Ischemic StrokeSWORD-ITNCT01967290

Stroke Wearable Operative Rehabilitation Device Impact Trial

A study testing Vibratory feedback and 3D movement analysis and Only 3D movement analysis in people with Ischemic Stroke and Upper Extremity Hemiparesis, run by Centro Hospitalar de Entre o Douro e Vouga at 3 sites in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Ischemic Stroke, Upper Extremity Hemiparesis
What is being tested?: Vibratory feedback and 3D movement analysis and Only 3D movement analysis
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 3 sitesPortugal
Study dates: May 2013to Nov 2013
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

More than 18 years old at stroke onset, with no superior age limit;
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;

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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.

Who cannot join

No detectable motor deficits at baseline assessment by the neurologist;
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;

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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.

Trial locations and contacts

3 sites in 1 country.

Portugal3 sites

Rehabilitation Department, Centro Hospitalar do Alto Ave, EPE
Guimarães, 4835-044
Neurology Department, CHEDV
Santa Maria da Feira, 4520-211
Rehabilitation Department, CHEDV
Santa Maria da Feira, 4520-211

Other trials in Portugal

About this study

Official title: Phase II Study of the Impact of the SWORD Device on Rehabilitation Tasks Performance in the Early Post Stroke Period

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.

Conditions: Ischemic Stroke, Upper Extremity Hemiparesis
Being tested: Vibratory feedback and 3D movement analysis, Only 3D movement analysis
Keywords: stroke, motor deficits, motor rehabilitation, neurorehabilitation, medical devices, wearable devices, e-health systems
Medical subject headings: Ischemic Stroke, Stroke, Neurologic Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vibratory feedback and 3D movement analysisDevice
Also called Propriocetive actuation, Vibratory stimulation, SWORD, Stroke Wearable Operative Rehabilitation Device
Hand-to-mouth task performed under vibratory feedback combined with 3D continuous movement analysis.
Only 3D movement analysisDevice
Also called 3D movement quantification, 3D movement characterization, SWORD, Stroke Wearable Operative Rehabilitation Device
Hand-to-mouth task performed under 3D continuous movement analysis only

Study groups in NCT01967290
Study group	Role	What they receive
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. Receives: Device: Vibratory feedback and 3D movement analysis
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. Receives: Device: Only 3D movement analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of correct movements
Number of correct movements performed within the duration of each hand-to-mouth task.
Measured: At the end of each hand-to-mouth task.

Secondary outcomes (9)

Total number of movements
Total number of correct and incorrect movements performed within the duration of each hand-to-mouth task.
Measured: At the end of each hand-to-mouth task.
Range of motion in degrees
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: At the end of each hand-to-mouth task.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Nov 2013

First posted22 Oct 2013 (estimated)
Study startMay 2013
Primary completionOct 2013
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Ischemic StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01967290
Sponsor's protocol ID: PTDC/SAU-NEU/102075/2008_SWORD
Acronym: SWORD-IT
Status last verified: Nov 2013
First submitted: 18 Oct 2013
Last updated: 28 Nov 2013
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 22672942
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.
PubMed 22255572
Bento VF, Cruz VT, Ribeiro DD, Colunas MM, Cunha JP. The SWORD tele-rehabilitation system. Stud Health Technol Inform. 2012;177:76-81.
PubMed 22942034
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.
PubMed 23879761
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.
PubMed 25011667

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study of the Impact of the SWORD Device on Rehabilitation Tasks Performance in the Early Post Stroke Period
ClinicalTrials.gov ID: NCT01967290
Acronym / sponsor ID: SWORD-IT / PTDC/SAU-NEU/102075/2008_SWORD
Conditions: Ischemic Stroke, Upper Extremity Hemiparesis
Keywords: stroke, motor deficits, motor rehabilitation, neurorehabilitation, medical devices, wearable devices, e-health systems
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Centro Hospitalar de Entre o Douro e VougaUniversity, hospital or other
Study start: May 2013
Primary completion: Oct 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 22 Oct 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The investigators hypothesize that vibratory stimuli during a motor rehabilitation task increase significantly the number of correct movements performed per unit of time.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Hand-to-mouth task - vibratory feedback	Experimental	Device: Vibratory feedback and 3D movement analysisHand-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	Device: Only 3D movement analysisHand-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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

More than 18 years old at stroke onset, with no superior age limit;
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;

Key exclusion criteria (9 listed)

No detectable motor deficits at baseline assessment by the neurologist;
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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vibratory feedback and 3D movement analysisAlso: Propriocetive actuation, Vibratory stimulation, SWORD, Stroke Wearable Operative Rehabilitation DeviceHand-to-mouth task performed under vibratory feedback combined with 3D continuous movement analysis.	Device	Hand-to-mouth task - vibratory feedback
Only 3D movement analysisAlso: 3D movement quantification, 3D movement characterization, SWORD, Stroke Wearable Operative Rehabilitation DeviceHand-to-mouth task performed under 3D continuous movement analysis only	Device	Hand-to-mouth task - no vibratory feedback

Primary outcome

Number of correct movements
Time frame: At the end of each hand-to-mouth task.
Number of correct movements performed within the duration of each hand-to-mouth task.

9 secondary outcomes

Total number of movements
Time frame: At the end of each hand-to-mouth task.
Range of motion in degrees
Time frame: At the end of each hand-to-mouth task.
Time between correct movements in seconds
Time frame: At the end of each hand-to-mouth task.
Cumulative amplitude of correct movements in degrees
Time frame: At the end of each hand-to-mouth task
Cumulative amplitude of all movements performed in degrees
Time frame: At the end of each hand-to-mouth task.
Number of pause events during the task
Time frame: At the end of each hand-to-mouth task
Fatigue
Time frame: At the end of each hand-to-mouth task.
Pain
Time frame: At the end of each hand-to-mouth task.
Number and type of other distresses
Time frame: At the end of each hand-to-mouth task.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
Background: PubMed 22672942Bento 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.
Background: PubMed 22255572Bento 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.
Background: PubMed 22942034Bento VF, Cruz VT, Ribeiro DD, Colunas MM, Cunha JP. The SWORD tele-rehabilitation system. Stud Health Technol Inform. 2012;177:76-81.
Background: PubMed 23879761Bento 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.
Derived from this study: PubMed 25011667Cruz 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.

Related trials for Ischemic Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
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Biomarkers of Paired VNS
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vítor T. Cruz, MD principal investigator

Centro Hospitalar de Entre o Douro e Vouga

Paula Coutinho, PhD study chair

IBMC - University of Oporto

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of correct movements (time frame: At the end of each hand-to-mouth task.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01967290, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2013.