Stroke Wearable Operative Rehabilitation Device Impact Trial

Study Overview
=================
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.

Official Title
-----------------
Phase II Study of the Impact of the SWORD Device on Rehabilitation Tasks Performance in the Early Post Stroke Period

Conditions
-----------------
Ischemic Stroke, Upper Extremity Hemiparesis

Intervention / Treatment
-----------------
* Device: Vibratory feedback and 3D movement analysis
* Device: Only 3D movement analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hand-to-mouth task - vibratory feedback<br>Hand-to-mouth task under vibratory feedback and 3D movement analysis. The SWORD device is in place over the patient arm, performs continuous 3D movement analysis and provides vibratory feedback according to quality performance settings established by the clinician after patient assessment. If movement is of lower amplitude or slower than prescribed a vibratory stimulus is delivered at the wrist of the patient. The intervention is repeated on the hemiparetic and normal sides and the duration of the task is defined according to the patient cardiovascular status. | Device: Vibratory feedback and 3D movement analysis<br>* Hand-to-mouth task performed under vibratory feedback combined with 3D continuous movement analysis.<br>* Other names: Stroke Wearable Operative Rehabilitation Device;|
| Active Comparator: Hand-to-mouth task - no vibratory feedback<br>Hand-to-mouth task in the same conditions as the experimental arm but without vibratory feedback, only 3D movement analysis. The SWORD device is in place over the patient arm, performs continuous 3D movement analysis but does not provides vibratory feedback according to quality performance settings established by the clinician after patient assessment. If movement is of lower amplitude or slower than prescribed NO vibratory stimulus is delivered at the wrist of the patient. The intervention is repeated on the hemiparetic and normal sides and the duration of the task is defined according to the patient cardiovascular status. | Device: Only 3D movement analysis<br>* Hand-to-mouth task performed under 3D continuous movement analysis only<br>* Other names: Stroke Wearable Operative Rehabilitation Device;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of correct movements | Number of correct movements performed within the duration of each hand-to-mouth task. | At the end of each hand-to-mouth task. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of movements | Total number of correct and incorrect movements performed within the duration of each hand-to-mouth task. | At the end of each hand-to-mouth task. | 
| Range of motion in degrees | 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. | At the end of each hand-to-mouth task. | 
| Time between correct movements in seconds | 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. | At the end of each hand-to-mouth task. | 
| Cumulative amplitude of correct movements in degrees | Sum of the amplitudes of all correct movements performed within the duration of each hand-to-mouth task. | At the end of each hand-to-mouth task | 
| Cumulative amplitude of all movements performed in degrees | Sum of the amplitudes of all correct and incorrect movements performed within the duration of each hand-to-mouth task. | At the end of each hand-to-mouth task. | 
| Number of pause events during the 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. | At the end of each hand-to-mouth task | 
| Fatigue | Assessment of fatigue by the patient through an analogic scale from 0 (no fatigue) to 4 (interruption due to fatigue). | At the end of each hand-to-mouth task. | 
| Pain | Assessment of pain by the patient through an analogic scale from 0 (no pain) to 4 (interruption due to pain). | At the end of each hand-to-mouth task. | 
| Number and type of other distresses | Recording and description of any kind of discomfort reported by the patient or detected through vital parameter and arterial oxygen saturation monitoring. | At the end of each hand-to-mouth task. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, motor deficits, motor rehabilitation, neurorehabilitation, medical devices, wearable devices, e-health systems