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

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.

Conditions

• Ischemic Stroke
• Upper Extremity Paresis

Interventions

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

Exercise with biofeedback

OTHER

exercise without biofeedback

Sponsors & Collaborators

• CMM - Centro Médico da Murtosa

  collaborator UNKNOWN

• CMM - Centro Médico de Aveiro

  collaborator UNKNOWN

• Centro Médico de Viseu

  collaborator UNKNOWN

• Sword Health, SA

  lead INDUSTRY

Principal Investigators

• Fernando D Correia, MD · Sword Health, SA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-01

Primary Completion

2016-08-31

Completion

2016-08-31

Countries

• Portugal

Study Locations