Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06349434
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-01
Brief Title:
The Utilization Effects of Powered Wearable Orthotics in Improving Upper Extremity Function and ADL in Persons With SCI
Sponsor:
Kessler Foundation
Organization:
Kessler Foundation
Study Overview
Official Title:
The Utilization Effects of Powered Wearable Orthotics in Improving Upper Extremity Function and ADL in Persons With SCI
Status:
RECRUITING
Status Verified Date:
2024-04
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:
To evaluate the usefulness of an upper extremity assistive device called MyoPro in improving upper extremity activities in people with incomplete spinal cord injury The Department of Defense is supporting this study
Detailed Description:
Spinal cord injury SCI is a medically complex and life-disrupting condition Each year in the United States it is estimated that 17700 new traumatic SCI cases are reported including many active service men and women and veterans About half of those the injury involve some part of the arm and hand representing significant disability and dependence for those patients and their families When armshands are impaired the patients quality of life and level of independence are reduced The proposed RCT investigation will evaluate the long-term effects of the UE-MPWO MyoPro in ameliorating wristhandUE movement capability and increasing ADL and quality of life in people with SCI This MyoPro orthosis can assist elbow and hand function with built-in motors that are activated by patients intended motion as represented by the residue voluntary muscle activities detected by the devices sensors
The impact of the data generated from this clinical trial investigation should advance the application of new orthotic and prosthetic technologies to treating disabilities as a result of injuries or diseases such as SCI and promote home and community uses of the technologies to improve daily function and independence The study would also advance scientific knowledge regarding neural changes occurring in the nervous system by application of the technology The learned knowledge from this investigation will further justify the utilization of such an orthotic technology for individuals with SCI
Beyond the common therapeutic benefits of upper extremity motor function rehabilitation and assistance for daily living provided with utilization of the MyoPro orthotic device there may be additional benefits including improvements in quality of life and activity of daily living due to recovered function by using the device The clinical trial investigation described in this application would provide clinicians and therapists with an initial but stronger basis for integrating such an orthosis into regimens for managing upper extremity impairments in persons with SCI This would represent a significant improvement to the existing paradigms of treating handarm disabilities in persons with SCI The benefits for the patients and society including the VA community of utilizing such an orthotic device during daily activities at home and in the community far outweigh the minimal risks associated with this FDA-approved orthosis particularly as those minimal risks have been minimized by using sound research methodologies
The impact of the data generated from this clinical trial investigation should advance the application of new orthotic and prosthetic technologies to treating disabilities as a result of injuries or diseases such as SCI and promote home and community uses of the technologies to improve daily function and independence The study would also advance scientific knowledge regarding neural changes occurring in the nervous system by application of the technology The learned knowledge from this investigation will further justify the utilization of such an orthotic technology for individuals with SCI
Beyond the common therapeutic benefits of upper extremity motor function rehabilitation and assistance for daily living provided with utilization of the MyoPro orthotic device there may be additional benefits including improvements in quality of life and activity of daily living due to recovered function by using the device The clinical trial investigation described in this application would provide clinicians and therapists with an initial but stronger basis for integrating such an orthosis into regimens for managing upper extremity impairments in persons with SCI This would represent a significant improvement to the existing paradigms of treating handarm disabilities in persons with SCI The benefits for the patients and society including the VA community of utilizing such an orthotic device during daily activities at home and in the community far outweigh the minimal risks associated with this FDA-approved orthosis particularly as those minimal risks have been minimized by using sound research methodologies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None