Cerebral Vascular Accident (CVA)/StrokeRESTRONCT06441552
The Natural History of Recovery After Stroke
An observational study of Cerebral Vascular Accident (CVA)/Stroke, run by Adi Negev-Nahalat Eran at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Vascular Accident (CVA)/Stroke
- What is being tested?
- non-interventional
- How many people
- 200 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Feb 2024to Jan 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stroke survivors and healthy adults.
Who may be able to join
- >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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Lior Smuelof, PhD contact
3 sites in 2 countries
Israel2 sites, 2 recruiting
- Not yet recruiting
Rambam/Technion
Haifa
David Tanne, MD, D_TANNE@rambam.health.gov.il
Firas Mawase, PhD, 972-54-782-3017, mawasef@bm.technion.ac.il
- Recruiting
Adi-Negev Nahalat Eran
Ofakim
Shilo Kramer, MD, shilok@adi-il.org
Simona Bar-Haim, PhD, barhaims@bgu.ac.il
Palestinian Territories1 site, 1 recruiting
- Not yet recruiting
Al-Ahli hospital
Hebron
Akram Amro, PhD, akram1973@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Vascular Accident (CVA)/Stroke
- Being tested
- non-interventional
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-interventionalOther
non-interventional
| Study group | Role | What they receive |
|---|---|---|
| Ofakim | Non-interventional group, recruited at Adi-Negev Rehabilitation Center, Israel. Receives: Other: non-interventional | |
| Haifa | Non-interventional group, recruited at Rambam Health Care Campus, Israel. Receives: Other: non-interventional | |
| Hebron | Non-interventional group, recruited through Green Land Society for Health Development, Palestine. Receives: Other: non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment (FMA)
Fugl-Meyer Assessment:
Motor score is on a 0-100 scale. High score is better.
Measured: 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.
Measured: 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.
Measured: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Secondary outcomes (51)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.)
Measured: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Rehabilitation-time
Time, in minutes, of each therapy session.
Measured: 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.
Measured: one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Supporting data-age
Age at admission, in years.
Measured: Baseline
Supporting data-sex
Biological Male or Female
Measured: Baseline
Supporting data-time1
time from stroke onset in days
Measured: 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.
Measured: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
anthropometric data-height
Height in cm
Measured: Baseline
anthropometric data-weight
Weight in kg
Measured: Baseline
supporting data-directional
affected brain side: L/R/Both affected body side: L/R/Both hand dominance: L/R leg dominance: L/R
Measured: Baseline
supporting data-medical history
Any relevant history of illnesses.
Measured: Baseline
Cognition-impairment
Montreal Cognitive Assessment (MoCA). 0-30 scale with higher values indicate better cognitive state.
Measured: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Cognition-inhibition1
Percent correct responses in an anti-saccade computerized task.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 %.
Measured: 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 %.
Measured: 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.
Measured: 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.
Measured: baseline
Balance-postural steadiness1
Postural Sway (Zebris FDM-T Treadmill, Zebris Medical GmbH, Germany). Outcome is sway range in mm.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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 %.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: one or more of :1-month, 3-month, 6-month, 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Feb 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebral Vascular Accident (CVA)/StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Adi Negev-Nahalat Eran
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev, Technion, Israel Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Simona Bar-Haim, PhD, Principal investigator, Ben-Gurion University of the NegevLior Smuelof, PhD, Principal investigator, Ben-Gurion University of the NegevShirley Handelzalts, PhD, Principal investigator, Ben-Gurion University of the NegevFiras Mawase, PhD, Principal investigator, Technion, Israel Institute of TechnologyAkram Amro, PhD, Principal investigator, Green Land Society for Health Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441552
- Sponsor's protocol ID
- ADINEGEV-2023_106
- Other IDs
- SIS70023GR0026
- Acronym
- RESTRO
- Status last verified
- Sep 2025
- First submitted
- 30 Apr 2024
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
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.
PubMed 7845561Balasubramanian 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.
PubMed 26651329Collins 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.
PubMed 8224055