Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06137456
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2023-11-14
Brief Title:
First Report of a New Exoskeleton in Incomplete Spinal Cord Injury
Sponsor:
Ankara City Hospital Bilkent
Organization:
Ankara City Hospital Bilkent
Study Overview
Official Title:
First Report of a New Exoskeleton in Incomplete Spinal Cord Injury FreeGait
Status:
COMPLETED
Status Verified Date:
2023-11
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:
None
Brief Summary:
The goal of this clinical trial is to compare the effects of exoskeletal robotic therapy and conventional exercise therapy in incomplete spinal cord injury SCI The main questions it aims to answer are
Is exoskeletal robotic therapy effective in improving functional ambulation in SCI
Is exoskeletal robotic therapy effective in enhancing Activities of Daily Living in SCI
Participants treated with either
Exoskeletal robotic therapy along with conventional exercise therapy or
Only conventional exercise therapy
Is exoskeletal robotic therapy effective in improving functional ambulation in SCI
Is exoskeletal robotic therapy effective in enhancing Activities of Daily Living in SCI
Participants treated with either
Exoskeletal robotic therapy along with conventional exercise therapy or
Only conventional exercise therapy
Detailed Description:
Background Intensive walking practice is a task that requires performance above the limits of conventional therapy As a solution robot-assisted exoskeletons that allow walking on the ground are produced The exoskeletons can allow the user to perform intense targeted and multi-repetitive movements and at the same time provide stability and balance during walking In this study a new robot-supported exoskeleton system was used for gait and balance rehabilitation This study is important as the first clinical study of a new walking system The primary aim of the study was to evaluate the effect of the FreeGait exoskeleton system BAMA Technology Ankara Türkiye on gait parameters in patients with motor incomplete spinal cord injury The secondary aim was to assess its impact on quality of life and independence
Methods Fourteen participants with incomplete spinal cord injury were included in the study An average of 207 sessions of exoskeleton therapy was administered to the study group Gait training was attempted to be diversified as much as possible during the exoskeleton training 10MWT Timed Up and Go Test TUG WISCI II Berg Balance Scale BBS Visual Analogue Scale VAS for fear of falling Spinal Cord Independence Measure SCIM III World Health Organization Quality of Life Scale-Short Form WHOQOL - BREF were used for evaluation
Results WISCI II levels improved significantly in the study group p 0031 Overground walking speed means calculated from 10MWT increased by 66 twofold compared to the control group p 0016 p 0063 respectively The mobility subscale of SCIM III the total SCIM III scores and the WHOQOL-BREF physical health domain score increased significantly contrary to the control group p 005 However there was no difference in the mean change of all measurements between groups p 005
Conclusions Gait training with the new exoskeleton system contributes to functional walking skills It is possible that the residual motor learning ability together with the balance and compensation mechanisms played a role in the outcome It is also important that this improvement in functional mobility is reflected in ADLs It can be supposed that walking in different patterns and speeds gives a way to simulate daily living conditions which is the basis of the achievements in this study
Methods Fourteen participants with incomplete spinal cord injury were included in the study An average of 207 sessions of exoskeleton therapy was administered to the study group Gait training was attempted to be diversified as much as possible during the exoskeleton training 10MWT Timed Up and Go Test TUG WISCI II Berg Balance Scale BBS Visual Analogue Scale VAS for fear of falling Spinal Cord Independence Measure SCIM III World Health Organization Quality of Life Scale-Short Form WHOQOL - BREF were used for evaluation
Results WISCI II levels improved significantly in the study group p 0031 Overground walking speed means calculated from 10MWT increased by 66 twofold compared to the control group p 0016 p 0063 respectively The mobility subscale of SCIM III the total SCIM III scores and the WHOQOL-BREF physical health domain score increased significantly contrary to the control group p 005 However there was no difference in the mean change of all measurements between groups p 005
Conclusions Gait training with the new exoskeleton system contributes to functional walking skills It is possible that the residual motor learning ability together with the balance and compensation mechanisms played a role in the outcome It is also important that this improvement in functional mobility is reflected in ADLs It can be supposed that walking in different patterns and speeds gives a way to simulate daily living conditions which is the basis of the achievements in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None