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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

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.


Condition or disease Intervention/treatment Phase
Ischemic Stroke Upper Extremity Paresis Device: SWORD Other: Exercise with biofeedback Other: exercise without biofeedback Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Motor Task Performance Under Visual and Auditory Feedback Post Stroke: a Randomized Crossover Trial
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : August 31, 2016
Actual Study Completion Date : August 31, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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
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.
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 without biofeedback



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Number of pauses [ Time Frame: At the end of each exercise session (4 minute duration) ]
    Number of pauses registered during each exercise session

  5. Posture errors [ Time Frame: At the end of each exercise session (4 minute duration) ]
    Number of posture errors registered during each exercise session

  6. Movement frequency [ Time Frame: At the end of each exercise session (4 minute duration) ]
    Movement frequency (in Hertz) during each exercise session

  7. 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

  8. 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)



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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:

  • 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.

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): NCT03032692


Locations
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Portugal
CMM - Murtosa
Murtosa, Aveiro, Portugal, 3870-216
CMM - Centro Médico de Aveiro
Aveiro, Portugal
CMM- Centro Médico de Viseu
Viseu, Portugal, 3500-719
Sponsors and Collaborators
Sword Health, SA
CMM - Centro Médico da Murtosa
CMM - Centro Médico de Aveiro
Centro Médico de Viseu
Investigators
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Principal Investigator: Fernando D Correia, MD Sword Health, SA
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

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Responsible Party: Sword Health, SA
ClinicalTrials.gov Identifier: NCT03032692    
Other Study ID Numbers: RCT-BFK01
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual Participant Data will not be made available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations