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The objective of this study is to determine the impact of vibratory feedback on the quality and intensity of a common motor rehabilitation task of the upper-arm (hand-to-mouth) in stroke patients. For that purpose the investigators use the SWORD system that combines 3D motion quantification wearable sensors and a vibratory module.
The investigators hypothesize that vibratory stimuli during a motor rehabilitation task increase significantly the number of correct movements performed per unit of time.
The design of the study is a cross-over randomized clinical trial. With the SWORD system in place each patient will perform the hand-to-mouth task twice (with vibratory feedback and without it), the order being random. The number of correct movements and other motor outcomes will be assessed continuously under both conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hand-to-mouth task - vibratory feedback | Experimental | Hand-to-mouth task under vibratory feedback and 3D movement analysis. The SWORD device is in place over the patient arm, performs continuous 3D movement analysis and provides vibratory feedback according to quality performance settings established by the clinician after patient assessment. If movement is of lower amplitude or slower than prescribed a vibratory stimulus is delivered at the wrist of the patient. The intervention is repeated on the hemiparetic and normal sides and the duration of the task is defined according to the patient cardiovascular status. |
|
| Hand-to-mouth task - no vibratory feedback | Active Comparator | Hand-to-mouth task in the same conditions as the experimental arm but without vibratory feedback, only 3D movement analysis. The SWORD device is in place over the patient arm, performs continuous 3D movement analysis but does not provides vibratory feedback according to quality performance settings established by the clinician after patient assessment. If movement is of lower amplitude or slower than prescribed NO vibratory stimulus is delivered at the wrist of the patient. The intervention is repeated on the hemiparetic and normal sides and the duration of the task is defined according to the patient cardiovascular status. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibratory feedback and 3D movement analysis | Device | Hand-to-mouth task performed under vibratory feedback combined with 3D continuous movement analysis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of correct movements | Number of correct movements performed within the duration of each hand-to-mouth task. | At the end of each hand-to-mouth task. |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of movements | Total number of correct and incorrect movements performed within the duration of each hand-to-mouth task. | At the end of each hand-to-mouth task. |
| Range of motion in degrees |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| VÃtor T. Cruz, MD | Centro Hospitalar de Entre o Douro e Vouga | Principal Investigator |
| Paula Coutinho, PhD | IBMC - University of Oporto | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Department, Centro Hospitalar do Alto Ave, EPE | Guimarães | 4835-044 | Portugal | |||
| Neurology Department, CHEDV |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22672942 | Background | Bento VF, Cruz VT, Ribeiro DD, Cunha JP. The vibratory stimulus as a neurorehabilitation tool for stroke patients: proof of concept and tolerability test. NeuroRehabilitation. 2012;30(4):287-93. doi: 10.3233/NRE-2012-0757. | |
| 22255572 | Background | Bento VF, Cruz VT, Ribeiro DD, Cunha JP. Towards a movement quantification system capable of automatic evaluation of upper limb motor function after neurological injury. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:5456-60. doi: 10.1109/IEMBS.2011.6091392. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| D009461 | Neurologic Manifestations |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Only 3D movement analysis | Device | Hand-to-mouth task performed under 3D continuous movement analysis only |
|
|
Average, standard deviation and variance of the range of motion, measured in degrees, of all the correct movements performed during the duration of each hand-to-mouth task.
| At the end of each hand-to-mouth task. |
| Time between correct movements in seconds | Average, standard deviation and variance of the time between correct movements, measured in seconds, of all the correct movements performed during the duration of each hand-to-mouth task. | At the end of each hand-to-mouth task. |
| Cumulative amplitude of correct movements in degrees | Sum of the amplitudes of all correct movements performed within the duration of each hand-to-mouth task. | At the end of each hand-to-mouth task |
| Cumulative amplitude of all movements performed in degrees | Sum of the amplitudes of all correct and incorrect movements performed within the duration of each hand-to-mouth task. | At the end of each hand-to-mouth task. |
| Number of pause events during the task | Number of episodes during the execution of each hand-to-mouth task where the patient stopped doing movements and/or the time between correct movements exceeded the mean plus one standard deviation measured within the same hand-to-mouth task. | At the end of each hand-to-mouth task |
| Fatigue | Assessment of fatigue by the patient through an analogic scale from 0 (no fatigue) to 4 (interruption due to fatigue). | At the end of each hand-to-mouth task. |
| Pain | Assessment of pain by the patient through an analogic scale from 0 (no pain) to 4 (interruption due to pain). | At the end of each hand-to-mouth task. |
| Number and type of other distresses | Recording and description of any kind of discomfort reported by the patient or detected through vital parameter and arterial oxygen saturation monitoring. | At the end of each hand-to-mouth task. |
| Santa Maria da Feira |
| 4520-211 |
| Portugal |
| Rehabilitation Department, CHEDV | Santa Maria da Feira | 4520-211 | Portugal |
| 22942034 | Background | Bento VF, Cruz VT, Ribeiro DD, Colunas MM, Cunha JP. The SWORD tele-rehabilitation system. Stud Health Technol Inform. 2012;177:76-81. |
| 23879761 | Background | Bento VF, Cruz VT, Ribeiro DD, Branco C, Coutinho P. The potential of motion quantification systems in the automatic evaluation of motor function after stroke. Int J Stroke. 2013 Aug;8(6):E37. doi: 10.1111/ijs.12111. No abstract available. |
| 25011667 | Derived | Cruz VT, Bento V, Ruano L, Ribeiro DD, Fontao L, Mateus C, Barreto R, Colunas M, Alves A, Cruz B, Branco C, Rocha NP, Coutinho P. Motor task performance under vibratory feedback early poststroke: single center, randomized, cross-over, controlled clinical trial. Sci Rep. 2014 Jul 11;4:5670. doi: 10.1038/srep05670. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |