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

Efficacy of High-dosage, High-intensity Rehabilitation Program on the Motor Recovery After Stroke in Subacute Patients

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).

Study Overview

• Status: Recruiting
• Conditions: Stroke; Hemiplegia and Hemiparesis
• Intervention / Treatment: Behavioral: High dosage, high intensity motor rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gil Meir; Phone Number: +972 0548340307; Email: gilmeir10@gmail.com

Study Locations

• Israel
  • Ofakim, Israel
    • Not yet recruiting
    • Adi Negev-Nahalat Eran
    • Contact: Lior Shmuelof, Prof.; Phone Number: +972 0547510795; Email: shmuelof@bgu.ac.il
    • Principal Investigator: Lior Shmuelof, Prof.
    • Sub-Investigator: Gil Meir
  • Ofakim, Israel
    • Recruiting
    • Adi Negev-Nahalat Eran
    • Contact: Gil Meir; Phone Number: +9720548340307; Email: gilmeir10@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: This group will be provided with additional rehab time during the sub actue phase.; Participants will receive additional technology-based upper extremity training for 120 min/day, 5d/w, 4 weeks. The program will be tailored to their impairment level, and will be added to the usual treatment given during hospitalization.	Behavioral: High dosage, high intensity motor rehabilitation; Participants will receive additional technology-based upper extremity training for 120 min/day, 5d/w, 4 weeks.
No Intervention: Matched group from an ongoing project with identical criteria.; This group is comprised of patients with similar characteristics and the intervention group will be compared to this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Enrollment, 1 month, 3 months, 6 months after enrollment
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.	Enrollment, 1 month, 3 months, 6 months after enrollment
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.	Enrollment, 1 month, 3 months, 6 months after enrollment
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.	Enrollment, 1 month, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Enrollment and 3 months.
Time on task	Actual time spent training during a practice session.	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.
Attendance	The rate in which a participant actively participated in the training sessions.	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.
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.	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.
Rating of perceived exertion (RPE)	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 measure will be recorded every single practice session, twice a day, 5 days a week.
The Intrinsic Motivation Inventory (IMI)	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.	At the end of the intervention period for each participant (i.e. 4 weeks).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Only at enrollment.
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.	At the end of the intervention period (i.e. 4 weeks)

Collaborators and Investigators

• Sponsor: Adi Negev-Nahalat Eran
• Collaborators: Ben-Gurion University of the Negev
• Investigators: Principal Investigator: Lior Shmuelof, Prof., Ben-Gurion University of the Negev

Publications and helpful links

General Publications

• Miller EL, Murray L, Richards L, Zorowitz RD, Bakas T, Clark P, Billinger SA; American Heart Association Council on Cardiovascular Nursing and the Stroke Council. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010 Oct;41(10):2402-48. doi: 10.1161/STR.0b013e3181e7512b. Epub 2010 Sep 2. No abstract available.
• Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7.
• Biernaskie J, Chernenko G, Corbett D. Efficacy of rehabilitative experience declines with time after focal ischemic brain injury. J Neurosci. 2004 Feb 4;24(5):1245-54. doi: 10.1523/JNEUROSCI.3834-03.2004.
• Buch ER, Rizk S, Nicolo P, Cohen LG, Schnider A, Guggisberg AG. Predicting motor improvement after stroke with clinical assessment and diffusion tensor imaging. Neurology. 2016 May 17;86(20):1924-5. doi: 10.1212/WNL.0000000000002675. Epub 2016 Apr 29. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): July 15, 2027

Study Registration Dates

• First Submitted: June 10, 2025
• First Submitted That Met QC Criteria: June 28, 2025
• First Posted (Actual): July 9, 2025

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Stroke Rehabilitation; Motor Impairment; Post-stroke High Dosage Rehab; Technological Rehab Post Stroke; Stroke Kinematics
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Stroke; Paresis; Hemiplegia
• Other Study ID Numbers: NGV-24-0006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data to be shared will include de-identified information collected during the trial, such as demographic and baseline characteristics, intervention allocations, and all outcome measures used in both the primary and secondary analyses. In addition, supporting documentation will be provided to facilitate proper use of the data, including the study protocol, statistical analysis plan, informed consent form template, and a comprehensive data dictionary.
• IPD Sharing Time Frame: The de-identified individual participant data and supporting documentation will be made available beginning six months after publication of the primary results and will remain accessible for a minimum of five years thereafter.
• IPD Sharing Access Criteria: Qualified researchers with a scientifically sound proposal will be able to request access to the de-identified individual participant data and supporting documents, including the study protocol, statistical analysis plan, informed consent form template, and data dictionary. Access will be granted through a secure data repository following submission and approval of a data access request. Researchers will be required to sign a data use agreement outlining conditions for responsible data use, including maintaining confidentiality and using the data only for the approved purpose. Access will be provided through controlled mechanisms, such as registered user accounts or institutional credentials, depending on the repository's access procedures.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No