The Efficacy of Additional Motor Training Dosage During the Early Stages Post Stroke on the Upper Extremity Recovery

Not Applicable

Recruiting

• Conditions: Stroke; Hemiplegia and Hemiparesis

• Registration Number: NCT07056049
• Lead Sponsor: Adi Negev-Nahalat Eran

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-28
• Status Verified: 2025-07
• Study First Posted: 2025-07-09
• Study Start: 2025-07-13
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-17
• Primary Completion: 2027-01-15
• Study Completion: 2027-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer upper extremity assessment (FM-UE)	Enrollment, 1 month, 3 months, 6 months after enrollment	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)	Enrollment, 1 month, 3 months, 6 months after enrollment	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	Enrollment, 1 month, 3 months, 6 months after enrollment	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	Enrollment, 1 month, 3 months, 6 months	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 Outcome Measures

Name	Time	Method
Upper extremity activity	Enrollment and 3 months.	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	The measure will be recorded every single practice session, twice a day, 5 days a week. Total Time on Task will be calculated at the end of the intervention period, approximately 4 weeks.	Actual time spent training during a practice session.
Attendance	The measure will be recorded every single practice session, twice a day, 5 days a week. Total attendance will be calculated at the end of the intervention period, approximately after 4 weeks.	The rate in which a participant actively participated in the training sessions.
Visual Analogue Scale for pain	The measure will be recorded before and after every single practice session, twice a day, 5 days a week. The mean pain level delta will be calculated at the end of the intervention period, approximately 4 weeks.	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.
Rating of perceived exertion (RPE)	The measure will be recorded every single practice session, twice a day, 5 days a week.	The revised category-ratio scale (0 to 10 scale) will be used to monitor and guide exercise intensity. Participants subjectively rate their level of exertion during exercise (American College of Sports Medicine, 2010). A higher score means higher exertion experienced by the participant during the session.; It is not necessarily good or bad, it is just an indication of the effort.
The Intrinsic Motivation Inventory (IMI)	At the end of the intervention period for each participant (i.e. 4 weeks).	The IMI is a validated self-report tool used to assess intrinsic motivation toward a specific activity. It includes multiple subscales, with Interest/Enjoyment considered the primary indicator of intrinsic motivation. Items are rated on a 7-point Likert scale (1 = not at all true, 7 = very true), and subscale scores are averaged to produce interpretable values. Higher scores reflect greater intrinsic motivation, perceived competence, or effort, depending on the subscale.

Trial Locations

Locations (1)

Adi Negev-Nahalat Eran; 🇮🇱 Ofakim, Israel