Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964829
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2023-07-18
Brief Title:
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
Sponsor:
Cionic Inc
Organization:
Cionic Inc
Study Overview
Official Title:
A Crossover Study Evaluating the Impact of the Cionic Neural Sleeve on Mobility Disability Fall Risk and Physical Activity in Multiple Sclerosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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 purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis MS
Detailed Description:
The randomized within-participants crossover study aims to demonstrate the clinical impact of the Cionic Neural Sleeve for individuals diagnosed with MS
Physical measurements performance-based tests and questionnaire responses will be recorded These include physical activity recorded by an Actigraph in-person tests measuring disability spasticity and balance and questionnaires gauging perceived walking ability quality of life and physical and psychological impact of MS
All participants will be assigned a hip-worn Actigraph activity monitor a Cionic Neural Sleeve on the most impacted leg and prescribed a home-based intervention of 15 minutes of walking for 5 days a week for 12 weeks The Actigraph will be worn for the duration of the 12-week walking intervention while the Cionic Neural Sleeve will be worn for 6 weeks of the study
Participants will be randomized to one of two groups A or B Group A will wear the Actigraph and receive stimulation assisted walking from the Neural Sleeve intervention while group B will only wear the Actigraph while walking After 6 weeks participants in each group will cross over to the other group
Physical measurements performance-based tests and questionnaire responses will be recorded These include physical activity recorded by an Actigraph in-person tests measuring disability spasticity and balance and questionnaires gauging perceived walking ability quality of life and physical and psychological impact of MS
All participants will be assigned a hip-worn Actigraph activity monitor a Cionic Neural Sleeve on the most impacted leg and prescribed a home-based intervention of 15 minutes of walking for 5 days a week for 12 weeks The Actigraph will be worn for the duration of the 12-week walking intervention while the Cionic Neural Sleeve will be worn for 6 weeks of the study
Participants will be randomized to one of two groups A or B Group A will wear the Actigraph and receive stimulation assisted walking from the Neural Sleeve intervention while group B will only wear the Actigraph while walking After 6 weeks participants in each group will cross over to the other group
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?:
False
Is an FDA AA801 Violation?:
None