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.
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
200
non-interventional
Rambam/Technion
Haifa, Israel
NOT_YET_RECRUITINGAdi-Negev Nahalat Eran
Ofakim, Israel
RECRUITINGAl-Ahli hospital
Hebron, Palestinian Territories
NOT_YET_RECRUITINGFugl-Meyer Assessment (FMA)
Fugl-Meyer Assessment: Motor score is on a 0-100 scale. High score is better.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (<3weeks), 1-year
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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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.)
Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Rehabilitation-time
Time, in minutes, of each therapy session.
Time frame: 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.
Time frame: one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Supporting data-age
Age at admission, in years.
Time frame: Baseline
Supporting data-sex
Biological Male or Female
Time frame: Baseline
Supporting data-time1
time from stroke onset in days
Time frame: 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.
Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
anthropometric data-height
Height in cm
Time frame: Baseline
anthropometric data-weight
Weight in kg
Time frame: Baseline
supporting data-directional
affected brain side: L/R/Both affected body side: L/R/Both hand dominance: L/R leg dominance: L/R
Time frame: Baseline
supporting data-medical history
Any relevant history of illnesses.
Time frame: Baseline
Cognition-impairment
Montreal Cognitive Assessment (MoCA). 0-30 scale with higher values indicate better cognitive state.
Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Cognition-inhibition1
Percent correct responses in an anti-saccade computerized task.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 %.
Time frame: 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 %.
Time frame: 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.
Time frame: 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.
Time frame: baseline
Balance-postural steadiness1
Postural Sway (Zebris FDM-T Treadmill, Zebris Medical GmbH, Germany). Outcome is sway range in mm.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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)
Time frame: 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 %.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: one or more of :1-month, 3-month, 6-month, 1-year