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Stroke Wearable Operative Rehabilitation Device Impact Trial (SWORD-IT)

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ClinicalTrials.gov Identifier: NCT01967290
Recruitment Status : Completed
First Posted : October 22, 2013
Last Update Posted : November 28, 2013
Sponsor:
Information provided by (Responsible Party):
Vítor Tedim Cruz, Centro Hospitalar de Entre o Douro e Vouga

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Ischemic Stroke Upper Extremity Hemiparesis Device: Vibratory feedback and 3D movement analysis Device: Only 3D movement analysis Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of the Impact of the SWORD Device on Rehabilitation Tasks Performance in the Early Post Stroke Period
Study Start Date : May 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: Vibratory feedback and 3D movement analysis
Hand-to-mouth task performed under vibratory feedback combined with 3D continuous movement analysis.
Other Names:
  • Propriocetive actuation
  • Vibratory stimulation
  • SWORD
  • Stroke Wearable Operative Rehabilitation Device
Active Comparator: 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.
 Device: Only 3D movement analysis
Hand-to-mouth task performed under 3D continuous movement analysis only
Other Names:
  • 3D movement quantification
  • 3D movement characterization
  • SWORD
  • Stroke Wearable Operative Rehabilitation Device


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Total number of movements [ Time Frame: At the end of each hand-to-mouth task. ]
    Total number of correct and incorrect movements performed within the duration of each hand-to-mouth task.

  2. Range of motion in degrees [ Time Frame: At the end of each hand-to-mouth task. ]
    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.

  3. Time between correct movements in seconds [ Time Frame: At the end of each hand-to-mouth task. ]
    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.

  4. Cumulative amplitude of correct movements in degrees [ Time Frame: At the end of each hand-to-mouth task ]
    Sum of the amplitudes of all correct movements performed within the duration of each hand-to-mouth task.

  5. Cumulative amplitude of all movements performed in degrees [ Time Frame: At the end of each hand-to-mouth task. ]
    Sum of the amplitudes of all correct and incorrect movements performed within the duration of each hand-to-mouth task.

  6. Number of pause events during the task [ Time Frame: At the end of each hand-to-mouth 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.

  7. Fatigue [ Time Frame: At the end of each hand-to-mouth task. ]
    Assessment of fatigue by the patient through an analogic scale from 0 (no fatigue) to 4 (interruption due to fatigue).

  8. Pain [ Time Frame: At the end of each hand-to-mouth task. ]
    Assessment of pain by the patient through an analogic scale from 0 (no pain) to 4 (interruption due to pain).

  9. Number and type of other distresses [ Time Frame: At the end of each hand-to-mouth task. ]
    Recording and description of any kind of discomfort reported by the patient or detected through vital parameter and arterial oxygen saturation monitoring.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;
  • 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:

  • 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;
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967290


Locations
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Portugal
Rehabilitation Department, Centro Hospitalar do Alto Ave, EPE
Guimarães, Portugal, 4835-044
Neurology Department, CHEDV
Santa Maria da Feira, Portugal, 4520-211
Rehabilitation Department, CHEDV
Santa Maria da Feira, Portugal, 4520-211
Sponsors and Collaborators
Centro Hospitalar de Entre o Douro e Vouga
Investigators
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Principal Investigator: Vítor T. Cruz, MD Centro Hospitalar de Entre o Douro e Vouga
Study Chair: Paula Coutinho, PhD IBMC - University of Oporto
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Vítor Tedim Cruz, MD, Centro Hospitalar de Entre o Douro e Vouga
ClinicalTrials.gov Identifier: NCT01967290    
Other Study ID Numbers: PTDC/SAU-NEU/102075/2008_SWORD
First Posted: October 22, 2013    Key Record Dates
Last Update Posted: November 28, 2013
Last Verified: November 2013
Keywords provided by Vítor Tedim Cruz, Centro Hospitalar de Entre o Douro e Vouga:
stroke
motor deficits
motor rehabilitation
neurorehabilitation
 medical devices
wearable devices
e-health systems
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations