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to collect data comparing two means of providing locomotor training: manual and robotic and the possible differential effects it may have on walking ability for persons wi...
Detailed Description
Spinal cord injury (SCI) is one of the most disabling health problems facing adults today, with one of the consequences often being inability to walk or difficulty walking. Recent studies suggest that...
Eligibility Criteria
Inclusion
- Adults at least 18 years of age
- Spinal cord injury (SCO) at least 6 months since injury
- Motor I-SCI, upper motor neuron lesion only at cervical or thoracic levels
- A diagnosis of first time SCI including etiology from trauma, vascular, or orthopedic pathology
- SCI as defined by the American ASIA Impairment Scale categories C or D
- Medically stable condition that is asymptomatic for bladder infection, decubiti, osteoporosis, cardiopulmonary disease, pain, contractures or other significant medical complications that would prohibit or interfere with testing of walking function and training or alter compliance with the training protocol
- Documented medical approval from the participant's personal physician verifying the participant's medical status at time of enrollment
- Ability to walk a minimum of 30 feet with or without an assistive device, independently or with minimal assistance
- Over ground gait speed \< 0.8 m/s
- Persons using anti-spasticity medication must maintain stable medication dosage during the study
- Able to give informed consent
Exclusion
- Current participation in a rehabilitation program/research protocol that could interfere or influence the outcome measures of the current study
- History of congenital SCI (e.g. myelomeningocele, intraspinal neoplasm, Friedreich's ataxia) or other degenerative spinal disorders (e.g. spinocerebellar degeneration, syringomyelia) that may complicate the protocol
- Inappropriate or unsafe fit of the harness or robotic trainer due to the participant's body size and/or joint contractures or severe spasticity that would prohibit the safe provision of either training modality
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00127439
Start Date
June 1 2005
End Date
April 1 2009
Last Update
January 24 2018
Active Locations (1)
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1
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608