NCT01967290|Completed
Stroke Wearable Operative Rehabilitation Device Impact Trial
SWORD-IT
Phase II Study of the Impact of the SWORD Device on Rehabilitation Tasks Performance in the Early Post Stroke Period
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SWORD-IT
Phase II Study of the Impact of the SWORD Device on Rehabilitation Tasks Performance in the Early Post Stroke Period
Sponsor study identifier
interventional
44
1 country
3
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2013
Actual (reported)Study Completion
November 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
October 2013
Actual (reported)October 18, 2013
Actual (reported)October 22, 2013
Actual (reported)November 2013
Actual (reported)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.
Total number of movements
At the end of each hand-to-mouth task.
Range of motion in degrees
At the end of each hand-to-mouth task.
Time between correct movements in seconds
At the end of each hand-to-mouth task.
Cumulative amplitude of correct movements in degrees
At the end of each hand-to-mouth task
Cumulative amplitude of all movements performed in degrees
At the end of each hand-to-mouth task.
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 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.
Hand-to-mouth task performed under vibratory feedback combined with 3D continuous movement analysis.
Hand-to-mouth task performed under 3D continuous movement analysis only
Rehabilitation Department, Centro Hospitalar do Alto Ave, EPE
Guimarães, 4835-044, Portugal
Neurology Department, CHEDV
Santa Maria da Feira, 4520-211, Portugal
Rehabilitation Department, CHEDV
Santa Maria da Feira, 4520-211, Portugal
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.
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.
Vítor T. Cruz, MD
Centro Hospitalar de Entre o Douro e Vouga
Paula Coutinho, PhD
IBMC - University of Oporto
44 participants (actual enrollment reported by the registry).
First Submitted
October 18, 2013
First Posted
October 22, 2013
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Head Position in Stroke Trial
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Bento VF, Cruz VT, Ribeiro DD, Colunas MM, Cunha JP. The SWORD tele-rehabilitation system. Stud Health Technol Inform. 2012;177:76-81.
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.
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.
Primary Completion
October 2013
Actual (reported)Study Completion
November 2013
Actual (reported)Last Updated
November 28, 2013
Record last verified: 2013-11
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Source: ClinicalTrials.gov.
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