Ignite Creation Date:
2024-05-06 @ 4:12 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04900896
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-10
First Post:
2021-05-12
Brief Title:
Outcome Measures Study on an Adult Myoelectric Elbow-Wrist-Hand Orthosis
Sponsor:
Myomo
Organization:
Myomo
Study Overview
Official Title:
Outcome Measures Study on an Adult Myoelectric Elbow-Wrist-Hand Orthosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
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 objective of this study is to evaluate the therapeutic and functional gains of a myoelectric elbow-wrist-hand orthosis for adult individuals with upper limb impairments using repeated measures studies that combines both gross motion and quantitative function outcome measures
Detailed Description:
The objective of this study is to evaluate the therapeutic and functional gains of a myoelectric elbow-wrist-hand orthosis for adult individuals with upper limb impairments using repeated measures studies that combines both gross motion and quantitative function outcome measures
The primary outcomes of this study will collect data on the participants therapeutic and functional outcome measures when using the MyoPro over time in their home Baseline data without the device will be collected prior to receiving the MyoPro Data with and without the device will then be collected at 2-weeks post fitting and then at 1-month intervals thereafter for 12 months These outcome measures will enable an understanding of the participants functional gains with and without the MyoPro and over time with the MyoPro
The primary outcomes of this study will collect data on the participants therapeutic and functional outcome measures when using the MyoPro over time in their home Baseline data without the device will be collected prior to receiving the MyoPro Data with and without the device will then be collected at 2-weeks post fitting and then at 1-month intervals thereafter for 12 months These outcome measures will enable an understanding of the participants functional gains with and without the MyoPro and over time with the MyoPro
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