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

Primary Purpose

Ischemic Stroke, Upper Extremity Paresis

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
SWORD
Exercise with biofeedback
exercise without biofeedback
Sponsored by
Sword Health, SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CMM - Murtosa
  • CMM - Centro Médico de Aveiro
  • CMM- Centro Médico de Viseu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SWORD and exercise with biofeedback

SWORD and exercise without biofeedback

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of correct movements
Number of correct movements performed within the duration of each exercise session

Secondary Outcome Measures

Total number of repetitions
Total number of repetitions performed within the duration of each exercise session
Number of incorrect repetitions
Number of incorrect repetitions performed within the duration of each exercise session
Number of consecutive incorrect repetitions
Number of consecutive incorrect repetitions performed within the duration of each exercise session
Number of pauses
Number of pauses registered during each exercise session
Posture errors
Number of posture errors registered during each exercise session
Movement frequency
Movement frequency (in Hertz) during each exercise session
Range of motion of correct movements
Mean range of motion of the correct movements performed during each exercise session
Range of motion variability over time
Variability of the mean range of motion during the exercise session (for correct movements)

Full Information

First Posted
January 24, 2017
Last Updated
June 12, 2017
Sponsor
Sword Health, SA
Collaborators
CMM - Centro Médico da Murtosa, CMM - Centro Médico de Aveiro, Centro Médico de Viseu
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1. Study Identification

Unique Protocol Identification Number
NCT03032692
Brief Title
Motor Task Performance Under Visual and Auditory Feedback Post Stroke: a Randomized Crossover Trial
Official Title
Motor Task Performance Under Visual and Auditory Feedback Post Stroke: a Randomized Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
August 31, 2016 (Actual)
Study Completion Date
August 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sword Health, SA
Collaborators
CMM - Centro Médico da Murtosa, CMM - Centro Médico de Aveiro, Centro Médico de Viseu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Upper Extremity Paresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SWORD and exercise with biofeedback
Arm Type
Experimental
Arm Description
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.
Arm Title
SWORD and exercise without biofeedback
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SWORD
Other Intervention Name(s)
Stroke Wearable Operative Rehabilitation Device
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise with biofeedback
Intervention Type
Other
Intervention Name(s)
exercise without biofeedback
Primary Outcome Measure Information:
Title
Number of correct movements
Description
Number of correct movements performed within the duration of each exercise session
Time Frame
At the end of each exercise session (4 minute duration)
Secondary Outcome Measure Information:
Title
Total number of repetitions
Description
Total number of repetitions performed within the duration of each exercise session
Time Frame
At the end of each exercise session (4 minute duration)
Title
Number of incorrect repetitions
Description
Number of incorrect repetitions performed within the duration of each exercise session
Time Frame
At the end of each exercise session (4 minute duration)
Title
Number of consecutive incorrect repetitions
Description
Number of consecutive incorrect repetitions performed within the duration of each exercise session
Time Frame
At the end of each exercise session (4 minute duration)
Title
Number of pauses
Description
Number of pauses registered during each exercise session
Time Frame
At the end of each exercise session (4 minute duration)
Title
Posture errors
Description
Number of posture errors registered during each exercise session
Time Frame
At the end of each exercise session (4 minute duration)
Title
Movement frequency
Description
Movement frequency (in Hertz) during each exercise session
Time Frame
At the end of each exercise session (4 minute duration)
Title
Range of motion of correct movements
Description
Mean range of motion of the correct movements performed during each exercise session
Time Frame
At the end of each exercise session (4 minute duration)
Title
Range of motion variability over time
Description
Variability of the mean range of motion during the exercise session (for correct movements)
Time Frame
Between the second and first minute; between the second and third minutes; between the third and fourth minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando D Correia, MD
Organizational Affiliation
Sword Health, SA
Official's Role
Principal Investigator
Facility Information:
Facility Name
CMM - Murtosa
City
Murtosa
State/Province
Aveiro
ZIP/Postal Code
3870-216
Country
Portugal
Facility Name
CMM - Centro Médico de Aveiro
City
Aveiro
Country
Portugal
Facility Name
CMM- Centro Médico de Viseu
City
Viseu
ZIP/Postal Code
3500-719
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual Participant Data will not be made available to other researchers
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://drive.google.com/file/d/0B2kmuI2zObfcMVhZYWhpdm9fRUE/view?usp=sharing

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

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