The Natural History of Recovery After Stroke

NCT ID: NCT06441552

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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This study constitutes the first step in the RESTRO project: Evaluation of an accessible and affordable neurorehabilitation program to promote recovery and to enhance the quality of life after stroke. In this study, we will monitor sensorimotor and cognitive functions of Stroke patients along the first 6 to 12 month following their stroke. Data from three primary sites will be collected and compared in several time points, and its relation to the type and intensity of the rehabilitation program, usually provided in each site, will be tested.

Conditions

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Cerebral Vascular Accident (CVA)/Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ofakim

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

non-interventional

Intervention Type OTHER

non-interventional

Haifa

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

non-interventional

Intervention Type OTHER

non-interventional

Hebron

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

non-interventional

Intervention Type OTHER

non-interventional

Interventions

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non-interventional

non-interventional

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \>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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ben-Gurion University of the Negev

OTHER

Sponsor Role collaborator

Technion, Israel Institute of Technology

OTHER

Sponsor Role collaborator

Adi Negev-Nahalat Eran

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simona Bar-Haim, PhD

Role: PRINCIPAL_INVESTIGATOR

Ben-Gurion University of the Negev

Lior Smuelof, PhD

Role: PRINCIPAL_INVESTIGATOR

Ben-Gurion University of the Negev

Shirley Handelzalts, PhD

Role: PRINCIPAL_INVESTIGATOR

Ben-Gurion University of the Negev

Firas Mawase, PhD

Role: PRINCIPAL_INVESTIGATOR

Technion, Israel Institute of Technology

Akram Amro, PhD

Role: PRINCIPAL_INVESTIGATOR

Green Land Society for Health Development

Locations

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Rambam/Technion

Haifa, , Israel

Site Status NOT_YET_RECRUITING

Adi-Negev Nahalat Eran

Ofakim, , Israel

Site Status RECRUITING

Al-Ahli hospital

Hebron, , Palestinian Territories

Site Status NOT_YET_RECRUITING

Countries

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Israel Palestinian Territories

Central Contacts

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Simona Bar-Haim, PhD

Role: CONTACT

972-54-470-2553

Lior Smuelof, PhD

Role: CONTACT

Facility Contacts

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David Tanne, MD

Role: primary

Firas Mawase, PhD

Role: backup

972-54-782-3017

Shilo Kramer, MD

Role: primary

Simona Bar-Haim, PhD

Role: backup

Akram Amro, PhD

Role: primary

References

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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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 7845561 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26651329 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8224055 (View on PubMed)

Other Identifiers

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SIS70023GR0026

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ADINEGEV-2023_106

Identifier Type: -

Identifier Source: org_study_id

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