Ischemic Stroke, Upper Extremity Hemiparesis
Conditions
Keywords
stroke, motor deficits, motor rehabilitation, neurorehabilitation, medical devices, wearable devices, e-health systems
Brief summary
The objective of this study is to determine the impact of vibratory feedback on the quality and intensity of a common motor rehabilitation task of the upper-arm (hand-to-mouth) in stroke patients. For that purpose the investigators use the SWORD system that combines 3D motion quantification wearable sensors and a vibratory module. The investigators hypothesize that vibratory stimuli during a motor rehabilitation task increase significantly the number of correct movements performed per unit of time. The design of the study is a cross-over randomized clinical trial. With the SWORD system in place each patient will perform the hand-to-mouth task twice (with vibratory feedback and without it), the order being random. The number of correct movements and other motor outcomes will be assessed continuously under both conditions.
Interventions
DEVICEVibratory feedback and 3D movement analysis
Hand-to-mouth task performed under vibratory feedback combined with 3D continuous movement analysis.
DEVICEOnly 3D movement analysis
Hand-to-mouth task performed under 3D continuous movement analysis only
Sponsors
Centro Hospitalar de Entre o Douro e Vouga
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
* More than 18 years old at stroke onset, with no superior age limit; * Medical diagnosis of acute ischemic stroke; * First ever stroke; * Previously independent, defined as having a modified Rankin scale (mRS) of 0-1; * Clinical and CT or MRI compatible with a medial cerebral artery ischemic lesion; * Confirmed motor deficit on the upper limb but not plegia (able to actively extend wrist, thumb, and at least 2 other digits \>10°), defined as a score between 0 and 2 on items 5a or 5b of the National Institute of Health Stroke Scale; * Inpatients, within no more than 4 weeks after stroke onset; * Medically stable, no intravenous medication and already able to sit for more than one hour comfortably; * Favourable opinion of the attending stroke physician; * Patient and caregiver understand the purpose of the study and provided written informed consent.
Exclusion criteria
* No detectable motor deficits at baseline assessment by the neurologist; * Severe aphasia; * Dementia (any stage); * Other cognitive or psychiatric comorbidity that impairs communication or compliance with the tasks; * Severe respiratory or cardiac condition incompatible with more than one minute of continuous mild exercise (e.g. combing hair) in a sitting position; * Pain that limits upper limb movement either on the normal or affected side; * Upper limb amputation or severe deformity either on the normal or affected side; * Fixed articular limitations of upper limb either on the normal or affected side; * Enrollment in other trial in the previous 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of correct movements | At the end of each hand-to-mouth task. | Number of correct movements performed within the duration of each hand-to-mouth task. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range of motion in degrees | At the end of each hand-to-mouth task. | Average, standard deviation and variance of the range of motion, measured in degrees, of all the correct movements performed during the duration of each hand-to-mouth task. |
| Time between correct movements in seconds | At the end of each hand-to-mouth task. | Average, standard deviation and variance of the time between correct movements, measured in seconds, of all the correct movements performed during the duration of each hand-to-mouth task. |
| Cumulative amplitude of correct movements in degrees | At the end of each hand-to-mouth task | Sum of the amplitudes of all correct movements performed within the duration of each hand-to-mouth task. |
| Cumulative amplitude of all movements performed in degrees | At the end of each hand-to-mouth task. | Sum of the amplitudes of all correct and incorrect movements performed within the duration of each hand-to-mouth task. |
| Total number of movements | At the end of each hand-to-mouth task. | Total number of correct and incorrect movements performed within the duration of each hand-to-mouth task. |
| Fatigue | At the end of each hand-to-mouth task. | Assessment of fatigue by the patient through an analogic scale from 0 (no fatigue) to 4 (interruption due to fatigue). |
| Pain | At the end of each hand-to-mouth task. | Assessment of pain by the patient through an analogic scale from 0 (no pain) to 4 (interruption due to pain). |
| Number and type of other distresses | At the end of each hand-to-mouth task. | Recording and description of any kind of discomfort reported by the patient or detected through vital parameter and arterial oxygen saturation monitoring. |
| Number of pause events during the task | At the end of each hand-to-mouth task | Number of episodes during the execution of each hand-to-mouth task where the patient stopped doing movements and/or the time between correct movements exceeded the mean plus one standard deviation measured within the same hand-to-mouth task. |
Countries
Portugal
Outcome results
None listed