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

NCT07056049 | Recruiting

• 1 other identifier: NGV-24-0006
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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).

Conditions

Stroke; Hemiplegia and Hemiparesis

Keywords

Stroke Rehabilitation; Motor Impairment; Post-stroke High Dosage Rehab; Technological Rehab Post Stroke; Stroke Kinematics

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Upper extremity activity

  Enrollment and 3 months.

• 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.

• 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.

• 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.

• Rating of perceived exertion (RPE)

  The measure will be recorded every single practice session, twice a day, 5 days a week.

Other Outcomes (2)

• Berg Balance Scale (BBS)

  Only at enrollment.

• Fatigue Severity Scale (FSS)

  At the end of the intervention period (i.e. 4 weeks)

Study Arms (2)

This group will be provided with additional rehab time during the sub actue phase.

EXPERIMENTAL

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

Matched group from an ongoing project with identical criteria.

NO INTERVENTION

This group is comprised of patients with similar characteristics and the intervention group will be compared to this group.

Interventions

High dosage, high intensity motor rehabilitation BEHAVIORAL

Participants will receive additional technology-based upper extremity training for 120 min/day, 5d/w, 4 weeks.

This group will be provided with additional rehab time during the sub actue phase.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adi Negev-Nahalat Eran: lead
• Ben-Gurion University of the Negev: collaborator

Study Sites (2)

Adi Negev-Nahalat Eran

Ofakim, Israel

NOT YET RECRUITING

Adi Negev-Nahalat Eran

Ofakim, Israel

RECRUITING

Related Publications (4)

• 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.

  PMID: 20813995 BACKGROUND

• 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.

  PMID: 12907818 BACKGROUND

• 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.

  PMID: 27164664 BACKGROUND

• 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.

  PMID: 14762143 BACKGROUND

MeSH Terms

Conditions

Stroke; Hemiplegia; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lior Shmuelof, Prof.

  Ben-Gurion University of the Negev

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gil Meir

CONTACT

+972 0548340307; gilmeir10@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention group will be compared to a matched historical cohort, that will be added to in parallel during recruitment.

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: July 9, 2025
• Study Start: July 13, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

IL (2)