Cerebral Vascular Accident (CVA)/Stroke
Conditions
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.
Interventions
OTHERnon-interventional
non-interventional
Sponsors
Ben-Gurion University of the Negev
Technion, Israel Institute of Technology
Adi Negev-Nahalat Eran
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment (FMA) | 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. |
| Action Research Arm Test (ARAT) | 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. |
| 10-meter walk test (10MWT) | Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year | Outcome is the average walking velocity over 10 meters. Measured in m/sec. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Stroke Self-Efficacy Questionnaire (SSEQ) | 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. |
| The Nine Hole Peg Test (NHPT) | Baseline (<3weeks), 1-year | This is an upper extremity dexterity test. Outcome is the time taken to complete the task. Measured in sec. |
| The Functional Dexterity Test (FDT) | Baseline (<3weeks), 1-year | This is an upper extremity dexterity test. Outcome is the time taken to complete the task. Measured in sec. |
| The Behavioral Inattention Test (BIT) | 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. |
| The Ashworth scale | 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). |
| Kinetics-fingers1 | 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. |
| Kinetics-fingers2 | 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. |
| Kinetics-grip | 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. |
| Kinematics-reaching | 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. |
| Kinematics-duration | 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. |
| Kinematics-smoothness | 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). |
| Kinematics-Inter-joint coordination | 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. |
| Rehabilitation-intensity | 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.) |
| Rehabilitation-time | one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year | Time, in minutes, of each therapy session. |
| Rehabilitation-period | 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. |
| Supporting data-age | Baseline | Age at admission, in years. |
| Supporting data-sex | Baseline | Biological Male or Female |
| Supporting data-time1 | Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year | time from stroke onset in days |
| Supporting data-time2 | Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year | other time periods (e.g., inpatient time, rehabilitation duration, etc.) in Months. |
| anthropometric data-height | Baseline | Height in cm |
| anthropometric data-weight | Baseline | Weight in kg |
| supporting data-directional | Baseline | affected brain side: L/R/Both affected body side: L/R/Both hand dominance: L/R leg dominance: L/R |
| supporting data-medical history | Baseline | Any relevant history of illnesses. |
| Cognition-impairment | Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year | Montreal Cognitive Assessment (MoCA). 0-30 scale with higher values indicate better cognitive state. |
| Cognition-inhibition1 | one or more of : Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year | Percent correct responses in an anti-saccade computerized task. |
| Cognition-inhibition2 | one or more of : Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year | Reaction time (in msec) in an anti-saccade computerized task. |
| Timed up and Go test (TUG) | Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year | Time taken to complete the TUG task. Measured in seconds. |
| Gait Specific attentional profile (G-SAP) | 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. |
| Gait analysis-temporal | 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. |
| Gait analysis-spatial | 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. |
| Gait analysis-steadiness | 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. |
| Gaze-angle1 | 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. |
| Gaze-angle2 | 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 %. |
| Gaze-downward | 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 %. |
| Balance-postural steadiness1 | 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. |
| Balance-postural steadiness2 | 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. |
| Balance-postural steadiness3 | 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. |
| Balance-postural steadiness4 | 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. |
| Habitual activity1 | 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. |
| Habitual activity2 | 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. |
| Sensory-tactile | Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year | Sensory acuity will be measured using Semmes-Weinstein monofilament. Outcome is in grams. |
| Coordination-LE1 | Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year | LEMOCOT- Lower Extremity Motor Coordinating Test. Outcome is the number of touches (count). |
| Coordination-LE2 | 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. |
| Reticulospinal excitability | 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) |
| Gaze-look-ahead distance | 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. |
| Muscle controllability2 | 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. |
| Muscle controllability3 | 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. |
| Neuroimaging | one or more of :1-month, 3-month, 6-month, 1-year | CT/MRI based structural neuroimaging. Outcomes are the areas affected by stroke. |
| Muscle controllability1 | 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 %. |
| Balance-Berg | baseline | Berg Balance Scale (BBS) measured on a 0-56 scale with higher score represent better outcome. |
| National Institutes of Health Stroke Scale (NIHSS) | Baseline (<3weeks) | measure of stroke severity on a 0-42 scale, with lower scores indicates lower severity (lower is better). |
Countries
Israel, Palestinian Territories
Contacts
Primary ContactSimona Bar-Haim, PhD
Backup ContactLior Smuelof, PhD
Outcome results
None listed