Intensive Upper Extremity Training Program During the Early Subacute Phase After Stroke: A Feasibility Study
Intensive Upper Extremity Training Program During the Early Subacute Phase After Stroke: A Feasibility Study
The study assesses the feasibility of a 4-week upper extremity training program emphasizing
 quality of movement practiced at high intensity and dosage applied during the early subacute
 phase after stroke.
Participants will receive 120 minutes of upper extremity training X 5 days per week for 4
 weeks in addition to their daily rehabilitative routine (total therapy time 40 hours in
 addition to daily routine treatments of approximately 60 hours). Each session will be staffed
 with a 1:1 PT/OT to patient ratio.

 The aim of the program is to increase the time spent on tasks using customized game-based
 platforms that include highly immersive, challenging and rewarding virtual environments for
 upper limb training. The focus of these game-based platforms is to reduce upper extremity
 impairments through emphasizing the quality of movement execution.

 In one platform, the participant controls virtual dolphin movements by moving his/her paretic
 upper limb. The game utilizes advanced artificial intelligence (AI) analysis of the video
 recordings in real-time. In case the participant needs arm weight support, the practice will
 perform the task with a mechanical wearable exoskeleton vest, EkssoUE (Ekso Bionics) that can
 provide support at different weight levels. Arm weight support will be titrated as the
 patient progresses through each session and will be reduced/removed if no significant
 compensatory strategies were used.

 The second platform, the HandTutor system (MediTouch) consists of an ergonomic wearable glove
 and a dedicated software with games that allow practicing active wrist movements, grip
 control and finger individuation in a challenging and motivating environment. Participant
 progresses through simple to difficult games while adjusting the range of motion that is
 being practiced according to participant's abilities.

 Training in both platforms will be conducted in sitting. Participant will continue with their
 regular rehabilitative routine that includes daily physical and occupational therapy sessions
 and speech therapy if needed as well as group work and gym.

 To assess the feasibility of the proposed intervention the following data/measures will be
 documented:

 Adherence rates; Time on task (in minutes); Progression in game levels and the amount of
 weight support; Attendance to routine rehabilitative sessions; Visual Analogue Scale will be
 used to monitor the levels of pain; Rating perceived exertion (RPE), the revised
 category-ratio scale (0 to 10 scale) will be used to monitor and guide exercise intensity;
 The Pittsburgh rehabilitation participation scale (PRPS); The Intrinsic Motivation Inventory
 (IMI) - will be assessed at the end of intervention period; Acceptability and satisfaction of
 the intervention to participants will be assessed at the end of training period using a
 self-designed questionnaire/rating scale; Adverse events; Problems/difficulties related to
 intervention equipment (software, hardware, vest etc.).

 To evaluate the potential effectiveness of the intervention the following data/measures will
 be conducted at baseline (prior training), immediately post intervention and at 12 (±14) and
 24 (±14) weeks post stroke:

 Fugl-Meyer upper extremity assessment (FM-UE); Action research arm test (ARAT); Stroke Impact
 Scale (SIS) hand domain, version 2.0; Upper extremity impairment and function will be
 assessed using a reaching and a grasping tasks that will be recorded using multiple high
 resolution video-cameras and analyzed using AI algorithm (OpenPose).
Inclusion criteria:

 -  age ≥18 years;

 -  Ischemic or hemorrhagic stroke (hemispheric or brainstem) confirmed by CT or MRI;

 -  First-ever stroke or previous stroke with no upper extremity weakness;

 -  1 week ≤ Time after stroke onset ≤ 6 weeks;

 -  Active shoulder flexion of at least 20◦ and partial wrist and/or finger active
 movement;

 -  Ability to provide inform consent.

 Exclusion criteria:

 -  A painful shoulder limiting an active forward reach;

 -  Severe spasticity or non-neural loss of range of motion;

 -  Cognitive or communication impairments as determined by the clinical team;

 -  Unstable medical conditions.