Clinical trial NCT06441552: The Natural History of Recovery After Stroke
Official title: Learning the Natural History of Recovery After Stroke - Cognitive, Motor and Sensory Function
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Vascular Accident (CVA)/Stroke
Lead sponsor: Adi Negev-Nahalat Eran
Sponsor class: OTHER
Collaborators: name: Ben-Gurion University of the Negev
name: Technion, Israel Institute of Technology
First posted: 2024-06-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke survivors and healthy adults.

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.

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.

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.

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Action Research Arm Test (ARAT)
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: 10-meter walk test (10MWT)
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Secondary outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: Baseline (<3weeks)
measure: The Stroke Self-Efficacy Questionnaire (SSEQ)
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: The Nine Hole Peg Test (NHPT)
timeFrame: Baseline (<3weeks), 1-year
measure: The Functional Dexterity Test (FDT)
timeFrame: Baseline (<3weeks), 1-year
measure: The Behavioral Inattention Test (BIT)
timeFrame: Baseline (<3weeks)
measure: The Ashworth scale
timeFrame: Baseline (<3weeks)
measure: Kinetics-fingers1
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Kinetics-fingers2
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Kinetics-grip
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Kinematics-reaching
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Kinematics-duration
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Kinematics-smoothness
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Kinematics-Inter-joint coordination
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Rehabilitation-intensity
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Rehabilitation-time
timeFrame: one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Rehabilitation-period
timeFrame: one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Supporting data-age
timeFrame: Baseline
measure: Supporting data-sex
timeFrame: Baseline
measure: Supporting data-time1
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Supporting data-time2
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: anthropometric data-height
timeFrame: Baseline
measure: anthropometric data-weight
timeFrame: Baseline
measure: supporting data-directional
timeFrame: Baseline
measure: supporting data-medical history
timeFrame: Baseline
measure: Cognition-impairment
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Cognition-inhibition1
timeFrame: one or more of : Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Cognition-inhibition2
timeFrame: one or more of : Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Timed up and Go test (TUG)
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Gait Specific attentional profile (G-SAP)
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Gait analysis-temporal
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Gait analysis-spatial
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Gait analysis-steadiness
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Gaze-angle1
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Gaze-angle2
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Gaze-downward
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Gaze-look-ahead distance
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Balance-Berg
timeFrame: baseline
measure: Balance-postural steadiness1
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Balance-postural steadiness2
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Balance-postural steadiness3
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Balance-postural steadiness4
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Habitual activity1
timeFrame: one or more of :Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Habitual activity2
timeFrame: one or more of :Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Sensory-tactile
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Coordination-LE1
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Coordination-LE2
timeFrame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Reticulospinal excitability
timeFrame: one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Muscle controllability1
timeFrame: one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Muscle controllability2
timeFrame: one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Muscle controllability3
timeFrame: one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
measure: Neuroimaging
timeFrame: one or more of :1-month, 3-month, 6-month, 1-year
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam/Technion
city: Ofakim
country: Israel
facility: Adi-Negev Nahalat Eran
city: Hebron
country: Palestinian Territory, occupied
facility: Al-Ahli hospital
Study officials:
affiliation: Ben-Gurion University of the Negev
name: Simona Bar-Haim, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ben-Gurion University of the Negev
name: Lior Smuelof, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ben-Gurion University of the Negev
name: Shirley Handelzalts, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Technion, Israel Institute of Technology
name: Firas Mawase, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Green Land Society for Health Development
name: Akram Amro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.