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Motor Task Performance Under Visual and Auditory Feedback Post Stroke: a Randomized Crossover Trial

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ClinicalTrials.gov Identifier: NCT03032692
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborators:
CMM - Centro Médico da Murtosa
CMM - Centro Médico de Aveiro
Centro Médico de Viseu
Information provided by (Responsible Party):
Sword Health, SA

Tracking Information
First Submitted Date  ICMJE January 24, 2017
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date June 14, 2017
Actual Study Start Date  ICMJE June 1, 2016
Actual Primary Completion Date August 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
Number of correct movements [ Time Frame: At the end of each exercise session (4 minute duration) ]
Number of correct movements performed within the duration of each exercise session
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
  • Total number of repetitions [ Time Frame: At the end of each exercise session (4 minute duration) ]
    Total number of repetitions performed within the duration of each exercise session
  • Number of incorrect repetitions [ Time Frame: At the end of each exercise session (4 minute duration) ]
    Number of incorrect repetitions performed within the duration of each exercise session
  • Number of consecutive incorrect repetitions [ Time Frame: At the end of each exercise session (4 minute duration) ]
    Number of consecutive incorrect repetitions performed within the duration of each exercise session
  • Number of pauses [ Time Frame: At the end of each exercise session (4 minute duration) ]
    Number of pauses registered during each exercise session
  • Posture errors [ Time Frame: At the end of each exercise session (4 minute duration) ]
    Number of posture errors registered during each exercise session
  • Movement frequency [ Time Frame: At the end of each exercise session (4 minute duration) ]
    Movement frequency (in Hertz) during each exercise session
  • Range of motion of correct movements [ Time Frame: At the end of each exercise session (4 minute duration) ]
    Mean range of motion of the correct movements performed during each exercise session
  • Range of motion variability over time [ Time Frame: Between the second and first minute; between the second and third minutes; between the third and fourth minute ]
    Variability of the mean range of motion during the exercise session (for correct movements)
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 Motor Task Performance Under Visual and Auditory Feedback Post Stroke: a Randomized Crossover Trial
Official Title  ICMJE Motor Task Performance Under Visual and Auditory Feedback Post Stroke: a Randomized Crossover Trial
Brief Summary

The study was designed to evaluate the impact of a novel kinematic biofeedback system - SWORD - in the motor performance of patients after stroke. The SWORD system combines inertial motion trackers and a mobile app, allowing digitization of patient motion and providing real-time audiovisual biofeedback.

The investigators hypothesize that the biofeedback feedback provided by the SWORD system improves patient performance, defined as an increase in the number of correct movements.

The design of the study is a cross-over randomized clinical trial. Patients will be randomized into two groups. Both will perform two separate sessions consisting of one exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in both experimental settings: with and without biofeedback. Group 1 will perform the exercise with biofeedback first and without biofeedback after, with an interval >24h. Group 2 will perform the exercise in the opposite order. The SWORD system will be used to record movement data in both sessions, but the feedback was only active in one of them.

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 Paresis
Intervention  ICMJE
  • Device: SWORD
    Both arms will perform two separate sessions consisting of one exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in two experimental conditions: with and without biofeedback. Group 1 will perform the exercise with biofeedback first and without biofeedback after; group 2 performed the exercise in the opposite order. The SWORD system will be used to record movement data in both sessions.
    Other Name: Stroke Wearable Operative Rehabilitation Device
  • Other: Exercise with biofeedback
  • Other: exercise without biofeedback
Study Arms  ICMJE
  • Experimental: SWORD and exercise with biofeedback
    The patient will perform one repetition of the exercise shoulder flexion with elbow flexion at 90 degrees under monitoring from SWORD. The recorded parameters will be used to define: baseline and target angle; execution time; maximum postural sway. Two additional repetitions will be performed to ensure reproducibility. During the session, SWORD will be providing real-time audiovisual feedback. The patient has to start in the baseline position and fill the progress bar without violating movement or posture constraints. If the patient does not reach the goal or violates constraints he will receive a negative audio feedback, the progress bar will turn red and be reset. The patient has to return to the baseline position to restart the movement.
    Interventions:
    • Device: SWORD
    • Other: Exercise with biofeedback
  • Active Comparator: SWORD and exercise without biofeedback
    The patient will perform one repetition of the exercise shoulder flexion with elbow flexion at 90 degrees under monitoring from SWORD. The recorded parameters will be used to define: baseline and target angle; execution time; maximum postural sway. Two additional repetitions will be performed to ensure reproducibility. The patient will then be instructed to perform as many movements as possible during the allocated time (4 minutes), at a comfortable pace, starting at or below the baseline and trying to reach maximum flexion without significant pain or discomfort. During the session, the SWORD system will be recording the patient´s movement without providing feedback to the patient.
    Interventions:
    • Device: SWORD
    • Other: exercise without biofeedback
Publications * Not Provided

*   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: January 25, 2017)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 31, 2016
Actual Primary Completion Date August 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • clinical symptoms and signs and CT or MRI findings compatible with a lesion in the territory of the medial cerebral artery;
  • persistent motor deficit on the upper limb but not plegia with a score between 0 and 2 on item 5b of the National Institute of Health Stroke Scale (NIHSS)
  • more than 2 weeks after stroke onset;
  • the ability to sit comfortably for more than 10 minutes and perform two-step commands

Exclusion Criteria:

  • no detectable motor deficits at baseline assessment;
  • severe aphasia;
  • clinical dementia or mini mental state examination (MMSE) below cutoff;
  • other cognitive or psychiatric comorbidity that impaired communication or compliance with the tasks;
  • severe respiratory or cardiac condition incompatible with more than 5 minutes of continuous mild exercise in a sitting position;
  • pain or deformity that limited upper limb movement on the affected side.
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 NCT03032692
Other Study ID Numbers  ICMJE RCT-BFK01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual Participant Data will not be made available to other researchers
Responsible Party Sword Health, SA
Study Sponsor  ICMJE Sword Health, SA
Collaborators  ICMJE
  • CMM - Centro Médico da Murtosa
  • CMM - Centro Médico de Aveiro
  • Centro Médico de Viseu
Investigators  ICMJE
Principal Investigator: Fernando D Correia, MD Sword Health, SA
PRS Account Sword Health, SA
Verification Date June 2017

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