Stroke Wearable Operative Rehabilitation Device Impact Trial
NCT ID: NCT01967290
Last Updated: 2013-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2013-05-31
2013-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Hand-to-mouth task - vibratory feedback
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.
Vibratory feedback and 3D movement analysis
Hand-to-mouth task performed under vibratory feedback combined with 3D continuous movement analysis.
Hand-to-mouth task - no vibratory feedback
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.
Only 3D movement analysis
Hand-to-mouth task performed under 3D continuous movement analysis only
Interventions
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Vibratory feedback and 3D movement analysis
Hand-to-mouth task performed under vibratory feedback combined with 3D continuous movement analysis.
Only 3D movement analysis
Hand-to-mouth task performed under 3D continuous movement analysis only
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Medical diagnosis of acute ischemic stroke;
* First ever stroke;
* Previously independent, defined as having a modified Rankin scale (mRS) of 0-1;
* Clinical and CT or MRI compatible with a medial cerebral artery ischemic lesion;
* Confirmed motor deficit on the upper limb but not plegia (able to actively extend wrist, thumb, and at least 2 other digits \>10°), defined as a score between 0 and 2 on items 5a or 5b of the National Institute of Health Stroke Scale;
* Inpatients, within no more than 4 weeks after stroke onset;
* Medically stable, no intravenous medication and already able to sit for more than one hour comfortably;
* Favourable opinion of the attending stroke physician;
* Patient and caregiver understand the purpose of the study and provided written informed consent.
Exclusion Criteria
* Severe aphasia;
* Dementia (any stage);
* Other cognitive or psychiatric comorbidity that impairs communication or compliance with the tasks;
* Severe respiratory or cardiac condition incompatible with more than one minute of continuous mild exercise (e.g. combing hair) in a sitting position;
* Pain that limits upper limb movement either on the normal or affected side;
* Upper limb amputation or severe deformity either on the normal or affected side;
* Fixed articular limitations of upper limb either on the normal or affected side;
* Enrollment in other trial in the previous 3 months.
18 Years
ALL
No
Sponsors
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Centro Hospitalar de Entre o Douro e Vouga
OTHER
Responsible Party
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Vítor Tedim Cruz
MD
Principal Investigators
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Vítor T. Cruz, MD
Role: PRINCIPAL_INVESTIGATOR
Centro Hospitalar de Entre o Douro e Vouga
Paula Coutinho, PhD
Role: STUDY_CHAIR
IBMC - University of Oporto
Locations
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Rehabilitation Department, Centro Hospitalar do Alto Ave, EPE
Guimarães, , Portugal
Neurology Department, CHEDV
Santa Maria da Feira, , Portugal
Rehabilitation Department, CHEDV
Santa Maria da Feira, , Portugal
Countries
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References
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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.
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.
Other Identifiers
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PTDC/SAU-NEU/102075/2008_SWORD
Identifier Type: -
Identifier Source: org_study_id