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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke; Upper Extremity Paresis
• Intervention / Treatment: Device: SWORD; Other: Exercise with biofeedback; Other: exercise without biofeedback

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Aveiro, Portugal
    • CMM - Centro Médico de Aveiro
  • Viseu, Portugal, 3500-719
    • CMM- Centro Médico de Viseu
  • Aveiro
    • Murtosa, Aveiro, Portugal, 3870-216
      • CMM - Murtosa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Stroke Wearable Operative Rehabilitation Device; Other: exercise without biofeedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of correct movements	Number of correct movements performed within the duration of each exercise session	At the end of each exercise session (4 minute duration)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of repetitions	Total number of repetitions performed within the duration of each exercise session	At the end of each exercise session (4 minute duration)
Number of incorrect repetitions	Number of incorrect repetitions performed within the duration of each exercise session	At the end of each exercise session (4 minute duration)
Number of consecutive incorrect repetitions	Number of consecutive incorrect repetitions performed within the duration of each exercise session	At the end of each exercise session (4 minute duration)
Number of pauses	Number of pauses registered during each exercise session	At the end of each exercise session (4 minute duration)
Posture errors	Number of posture errors registered during each exercise session	At the end of each exercise session (4 minute duration)
Movement frequency	Movement frequency (in Hertz) during each exercise session	At the end of each exercise session (4 minute duration)
Range of motion of correct movements	Mean range of motion of the correct movements performed during each exercise session	At the end of each exercise session (4 minute duration)
Range of motion variability over time	Variability of the mean range of motion during the exercise session (for correct movements)	Between the second and first minute; between the second and third minutes; between the third and fourth minute

Collaborators and Investigators

• Sponsor: Sword Health, SA
• Collaborators: CMM - Centro Médico da Murtosa; CMM - Centro Médico de Aveiro; Centro Médico de Viseu
• Investigators: Principal Investigator: Fernando D Correia, MD, Sword Health, SA

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): August 31, 2016
• Study Completion (Actual): August 31, 2016

Study Registration Dates

• First Submitted: January 24, 2017
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (Estimate): January 26, 2017

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 12, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Ischemic Stroke; Paresis
• Other Study ID Numbers: RCT-BFK01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual Participant Data will not be made available to other researchers

Study Data/Documents

1. Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No