Motor Task Performance Under Visual and Auditory Feedback Post Stroke: a Randomized Crossover Trial

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • SWORD Device
    Other Names: Stroke Wearable Operative Rehabilitation Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: SWORD and exercise with biofeedback
    Description: 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.
    ARM 2: Kind: Experimental
    Label: SWORD and exercise without biofeedback
    Description: 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.
  • Exercise with biofeedback Other
    ARM 1: Kind: Experimental
    Label: SWORD and exercise with biofeedback
    Description: 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.
  • Exercise without biofeedback Other
    ARM 1: Kind: Experimental
    Label: SWORD and exercise without biofeedback
    Description: 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of correct movements At the end of each exercise session (4 minute duration)
Secondary Total number of repetitions At the end of each exercise session (4 minute duration)
Secondary Number of incorrect repetitions At the end of each exercise session (4 minute duration)
Secondary Number of consecutive incorrect repetitions At the end of each exercise session (4 minute duration)
Secondary Number of pauses At the end of each exercise session (4 minute duration)
Secondary Posture errors At the end of each exercise session (4 minute duration)
Secondary Movement frequency At the end of each exercise session (4 minute duration)
Secondary Range of motion of correct movements At the end of each exercise session (4 minute duration)
Secondary Range of motion variability over time Between the second and first minute; between the second and third minutes; between the third and fourth minute

Sponsors