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Recruiting NCT06441552

The Natural History of Recovery After Stroke

— Observational Cerebral Vascular Accident (CVA)/Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: non-interventional.
Who it may be relevant to
Registry conditions: Cerebral Vascular Accident (CVA)/Stroke. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel, Palestinian Territories
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Learning the Natural History of Recovery After Stroke - Cognitive, Motor and Sensory Function

Overview

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

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.

Interventions

  • Other non-interventional
    non-interventional

Primary outcome measures

  • Fugl-Meyer Assessment (FMA) [Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year]
  • Action Research Arm Test (ARAT) [Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year]
  • 10-meter walk test (10MWT) [Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year]
Secondary outcome measures (12)
  • National Institutes of Health Stroke Scale (NIHSS) [Time frame: Baseline (<3weeks)]
  • The Stroke Self-Efficacy Questionnaire (SSEQ) [Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year]
  • The Nine Hole Peg Test (NHPT) [Time frame: Baseline (<3weeks), 1-year]
  • The Functional Dexterity Test (FDT) [Time frame: Baseline (<3weeks), 1-year]
  • The Behavioral Inattention Test (BIT) [Time frame: Baseline (<3weeks)]
  • The Ashworth scale [Time frame: Baseline (<3weeks)]
  • Kinetics-fingers1 [Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year]
  • Kinetics-fingers2 [Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year]
  • Kinetics-grip [Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year]
  • Kinematics-reaching [Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year]
  • Kinematics-duration [Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year]
  • Kinematics-smoothness [Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Israel · 2 centers
  • Rambam/Technion — Haifa
  • Adi-Negev Nahalat Eran — Ofakim
Palestinian Territories · 1 center
  • Al-Ahli hospital — Hebron

Publications

  • 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.
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06441552 · ADINEGEV-2023_106 · SIS70023GR0026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗