Sponsor study identifier
interventional
30
1 country
3
Study Start
June 1, 2016
Actual (reported)Primary Completion
August 31, 2016
Actual (reported)Study Completion
August 31, 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2016
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2016
Actual (reported)August 31, 2016
Actual (reported)August 31, 2016
Actual (reported)January 24, 2017
Actual (reported)January 26, 2017
Actual (reported)Number of correct movements
Number of correct movements performed within the duration of each exercise session
At the end of each exercise session (4 minute duration)
Total number of repetitions
At the end of each exercise session (4 minute duration)
Number of incorrect repetitions
At the end of each exercise session (4 minute duration)
Number of consecutive incorrect repetitions
At the end of each exercise session (4 minute duration)
Number of pauses
At the end of each exercise session (4 minute duration)
Posture errors
At the end of each exercise session (4 minute duration)
The patient will perform one repetition of the exercise shoulder flexion with elbow flexion at 90 degrees under monitoring from SWORD. The recorded parameters will be used to define: baseline and target angle; execution time; maximum postural sway. Two additional repetitions will be performed to ensure reproducibility. During the session, SWORD will be providing real-time audiovisual feedback. The patient has to start in the baseline position and fill the progress bar without violating movement or posture constraints. If the patient does not reach the goal or violates constraints he will receive a negative audio feedback, the progress bar will turn red and be reset. The patient has to return to the baseline position to restart the movement.
The patient will perform one repetition of the exercise shoulder flexion with elbow flexion at 90 degrees under monitoring from SWORD. The recorded parameters will be used to define: baseline and target angle; execution time; maximum postural sway. Two additional repetitions will be performed to ensure reproducibility. The patient will then be instructed to perform as many movements as possible during the allocated time (4 minutes), at a comfortable pace, starting at or below the baseline and trying to reach maximum flexion without significant pain or discomfort. During the session, the SWORD system will be recording the patient´s movement without providing feedback to the patient.
Both arms will perform two separate sessions consisting of one exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in two experimental conditions: with and without biofeedback. Group 1 will perform the exercise with biofeedback first and without biofeedback after; group 2 performed the exercise in the opposite order. The SWORD system will be used to record movement data in both sessions.
CMM - Murtosa
Murtosa, Aveiro District, 3870-216, Portugal
CMM - Centro Médico de Aveiro
Aveiro, Portugal
CMM- Centro Médico de Viseu
Viseu, 3500-719, Portugal
Fernando D Correia, MD
Sword Health, SA
30 participants (actual enrollment reported by the registry).
First Submitted
January 24, 2017
First Posted
January 26, 2017
Study Start
June 1, 2016
Actual (reported)Clinical Study of Cinepazide Maleate Injection in the Treatment of Acute Ischemic Stroke
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Primary Completion
August 31, 2016
Actual (reported)Study Completion
August 31, 2016
Actual (reported)Last Updated
June 14, 2017
Record last verified: 2017-06
Individual Participant Data will not be made available to other researchers
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Source: ClinicalTrials.gov.
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