Clinical trial NCT00127439: Effects of Robotic Versus Manually-Assisted Locomotor Training for Individuals With Incomplete Spinal Cord Injury
Official title: Differential Effects of Robotic vs. Manually-Assisted Locomotor Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Ambulatory Disability
Disability Ambulation
Locomotion Disorders
Motor Activity
Rehabilitation
Spinal Cord Injury
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-08-05
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 with spinal cord injury (SCI).

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Self Selected Velocity on Treadmill
timeFrame: 12 weeks
measure: Stepping: Foot Trajectory Toe-Off
timeFrame: 12 weeks
measure: Stepping: Foot Trajectory Toe-off % Cycle
timeFrame: 12 weeks
measure: Foot Trajectory Initial Contact
timeFrame: 12 weeks
measure: Foot Trajectory Range (Toe Off to Heel Strike)
timeFrame: 12 weeks
measure: Propulsion: Propulsive Impulse
timeFrame: 12 weeks
measure: Kinematics: Minimum Thigh Angle
timeFrame: 12 weeks
measure: Kinematics: Minimum Hip Angle - Extension
timeFrame: 12 weeks
measure: Kinematics: Trunk Angle Mid-Stance
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System
name: Andrea Behrman, PT PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Behrman AL, Harkema SJ. Locomotor training after human spinal cord injury: a series of case studies. Phys Ther. 2000 Jul;80(7):688-700.
citation: Barbeau H, Norman K, Fung J, Visintin M, Ladouceur M. Does neurorehabilitation play a role in the recovery of walking in neurological populations? Ann N Y Acad Sci. 1998 Nov 16;860:377-92. doi: 10.1111/j.1749-6632.1998.tb09063.x.
citation: Hesse S, Uhlenbrock D. A mechanized gait trainer for restoration of gait. J Rehabil Res Dev. 2000 Nov-Dec;37(6):701-8.
citation: Colombo G, Joerg M, Schreier R, Dietz V. Treadmill training of paraplegic patients using a robotic orthosis. J Rehabil Res Dev. 2000 Nov-Dec;37(6):693-700.
citation: Hornby TG, Zemon DH, Campbell D. Robotic-assisted, body-weight-supported treadmill training in individuals following motor incomplete spinal cord injury. Phys Ther. 2005 Jan;85(1):52-66.
citation: Trimble MH, Behrman AL, Flynn SM, Thigpen MT, Thompson FJ. Acute effects of locomotor training on overground walking speed and H-reflex modulation in individuals with incomplete spinal cord injury. J Spinal Cord Med. 2001 Summer;24(2):74-80. doi: 10.1080/10790268.2001.11753558.
citation: Day KV, Kautz SA, Wu SS, Suter SP, Behrman AL. Foot placement variability as a walking balance mechanism post-spinal cord injury. Clin Biomech (Bristol). 2012 Feb;27(2):145-50. doi: 10.1016/j.clinbiomech.2011.09.001. Epub 2011 Oct 14.