Ignite Creation Date:
2024-05-06 @ 4:21 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04964635
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2021-06-23
Brief Title:
TETRAGRIP II - Usability Trial of an FES Orthosis for People With Tetraplegia
Sponsor:
Bournemouth University
Organization:
Bournemouth University
Study Overview
Official Title:
TETRAGRIP II - Usability Trial of an FES Orthosis for People With Tetraplegia
Status:
COMPLETED
Status Verified Date:
2022-11
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:
Functional Electrical Stimulation is an established technique in which small electrical impulses are used to cause a contraction in muscles and thereby enable movement in people with neurological or musculoskeletal problems who are unable to undertake those movements themselves People with spinal cord injuries of the neck at C5 C6 and C7 account for 35 of all spinal cord injuries Despite this there is only one commercial FES Functional Electrical Stimulation based orthosis currently available Even that has limitations in that it as it has a single size rigid exoskeleton it does not fit all people who could benefit and also due to its rigidity it does not allow people with lower injuries to utilise any remaining tenodesis grip As a result it is not widely used within the spinal injured communities Therefore what is required is a more flexible system that can benefit a larger number of people whilst still being affordable within the constraints of the NHS A previous INSPIRE funded project TETRAGRIP I demonstrated that a surface FES system controlled by an inertial sensor measuring movement of the opposite shoulder could meet this specification and was successfully tried on two people with tetraplegia What is now required is a more detailed study in which the principle components of that system are incorporated into a practical device suitable for use at home without clinical supervision It is therefore proposed to develop and build such a system and to conduct extended home based trials in three people with tetraplegia
Detailed Description:
None
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