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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

Tracking Information
First Submitted Date  ICMJE October 18, 2013
First Posted Date  ICMJE October 22, 2013
Last Update Posted Date November 28, 2013
Study Start Date  ICMJE May 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2013)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stroke Wearable Operative Rehabilitation Device Impact Trial
Official Title  ICMJE Phase II Study of the Impact of the SWORD Device on Rehabilitation Tasks Performance in the Early Post Stroke Period
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ischemic Stroke
  • Upper Extremity Hemiparesis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: Vibratory feedback and 3D movement analysis
  • 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.
    Intervention: Device: Only 3D movement analysis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2013)
44
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2013)
50
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Portugal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01967290
Other Study ID Numbers  ICMJE PTDC/SAU-NEU/102075/2008_SWORD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Vítor Tedim Cruz, Centro Hospitalar de Entre o Douro e Vouga
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Centro Hospitalar de Entre o Douro e Vouga
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vítor T. Cruz, MD Centro Hospitalar de Entre o Douro e Vouga
Study Chair: Paula Coutinho, PhD IBMC - University of Oporto
PRS Account Centro Hospitalar de Entre o Douro e Vouga
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP