The purpose of this study is to collect data regarding the various aspects of locomotor training and how it affects different people with spinal cord injury (SCI).

Condition	Intervention
Spinal Cord Injuries	Procedure: Manually Assisted Locomotor Training

Further Study Details: 

Primary Outcomes: Participants will undergo a series of pre-training evaluations, followed by 9 weeks of training, and repeat the evaluations at the completion of training; Four primary outcome measures: propulsion; transition; stepping; and equilibrium represent critical sub-tasks to the control of walking. These measures will be based on biomechanical testing and analyses (ie: treadmill designed to record bilateral ground reaction forces; motion analysis; and dynamic equilibrium during body-weight supported walking).
Secondary Outcomes: Additional outcome measures for participants will also be performed the week before and the week following completion of the nine weeks of training. These evaluations will include: American Spinal Injury Association (ASIA) Classification of Impairment
Expected Total Enrollment:  96

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 intensive step training on a treadmill using body-weight support and manual assistance that provides repetitive task-specific sensory cues to the neural axis can improve the recovery of walking for persons with incomplete SCI. More recently, robotics have been developed as an alternative to manually-assisted training. Robotic-assisted training may allow for increased intensity of training, improve the reproducibility and consistency of training, and reduce the personnel needed to implement the training. However, the effects of robotic-assisted training compared to manually-assisted training are not known. An improved understanding of these differential effects and the mechanisms of improvement in walking can facilitate continued advances in evidenced-based practice of neuro-rehabilitation, therefore improving the treatment of persons with SCI.

The primary objective of this project is to assess and compare the effects of robotic-assisted versus manually-assisted locomotor training using the body-weight support (BWS) on sub-tasks of walking. Specifically, we believe that at least four sub-tasks of walking are differentially affected by the robotic-assisted training when compared to manually-assisted training (propulsion, transition from stance to step, stepping, and equilibrium). The investigators hypothesize that robotic-assisted training will have a greater effect on improving propulsion, transition and equilibrium. The effect of these two modalities on adaptability, a fifth sub-task of walking, is unclear; therefore, a development component of the pilot project will involve establishing a quantitative measure of adaptability and assessing differential effects of training.

Participants will be randomized to one of two training groups: robotic-assisted or manually-assisted, and evaluated for performance on sub-tasks of walking.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Adults age 18-65 years
• SCI within 6 months to 5 years
• 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 Criteria:

• 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, Frederich’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

Please refer to this study by ClinicalTrials.gov identifier  NCT00127439

Florida
      Malcom Randall VA Medical Center, Gainesville,  Florida,  32608,  United States; Recruiting

Study chairs or principal investigators

Andrea Behrman, PT PhD,  Principal Investigator,  VA RR&D Brain rehabilitation Research Center of Excellence   

Study ID Numbers:  B4024
Last Updated:  August 22, 2005
Record first received:  August 3, 2005
ClinicalTrials.gov Identifier:  NCT00127439
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23