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

Sword Health, SA30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ischemic Stroke Upper Extremity Paresis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.