Non-Interventional
Othernon-interventional
NCT Number: NCT06441552
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Observational
Rambam/Technion, Haifa, Israel
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
non-interventional
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.
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.
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.
Time frame: Baseline (<3weeks)
measure of stroke severity on a 0-42 scale, with lower scores indicates lower severity (lower is better).
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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).
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.
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.)
Time frame: one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Time, in minutes, of each therapy session.
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.
Time frame: Baseline
Age at admission, in years.
Time frame: Baseline
Biological Male or Female
Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
time from stroke onset in days
Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
other time periods (e.g., inpatient time, rehabilitation duration, etc.) in Months.
Time frame: Baseline
Height in cm
Time frame: Baseline
Weight in kg
Time frame: Baseline
affected brain side: L/R/Both affected body side: L/R/Both hand dominance: L/R leg dominance: L/R
Time frame: Baseline
Any relevant history of illnesses.
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.
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.
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.
Time frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year
Time taken to complete the TUG task. Measured in seconds.
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.
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.
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.
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.
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.
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 %.
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 %.
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.
Time frame: baseline
Berg Balance Scale (BBS) measured on a 0-56 scale with higher score represent better outcome.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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)
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 %.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Lior Smuelof, PhD
CONTACT
Simona Bar-Haim, PhD
CONTACT
Adi Negev-Nahalat Eran
Other
Learning the Natural History of Recovery After Stroke - Cognitive, Motor and Sensory Function
Acronym: RESTRO
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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