The Natural History of Recovery After Stroke (RESTRO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Vascular Accident (CVA)/Stroke
• Intervention / Treatment: Other: non-interventional

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Simona Bar-Haim, PhD; Phone Number: 972-54-470-2553; Email: barhaims@bgu.ac.il
• Study Contact Backup: Name: Lior Smuelof, PhD; Email: shmuelof@gmail.com

Study Locations

• Israel
  • Haifa, Israel
    • Not yet recruiting
    • Rambam/Technion
    • Contact: David Tanne, MD; Email: D_TANNE@rambam.health.gov.il
    • Contact: Firas Mawase, PhD; Phone Number: 972-54-782-3017; Email: mawasef@bm.technion.ac.il
    • Principal Investigator: Firas Mawase, PhD
  • Ofakim, Israel
    • Recruiting
    • Adi-Negev Nahalat Eran
    • Contact: Shilo Kramer, MD; Email: shilok@adi-il.org
    • Contact: Simona Bar-Haim, PhD; Email: barhaims@bgu.ac.il
    • Principal Investigator: Lior Smuelof, PhD
• Palestinian Territories
  • Hebron, Palestinian Territories
    • Not yet recruiting
    • Al-Ahli hospital
    • Contact: Akram Amro, PhD; Email: akram1973@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Stroke survivors and healthy adults.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ofakim; Non-interventional group, recruited at Adi-Negev Rehabilitation Center, Israel.	Other: non-interventional; non-interventional
Haifa; Non-interventional group, recruited at Rambam Health Care Campus, Israel.	Other: non-interventional; non-interventional
Hebron; Non-interventional group, recruited through Green Land Society for Health Development, Palestine.	Other: non-interventional; non-interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Institutes of Health Stroke Scale (NIHSS)	measure of stroke severity on a 0-42 scale, with lower scores indicates lower severity (lower is better).	Baseline (<3weeks)
The Stroke Self-Efficacy Questionnaire (SSEQ)	This is a self-reported ability perception scale. Outcome range is 0-130 with higher scores indicate a better self-perceived ability.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
The Nine Hole Peg Test (NHPT)	This is an upper extremity dexterity test. Outcome is the time taken to complete the task. Measured in sec.	Baseline (<3weeks), 1-year
The Functional Dexterity Test (FDT)	This is an upper extremity dexterity test. Outcome is the time taken to complete the task. Measured in sec.	Baseline (<3weeks), 1-year
The Behavioral Inattention Test (BIT)	This is an instrument aimed at detecting visual neglect. In this study we use only two subsections of the test: star cancellation (scored on a 0-54 scale) and representational drawing (scored on a 0-3 scale). For both, higher scores are better.	Baseline (<3weeks)
The Ashworth scale	This instrument is used to detect spasticity (increased muscle tone). Outcome is 0-4 scale, with lower scores means better outcome (less spasticity).	Baseline (<3weeks)
Kinetics-fingers1	To measure fingers kinetics, we will use a custom-built device that measures finger force for flexion and extension. Outcome is the force in Newtons (N) generated by each finger.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Kinetics-fingers2	To measure fingers kinetics, we will use a custom-built device that measures finger force for flexion and extension. Outcome measure is the Individuation Index, measured in arbitrary units (a.u.). The individuation index is calculated as the ratio between the forces generated by the non-instructed digits and the force generated by the instructed digit. This index evaluates the ability to generate force in each digit independently of the other digits.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Kinetics-grip	Grip force will be measured using the microFET Digital HandGrip Dynamometer (Hoggan Scientific). Outcome is the maximal force in Newtons.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Kinematics-reaching	Kinematic measurements of upper extremity reaching task: Kinematic measures will be extracted using markerless pose estimation algorithms (such as OpenPose and MediaPipe). Reaching error (distance of the hand from the target) and reaching extent (maximum distance of the wriest from the shoulder). Measured in mm.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Kinematics-duration	Kinematic measurements of upper extremity reaching tasks: Kinematic measures will be extracted using markerless pose estimation algorithms (such as OpenPose and MediaPipe). Reaching duration. Measured in seconds.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Kinematics-smoothness	Kinematic measurements of upper extremity reaching tasks: Kinematic measures will be extracted using markerless pose estimation algorithms (such as OpenPose and MediaPipe). Reaching smoothness as the integrated jerk (as described by Platz et al. 1994, Dimensions are L^2/T^6) and the spectral arch length (as described by Balasubramanian et al. 2015).	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Kinematics-Inter-joint coordination	Kinematic measurements of upper extremity reaching tasks: Kinematic measures will be extracted using markerless pose estimation algorithms (such as OpenPose and MediaPipe). Inter-joint coordination will be measured through computing the cross correlation between elbow, writs and shoulder joint angles and the proportion of time when joints flexed or extend together. Arbitrary units.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Rehabilitation-intensity	Number of rehabilitative sessions per week, in total and for each modality separately (e.g., physical therapy, occupational therapy, etc.)	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Rehabilitation-time	Time, in minutes, of each therapy session.	one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Rehabilitation-period	Period of time (in month) for which the participant received therapy.	one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Supporting data-age	Age at admission, in years.	Baseline
Supporting data-sex	Biological Male or Female	Baseline
Supporting data-time1	time from stroke onset in days	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Supporting data-time2	other time periods (e.g., inpatient time, rehabilitation duration, etc.) in Months.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
anthropometric data-height	Height in cm	Baseline
anthropometric data-weight	Weight in kg	Baseline
supporting data-directional	affected brain side: L/R/Both affected body side: L/R/Both hand dominance: L/R leg dominance: L/R	Baseline
supporting data-medical history	Any relevant history of illnesses.	Baseline
Cognition-impairment	Montreal Cognitive Assessment (MoCA). 0-30 scale with higher values indicate better cognitive state.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Cognition-inhibition1	Percent correct responses in an anti-saccade computerized task.	one or more of : Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Cognition-inhibition2	Reaction time (in msec) in an anti-saccade computerized task.	one or more of : Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Timed up and Go test (TUG)	Time taken to complete the TUG task. Measured in seconds.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Gait Specific attentional profile (G-SAP)	This is a questioner aimed at evaluating the attentional profile of the patient during walking. It has several subscales measured on a Likert 5-point scale. Total score range is 11-55 with lower values indicate better outcome.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Gait analysis-temporal	Gait analysis while participants are walking on a treadmill (Zebris FDM-T Treadmill, Zebris Medical GmbH, Germany) with an embedded force sensors array. Temporal measures include step and stride time. Measured in seconds.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Gait analysis-spatial	Gait analysis while participants are walking on a treadmill (Zebris FDM-T Treadmill, Zebris Medical GmbH, Germany) with an embedded force sensors array. Spatial measures include step and stride length and width. Measured in meters.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Gait analysis-steadiness	Gait analysis while participants are walking on a treadmill (Zebris FDM-T Treadmill, Zebris Medical GmbH, Germany) with an embedded force sensors array. Steadiness is measured by calculating the maximal Lyapunov exponent of the center of pressure dynamics (as described by Rosenstein et al. 1993). Units of measure are arbitrary.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Gaze-angle1	Gaze behavior during walking using a mobile eye-tracker (Pupil Invisible, Pupil Labs, Germany). Head, eye and gaze (head and eye combined) angles on the sagittal and horizontal planes will be measured. Outcome in degrees.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Gaze-angle2	Gaze behavior during walking using a mobile eye-tracker (Pupil Invisible, Pupil Labs, Germany). Gaze angles will be measured relative to the vanishing point. Outcome in %.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Gaze-downward	Gaze behavior during walking using a mobile eye-tracker (Pupil Invisible, Pupil Labs, Germany). Time spent looking onto the walking surface. Outcome in %.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Gaze-look-ahead distance	Gaze behavior during walking using a mobile eye-tracker (Pupil Invisible, Pupil Labs, Germany). Look-ahead distance. Outcome in meters.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Balance-Berg	Berg Balance Scale (BBS) measured on a 0-56 scale with higher score represent better outcome.	baseline
Balance-postural steadiness1	Postural Sway (Zebris FDM-T Treadmill, Zebris Medical GmbH, Germany). Outcome is sway range in mm.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Balance-postural steadiness2	Postural Sway (Zebris FDM-T Treadmill, Zebris Medical GmbH, Germany). Outcome is sway velocity in mm/sec.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Balance-postural steadiness3	Postural Sway (Zebris FDM-T Treadmill, Zebris Medical GmbH, Germany). Outcome is sway area in mm^2.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Balance-postural steadiness4	Postural Sway (Zebris FDM-T Treadmill, Zebris Medical GmbH, Germany). Outcome is the short-term diffusion coefficients, as described by Collins and De-Luka (1993), measured in mm^2/sec.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Habitual activity1	Monitoring habitual activity during hospital stay. Time spent walking, sitting and laying in hours/day. Measured over 3-5 consecutive days.	one or more of :Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Habitual activity2	Monitoring habitual activity during hospital stay. Distance walked in meters/day. Measured over 3-5 consecutive days.	one or more of :Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Sensory-tactile	Sensory acuity will be measured using Semmes-Weinstein monofilament. Outcome is in grams.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Coordination-LE1	LEMOCOT- Lower Extremity Motor Coordinating Test. Outcome is the number of touches (count).	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Coordination-LE2	LEMOCOT- Lower Extremity Motor Coordinating Test. Outcome is the touches' errors (distance from the middle of the target), measured in mm. To measure errors, the LEMOCOT will be performed on an array of force sensors (Zebris FDM-T Treadmill, Zebris Medical GmbH, Germany) that detects the touches position.	Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Reticulospinal excitability	Response enhancement following a startling auditory stimuli (StartReact measure). Reaction time is measured in msec based on EMG signal from the wrist extensors and biceps (gtech USB-Amp). The StartReact measure is the enhancement in reaction time in the startle condition (LED+105Db auditory stimulus) compared to a control condition (LED+80Db auditory stimulus)	one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Muscle controllability1	The ability to control a cursor in a virtual environment using EMG recordings from wrist extensors and biceps (Trigno Wireless EMG System, Delsys, USA). Outcome is success rate in %.	one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Muscle controllability2	The ability to control a cursor in a virtual environment using EMG recordings from wrist extensors and biceps (Trigno Wireless EMG System, Delsys, USA). Outcome is time to target sec.	one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Muscle controllability3	The ability to control a cursor in a virtual environment using EMG recordings from wrist extensors and biceps (Trigno Wireless EMG System, Delsys, USA). Outcome is path length in cm.	one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Neuroimaging	CT/MRI based structural neuroimaging. Outcomes are the areas affected by stroke.	one or more of :1-month, 3-month, 6-month, 1-year

Collaborators and Investigators

• Sponsor: Adi Negev-Nahalat Eran
• Collaborators: Technion, Israel Institute of Technology; Ben-Gurion University of the Negev
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: June 1, 2024
• First Posted (Actual): June 4, 2024

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: ADINEGEV-2023_106; SIS70023GR0026 (Other Grant/Funding Number: KB6NZDMMP3N8)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No