About this trial
Intervention abstract
Background: Stroke is the leading cause of long-term disability, and the second leading cause of death in the western world. Most stroke survivors will suffer from motor and cognitive disturbances for the rest of their life, which negatively affects their normal daily life.
Despite the decline in stroke-related mortality over the past decades, the outcome of rehabilitation programs does not improve, and is predictable regardless of the program used. Still, several human and animal studies show that high capacity of training in the early stages post stroke improve motor recovery. This notion is far from being well established.
Aim: Studying the effect of high-dosage, high-intensity training program in the subacute period on upper extremity motor recovery.
Population: Stroke survivors. Study duration: 6 months. Study protocol: Participants will receive additional technology-based upper extremity training for 120 min/day, 5d/w, 4 weeks. They will be monitored pre and post training, and 6 months post-stroke. Outcome measures will include clinical, kinematic and adherence measures (see complete list in the protocol).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
High dosage, high intensity motor rehabilitation
BehavioralParticipants will receive additional technology-based upper extremity training for 120 min/day, 5d/w, 4 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Fugl-Meyer upper extremity assessment (FM-UE)
The Upper Extremity Fugl-Meyer Assessment (UE-FMA) is a standardized clinical tool designed to evaluate motor impairment in the upper limb following a stroke. It is part of the broader Fugl-Meyer Assessment, one of the most widely used and validated scales in stroke rehabilitation research. The UE-FMA specifically assesses movement, coordination, and reflexes in the shoulder, elbow, forearm, wrist, and hand, with a maximum score of 66 points. The scale is divided into subcomponents, including upper limb movement (36 points), wrist (10 points), hand (14 points), and coordination/speed (6 points). Each item is scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), offering a total score that reflects the level of motor impairment-higher scores indicate better motor function. The UE-FMA is valued for its reliability, sensitivity to impairment (rather than function), and its ability to track motor recovery over time.
Action research arm test (ARAT)
The Action Research Arm Test (ARAT) is a standardized clinical tool used to assess upper limb function following stroke or neurological injury, with a focus on evaluating the ability to perform purposeful, goal-directed tasks. It consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement, each designed to measure different aspects of upper limb activity. Tasks include actions such as picking up small blocks, pouring water, or moving objects across a table. Each item is scored on a 4-point ordinal scale ranging from 0 (no movement) to 3 (normal performance), yielding a maximum total score of 57. The ARAT captures the functional use of the hand and arm in a way that reflects real-world tasks, making it especially relevant for tracking meaningful improvements during rehabilitation. It is known for its high inter-rater and intra-rater reliability and is sensitive to changes in functional performance across a wide spectrum of impairment levels.
Stroke Impact Scale (SIS) hand domain, version 2.0
The Stroke Impact Scale (SIS) hand domain, version 2.0, is a patient-reported outcome measure that assesses the perceived difficulty of using the affected hand in everyday tasks following a stroke. This domain includes five items that ask individuals to rate the difficulty of performing common activities such as carrying heavy objects, turning a doorknob, or picking up a coin. Each item is scored on a 5-point Likert scale ranging from 1 (could not do it at all) to 5 (not difficult at all), reflecting the patient's experience over the past week. Scores are converted to a 0-100 scale, with higher scores indicating better perceived hand function. The SIS hand domain captures the individual's perspective on the functional impact of stroke on daily activities, providing valuable insight into real-world hand use. It is frequently used in stroke rehabilitation studies to complement performance-based assessments and to evaluate patient-centered outcomes.
Kinematics
Using reaching tasks that will be recorded using multiple high resolution video-cameras and analyzed using AI algorithm (OpenPose). Outcome measures that will be examined include: trajectory smoothness, reaching extent, shoulder-elbow synergy, movement time and deviation from trajectories of age matched healthy controls.
Secondary outcomes
Upper extremity activity
Daily natural activity will be monitored for using IMUs (Movella DOT) worn on upper extremity and trunk for periods of up-to 6 hours.
Time on task
Actual time spent training during a practice session.
Attendance
The rate in which a participant actively participated in the training sessions.
Visual Analogue Scale for pain
The VAS is a self-report measure consisting of a 10 centimeter line with a statement at each end representing one extreme of pain intensity (No pain and pain as bad as it could possibly be). The participant gives their indication with a pen mark on the line corresponding to their present pain level. The higher the score, the worse the pain.
Other outcomes
Berg Balance Scale (BBS)
Consists of 14 items for assessing static and dynamic balance and risk of falls for different populations. The test includes different tasks in various challenging positions and scored up to 56 points. A higher score indicated better balance and lower risk of falls.
Fatigue Severity Scale (FSS)
The 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. A higher scale indicated higher fatigue level.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Adi Negev-Nahalat Eran
Lead sponsor
Ben-Gurion University of the Negev
Collaborator