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

Not Applicable

Completed

• Conditions: Ischemic Stroke; Upper Extremity Paresis

• Registration Number: NCT03032692
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-01
• Primary Completion: 2016-08-31
• Study Completion: 2016-08-31
• Study First Submitted: 2017-01-24
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-26
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-12
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Number of correct movements	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

Name	Time	Method
Number of incorrect repetitions	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	At the end of each exercise session (4 minute duration)	Number of consecutive incorrect repetitions performed within the duration of each exercise session
Total number of repetitions	At the end of each exercise session (4 minute duration)	Total number of repetitions performed within the duration of each exercise session
Range of motion of correct movements	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	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)
Number of pauses	At the end of each exercise session (4 minute duration)	Number of pauses registered during each exercise session
Posture errors	At the end of each exercise session (4 minute duration)	Number of posture errors registered during each exercise session
Movement frequency	At the end of each exercise session (4 minute duration)	Movement frequency (in Hertz) during each exercise session

Trial Locations

Locations (3)

CMM - Murtosa; 🇵🇹 Murtosa, Aveiro, Portugal

CMM - Centro Médico de Aveiro; 🇵🇹 Aveiro, Portugal

CMM- Centro Médico de Viseu; 🇵🇹 Viseu, Portugal