Effects of Robotic Versus Manually-Assisted Locomotor Training for Individuals With Incomplete Spinal Cord Injury (DE)
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Purpose
| Condition | Intervention |
|---|---|
|
Spinal Cord Injuries |
Procedure: Manually Assisted Locomotor Training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Differential Effects of Robotic vs. Manually-Assisted Locomotor Training |
- Trunk and Limb Kinematics [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | June 2005 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1 |
Procedure: Manually Assisted Locomotor Training
Individuals will receive 45 sessions of robotic or manually assisted locomotor training. The goal for each training session is to walk for no more than 30 minutes.
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults at least 18 years of age
- SCI 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, 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00127439
| United States, Florida | |
| North Florida/South Georgia Veterans Health System | |
| Gainesville, Florida, United States, 32608 | |
| Principal Investigator: | Andrea Behrman, PT PhD | North Florida/South Georgia Veterans Health System |
More Information
Additional Information:
Publications:
| Responsible Party: | VA Office of Research and Development |
| ClinicalTrials.gov Identifier: | NCT00127439 History of Changes |
| Other Study ID Numbers: | B4024-I |
| Study First Received: | August 3, 2005 |
| Last Updated: | September 17, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by VA Office of Research and Development:
|
Ambulatory Disability Disability Ambulation Locomotion Disorders |
Motor Activity Rehabilitation Spinal Cord Injury |
Additional relevant MeSH terms:
|
Wounds and Injuries Spinal Cord Injuries Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System |
ClinicalTrials.gov processed this record on September 30, 2016