The Natural History of Recovery After Stroke

NCT06441552 | Recruiting

• 2 other identifiers: ADINEGEV-2023_106SIS70023GR0026
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 3

Brief Summary

The goal of this longitudinal observational study is to learn the course of recovery after stroke. Specifically, in this study we will learn and describe the changes in cognitive, motor and sensory function over time in stroke patients.

Conditions

Cerebral Vascular Accident (CVA)/Stroke

Outcome Measures

Primary Outcomes (3)

• Fugl-Meyer Assessment (FMA)

  Fugl-Meyer Assessment: Motor score is on a 0-100 scale. High score is better.

  Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

• Action Research Arm Test (ARAT)

  Action Research Arm Test Score is on a 0-57 scale. High score is better.

  Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

• 10-meter walk test (10MWT)

  Outcome is the average walking velocity over 10 meters. Measured in m/sec.

  Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

Secondary Outcomes (51)

• National Institutes of Health Stroke Scale (NIHSS)

  Baseline (<3weeks)

• The Stroke Self-Efficacy Questionnaire (SSEQ)

  Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

• The Nine Hole Peg Test (NHPT)

  Baseline (<3weeks), 1-year

• The Functional Dexterity Test (FDT)

  Baseline (<3weeks), 1-year

• The Behavioral Inattention Test (BIT)

  Baseline (<3weeks)

Study Arms (3)

Ofakim

Non-interventional group, recruited at Adi-Negev Rehabilitation Center, Israel.

Other: non-interventional

Haifa

Non-interventional group, recruited at Rambam Health Care Campus, Israel.

Other: non-interventional

Hebron

Non-interventional group, recruited through Green Land Society for Health Development, Palestine.

Other: non-interventional

Interventions

non-interventional OTHER

non-interventional

Haifa; Hebron; Ofakim

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stroke survivors and healthy adults.

You may qualify if:

• \>18 years of age
• Independent in all activities of daily living before the stroke.
• In- and out-patients at Adi-Negev Nahalat-Eran rehabilitation center, with first ever stroke, or with a recurrent stroke that did not lead to disability (were independent in ADL before the second stroke).
• Medically stable
• Able to provide informed consent.

You may not qualify if:

• The presence of any degenerative neurological condition, neuropathy, myopathy or Polio that are not secondary to stroke, excluding diabetic related changes.
• Traumatic brain injury and/or extra-cerebral hemorrhage.
• Significant psychiatric condition, including alcoholism and drug abuse.
• Any severe orthopedic condition (such as amputation or severe pain that limits activity) or chronic pain syndrome.
• Participation in another interventional study.

Sponsors & Collaborators

• Adi Negev-Nahalat Eran: lead
• Ben-Gurion University of the Negev: collaborator
• Technion, Israel Institute of Technology: collaborator

Study Sites (3)

Rambam/Technion

Haifa, Israel

NOT YET RECRUITING

Adi-Negev Nahalat Eran

Ofakim, Israel

RECRUITING

Al-Ahli hospital

Hebron, Palestinian Territories

NOT YET RECRUITING

Related Publications (4)

• Rosenstein, M. T., Collins, J. J., & De Luca, C. J. (1993). A practical method for calculating largest Lyapunov exponents from small data sets. Physica D: Nonlinear Phenomena, 65(1-2), 117-134.

  BACKGROUND

• Platz T, Denzler P, Kaden B, Mauritz KH. Motor learning after recovery from hemiparesis. Neuropsychologia. 1994 Oct;32(10):1209-23. doi: 10.1016/0028-3932(94)90103-1.

  PMID: 7845561 BACKGROUND

• Balasubramanian S, Melendez-Calderon A, Roby-Brami A, Burdet E. On the analysis of movement smoothness. J Neuroeng Rehabil. 2015 Dec 9;12:112. doi: 10.1186/s12984-015-0090-9.

  PMID: 26651329 BACKGROUND

• Collins JJ, De Luca CJ. Open-loop and closed-loop control of posture: a random-walk analysis of center-of-pressure trajectories. Exp Brain Res. 1993;95(2):308-18. doi: 10.1007/BF00229788.

  PMID: 8224055 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Simona Bar-Haim, PhD

  Ben-Gurion University of the Negev

  PRINCIPAL INVESTIGATOR

• Lior Smuelof, PhD

  Ben-Gurion University of the Negev

  PRINCIPAL INVESTIGATOR

• Shirley Handelzalts, PhD

  Ben-Gurion University of the Negev

  PRINCIPAL INVESTIGATOR

• Firas Mawase, PhD

  Technion, Israel Institute of Technology

  PRINCIPAL INVESTIGATOR

• Akram Amro, PhD

  Green Land Society for Health Development

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simona Bar-Haim, PhD

CONTACT

972-54-470-2553; barhaims@bgu.ac.il

Lior Smuelof, PhD

CONTACT

shmuelof@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: June 4, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

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

Locations

IL (2); PA (1)