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NCT Number: NCT06441552

The Natural History of Recovery After Stroke

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rambam/Technion, Haifa, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-Interventional

Other

non-interventional

Primary outcomes

  1. Fugl-Meyer Assessment (FMA)

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    Fugl-Meyer Assessment:

    Motor score is on a 0-100 scale. High score is better.

  2. Action Research Arm Test (ARAT)

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    Action Research Arm Test Score is on a 0-57 scale. High score is better.

  3. 10-meter walk test (10MWT)

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    Outcome is the average walking velocity over 10 meters. Measured in m/sec.

Secondary outcomes

  1. National Institutes of Health Stroke Scale (NIHSS)

    Time frame: Baseline (<3weeks)

    measure of stroke severity on a 0-42 scale, with lower scores indicates lower severity (lower is better).

  2. The Stroke Self-Efficacy Questionnaire (SSEQ)

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    This is a self-reported ability perception scale. Outcome range is 0-130 with higher scores indicate a better self-perceived ability.

  3. The Nine Hole Peg Test (NHPT)

    Time frame: Baseline (<3weeks), 1-year

    This is an upper extremity dexterity test. Outcome is the time taken to complete the task. Measured in sec.

  4. The Functional Dexterity Test (FDT)

    Time frame: Baseline (<3weeks), 1-year

    This is an upper extremity dexterity test. Outcome is the time taken to complete the task. Measured in sec.

  5. The Behavioral Inattention Test (BIT)

    Time frame: Baseline (<3weeks)

    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.

  6. The Ashworth scale

    Time frame: Baseline (<3weeks)

    This instrument is used to detect spasticity (increased muscle tone). Outcome is 0-4 scale, with lower scores means better outcome (less spasticity).

  7. Kinetics-fingers1

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    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.

  8. Kinetics-fingers2

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    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.

  9. Kinetics-grip

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    Grip force will be measured using the microFET Digital HandGrip Dynamometer (Hoggan Scientific). Outcome is the maximal force in Newtons.

  10. Kinematics-reaching

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    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.

  11. Kinematics-duration

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    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.

  12. Kinematics-smoothness

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    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).

  13. Kinematics-Inter-joint coordination

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    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.

  14. Rehabilitation-intensity

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    Number of rehabilitative sessions per week, in total and for each modality separately (e.g., physical therapy, occupational therapy, etc.)

  15. Rehabilitation-time

    Time frame: one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    Time, in minutes, of each therapy session.

  16. Rehabilitation-period

    Time frame: one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    Period of time (in month) for which the participant received therapy.

  17. Supporting data-age

    Time frame: Baseline

    Age at admission, in years.

  18. Supporting data-sex

    Time frame: Baseline

    Biological Male or Female

  19. Supporting data-time1

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    time from stroke onset in days

  20. Supporting data-time2

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    other time periods (e.g., inpatient time, rehabilitation duration, etc.) in Months.

  21. anthropometric data-height

    Time frame: Baseline

    Height in cm

  22. anthropometric data-weight

    Time frame: Baseline

    Weight in kg

  23. supporting data-directional

    Time frame: Baseline

    affected brain side: L/R/Both affected body side: L/R/Both hand dominance: L/R leg dominance: L/R

  24. supporting data-medical history

    Time frame: Baseline

    Any relevant history of illnesses.

  25. Cognition-impairment

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    Montreal Cognitive Assessment (MoCA). 0-30 scale with higher values indicate better cognitive state.

  26. Cognition-inhibition1

    Time frame: one or more of : Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    Percent correct responses in an anti-saccade computerized task.

  27. Cognition-inhibition2

    Time frame: one or more of : Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    Reaction time (in msec) in an anti-saccade computerized task.

  28. Timed up and Go test (TUG)

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    Time taken to complete the TUG task. Measured in seconds.

  29. Gait Specific attentional profile (G-SAP)

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    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.

  30. Gait analysis-temporal

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    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.

  31. Gait analysis-spatial

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    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.

  32. Gait analysis-steadiness

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    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.

  33. Gaze-angle1

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    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.

  34. Gaze-angle2

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    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 %.

  35. Gaze-downward

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    Gaze behavior during walking using a mobile eye-tracker (Pupil Invisible, Pupil Labs, Germany). Time spent looking onto the walking surface. Outcome in %.

  36. Gaze-look-ahead distance

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    Gaze behavior during walking using a mobile eye-tracker (Pupil Invisible, Pupil Labs, Germany). Look-ahead distance. Outcome in meters.

  37. Balance-Berg

    Time frame: baseline

    Berg Balance Scale (BBS) measured on a 0-56 scale with higher score represent better outcome.

  38. Balance-postural steadiness1

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    Postural Sway (Zebris FDM-T Treadmill, Zebris Medical GmbH, Germany). Outcome is sway range in mm.

  39. Balance-postural steadiness2

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    Postural Sway (Zebris FDM-T Treadmill, Zebris Medical GmbH, Germany). Outcome is sway velocity in mm/sec.

  40. Balance-postural steadiness3

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    Postural Sway (Zebris FDM-T Treadmill, Zebris Medical GmbH, Germany). Outcome is sway area in mm^2.

  41. Balance-postural steadiness4

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    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.

  42. Habitual activity1

    Time frame: one or more of :Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    Monitoring habitual activity during hospital stay. Time spent walking, sitting and laying in hours/day. Measured over 3-5 consecutive days.

  43. Habitual activity2

    Time frame: one or more of :Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    Monitoring habitual activity during hospital stay. Distance walked in meters/day. Measured over 3-5 consecutive days.

  44. Sensory-tactile

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    Sensory acuity will be measured using Semmes-Weinstein monofilament. Outcome is in grams.

  45. Coordination-LE1

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    LEMOCOT- Lower Extremity Motor Coordinating Test. Outcome is the number of touches (count).

  46. Coordination-LE2

    Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    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.

  47. Reticulospinal excitability

    Time frame: one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    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)

  48. Muscle controllability1

    Time frame: one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    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 %.

  49. Muscle controllability2

    Time frame: one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    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.

  50. Muscle controllability3

    Time frame: one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

    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.

  51. Neuroimaging

    Time frame: one or more of :1-month, 3-month, 6-month, 1-year

    CT/MRI based structural neuroimaging. Outcomes are the areas affected by stroke.

Study contacts

Contact information is provided by the study sponsor or research team.

Lior Smuelof, PhD

CONTACT

[email protected]

Simona Bar-Haim, PhD

CONTACT

[email protected]

972-54-470-2553

Sponsors and collaborators

Lead sponsor

Adi Negev-Nahalat Eran

Other

Collaborators

  • Ben-Gurion University of the Negev
  • Technion, Israel Institute of Technology

Registry information

Official study title

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

Acronym: RESTRO

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2024
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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