Effects of Robotic Versus Manually-Assisted Locomotor Training for Individuals With Incomplete Spinal Cord Injury (DE)

VA Office of Research and Development

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Other: Robotic Assisted Locomotor Training; Procedure: Manually Assisted Locomotor Training

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00127439

B4024-I

Details and patient eligibility

About

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 with spinal cord injury (SCI).

Full 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 intensive step training on a treadmill using body-weight support (BWS) 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 (LT) 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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 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, 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Robotic Assisted Locomotor Training

Experimental group

Description:

A robotic stepping device in concert with a body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. The robotic device provides the appropriate kinematics associated with standing and stepping.

Treatment:

Other: Robotic Assisted Locomotor Training

Manually Assisted Locomotor Training

Experimental group

Description:

A body weight support system and treadmill is used by a physical therapist and trainers for the participant with spinal cord injury to intensely practice task-specific standing and stepping to advance retraining the capacity to step. Therapists and trainers promote the appropriate kinematics associated with standing and stepping.

Treatment:

Procedure: Manually Assisted Locomotor Training