Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-02-20 @ 1:43 PM
Study NCT ID:
NCT03032692
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2017-01-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motor Task Performance Under Visual and Auditory Feedback Post Stroke: a Randomized Crossover Trial
Sponsor:
Sword Health, SA
Organization:
Study Overview
Official Title:
Motor Task Performance Under Visual and Auditory Feedback Post Stroke: a Randomized Crossover Trial
Status:
COMPLETED
Status Verified Date:
2017-06
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 study was designed to evaluate the impact of a novel kinematic biofeedback system - SWORD - in the motor performance of patients after stroke. The SWORD system combines inertial motion trackers and a mobile app, allowing digitization of patient motion and providing real-time audiovisual biofeedback.
The investigators hypothesize that the biofeedback feedback provided by the SWORD system improves patient performance, defined as an increase in the number of correct movements.
The design of the study is a cross-over randomized clinical trial. Patients will be randomized into two groups. Both will perform two separate sessions consisting of one exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in both experimental settings: with and without biofeedback. Group 1 will perform the exercise with biofeedback first and without biofeedback after, with an interval \>24h. Group 2 will perform the exercise in the opposite order. The SWORD system will be used to record movement data in both sessions, but the feedback was only active in one of them.
The investigators hypothesize that the biofeedback feedback provided by the SWORD system improves patient performance, defined as an increase in the number of correct movements.
The design of the study is a cross-over randomized clinical trial. Patients will be randomized into two groups. Both will perform two separate sessions consisting of one exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in both experimental settings: with and without biofeedback. Group 1 will perform the exercise with biofeedback first and without biofeedback after, with an interval \>24h. Group 2 will perform the exercise in the opposite order. The SWORD system will be used to record movement data in both sessions, but the feedback was only active in one of them.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: