Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127439
Status:
COMPLETED
Last Update Posted:
2018-01-24
First Post:
2005-08-03
Brief Title:
Effects of Robotic Versus Manually-Assisted Locomotor Training for Individuals With Incomplete Spinal Cord Injury
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Differential Effects of Robotic vs Manually-Assisted Locomotor Training
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DE
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None