Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Department of Veterans Affairs |
---|---|
Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00127439 |
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 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Differential Effects of Robotic vs. Manually-Assisted Locomotor Training |
Estimated Enrollment: | 96 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 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.
|
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 and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | Department of Veterans Affairs ( Behrman, Andrea - Principal Investigator ) |
Study ID Numbers: | B4024I |
Study First Received: | August 3, 2005 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00127439 |
Health Authority: | United States: Federal Government |
Ambulatory Disability Disability Ambulation Locomotion Disorders |
Motor Activity Rehabilitation Spinal Cord Injury |
Spinal Cord Injuries Spinal Cord Diseases Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |
Nervous System Diseases |