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| Name | Class |
|---|---|
| CMM - Centro Médico da Murtosa | UNKNOWN |
| CMM - Centro Médico de Aveiro | UNKNOWN |
| Centro Médico de Viseu | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SWORD and exercise with biofeedback | Experimental | 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. |
|
| SWORD and exercise without biofeedback | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SWORD | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of repetitions | Total number of repetitions performed within the duration of each exercise session | At the end of each exercise session (4 minute duration) |
| Number of incorrect repetitions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando D Correia, MD | Sword Health, SA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMM - Murtosa | Murtosa | Aveiro District | 3870-216 | Portugal | ||
| CMM - Centro Médico de Aveiro |
Individual Participant Data will not be made available to other researchers
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D001676 | Biofeedback, Psychology |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
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| Exercise with biofeedback | Other |
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| exercise without biofeedback | Other |
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Number of incorrect repetitions performed within the duration of each exercise session
| At the end of each exercise session (4 minute duration) |
| Number of consecutive incorrect repetitions | Number of consecutive incorrect repetitions performed within the duration of each exercise session | At the end of each exercise session (4 minute duration) |
| Number of pauses | Number of pauses registered during each exercise session | At the end of each exercise session (4 minute duration) |
| Posture errors | Number of posture errors registered during each exercise session | At the end of each exercise session (4 minute duration) |
| Movement frequency | Movement frequency (in Hertz) during each exercise session | At the end of each exercise session (4 minute duration) |
| Range of motion of correct movements | Mean range of motion of the correct movements performed during each exercise session | At the end of each exercise session (4 minute duration) |
| Range of motion variability over time | Variability of the mean range of motion during the exercise session (for correct movements) | Between the second and first minute; between the second and third minutes; between the third and fourth minute |
| Aveiro |
| Portugal |
| CMM- Centro Médico de Viseu | Viseu | 3500-719 | Portugal |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |