Ischemic Stroke, Upper Extremity Paresis
Conditions
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.
Interventions
DEVICESWORD
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.
OTHERExercise with biofeedback
OTHERexercise without biofeedback
Sponsors
CMM - Centro Médico da Murtosa
CMM - Centro Médico de Aveiro
Centro Médico de Viseu
Sword Health, SA
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Number of pauses | At the end of each exercise session (4 minute duration) | Number of pauses registered during 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 |
| Movement frequency | At the end of each exercise session (4 minute duration) | Movement frequency (in Hertz) during 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) |
| Posture errors | At the end of each exercise session (4 minute duration) | Number of posture errors registered during each exercise session |
Countries
Portugal
Outcome results
None listed