Clinical trial NCT03032692: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Upper Extremity Paresis
Lead sponsor: Sword Health, SA
Sponsor class: INDUSTRY
Collaborators: name: CMM - Centro Médico da Murtosa
name: CMM - Centro Médico de Aveiro
name: Centro Médico de Viseu
First posted: 2017-01-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of correct movements
timeFrame: At the end of each exercise session (4 minute duration)
Secondary outcomes:
measure: Total number of repetitions
timeFrame: At the end of each exercise session (4 minute duration)
measure: Number of incorrect repetitions
timeFrame: At the end of each exercise session (4 minute duration)
measure: Number of consecutive incorrect repetitions
timeFrame: At the end of each exercise session (4 minute duration)
measure: Number of pauses
timeFrame: At the end of each exercise session (4 minute duration)
measure: Posture errors
timeFrame: At the end of each exercise session (4 minute duration)
measure: Movement frequency
timeFrame: At the end of each exercise session (4 minute duration)
measure: Range of motion of correct movements
timeFrame: At the end of each exercise session (4 minute duration)
measure: Range of motion variability over time
timeFrame: Between the second and first minute; between the second and third minutes; between the third and fourth minute
Other outcomes:
Locations:
city: Murtosa
country: Portugal
facility: CMM - Murtosa
state: Aveiro
city: Aveiro
country: Portugal
facility: CMM - Centro Médico de Aveiro
city: Viseu
country: Portugal
facility: CMM- Centro Médico de Viseu
Study officials:
affiliation: Sword Health, SA
name: Fernando D Correia, MD
role: PRINCIPAL_INVESTIGATOR
References: