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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD095187 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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A large number of post-stroke survivors cannot functionally use their paretic upper extremity (UE). This study therefore investigates effects of device-assisted practice of activities of daily living (ADL) in a close-to-normal pattern on UE motor recovery in individuals with moderate to severe stroke by measuring intervention-induced changes in clinical outcomes, UE kinematics, and functional and morphologic neuroplasticity. Positive findings may impact current clinical practice by pushing towards implementing device-assisted practice of ADLs and have the potential to benefit a large population.
Thirty subjects for each group will be recruited. A REDCap database for this study will be setup to manage every step involved in the protocol. All the potential subjects will go through standardized steps:
Experienced research team members will conduct pre-screening of subjects from the Clinical Neuroscience Research Registry, which is maintained by the Physical Therapy and Human Movement Sciences (PTHMS) department at Northwestern University. Recruitment will also be conducted via flyers in various rehabilitation centers in the Chicagoland. The investigators will start the recruitment by an 'initial phone contact' to introduce the study and confirm the interests for participation. Once confirmed, a standardized 'phone screening' will be followed to partially go through the questions related to eligibility. Once passed all the questions over phone, a lab-based eligibility test will be scheduled at the department of PTHMS. During the first visit, the investigators will explain the study and answer all the related questions from potential participants. The paper consent form will be signed and dated by the individual once he/she agrees to participate, and a copy of the signed consent form will be given to the participant. Following consent, the blinded assessor will determine the eligibility using the inclusion and exclusion criteria.
The treating therapist will determine the settings of reliable and intuitive control of the paretic hand (ReIn-Hand) device. A 3D scan will be made to enable the produce of subject-specific ReIn-Hand device.
Qualified participants will undergo 2 baseline clinical assessments within 2 weeks.
All the enrolled participants will be randomly assigned to the either experimental or control group with the balance in Upper Extremity Fugl-Meyer Assessment (FMA) scores of the 2 groups. Randomization results will be concealed to the assessor all the time and will be only assessable to treating therapists and biostatisticians on the day for the first session of the assigned intervention.
The investigators will collect individual's magnetic resonance imaging (MRI) data and electroencephalogram (EEG) data within two weeks prior to the intervention. MRI scans will be performed at Northwestern University's Center for Translation Imaging. For EEG data collection, the investigators will first measure a subject's maximal voluntary torque (MVT) in the direction of shoulder abduction (SABD), maximum finger grasping forces of the paretic upper extremity (UE), maximum hand pentagon area, defined as the area formed by the tips of thumb and fingers, of the non-paretic hand when the hand is maximally stretched on a tabletop, and subject's upper- and forearm lengths for normalization purposes. For the hand opening task, participants' arm will be rested on the virtual table at the home position. Participants will relax in the home position for 5-7s and then to self-initiate maximal hand opening for 2s, without blinking or eye moving. For the hand opening with SABD loading, participants will perform the maximal hand opening while lifting the arm above table against 50% of his/her SABD MVT after 5-7s resting on the home position. A set of 60-70 trials will be collected for each condition, in a block randomized way (20-30 trials per block). Rest periods of ~15 s between trials and ~10 min between blocks will be included to avoid fatigue.
Intervention All participants will participate in a 24-session intervention, ~2 hours per session, 3 sessions per week, for 8 weeks in total. Research participants, training PTs, and clinical evaluators will be blind to group assignment.
For all intervention, research participants will be seated with straps across the chest and waist to prevent unwanted trunk movement. The training technicians will stretch the paretic UE for up to 15 minutes. The ReIn-Hand device will be attached to the paretic UE and then positioned at a home position in 75° SABD, 30° shoulder flexion, and 60° elbow flexion.
The first session will be a 'parameter adjusting session', during which the training PT will determine training parameters, including: 1) SABD load, 2) target(jar) distance, 3) jar width, 4) jar weight, 5) jar height, and 6) jar orientation. These training parameters will be established both on the table condition and using a robot. The robot modulates the supporting force in Z-direction applied to the arm while participants are required to lift the arm, thus changing the SABD load. The SABD load will be set as the maximum load that allows the participant to actively reach the target distance and achieve a ReIn-Hand mediated hand opening no less than 4 cm between the tips of the thumb and index fingers. After establishing SABD load, all the additional parameters (2-6) will be set, first with the established SABD load as following: Target distance is 70% of the distance of the max reach of the paretic UE when fully supported on a frictionless table created by the robot; Jar width will be increased in 0.5 cm increments, by adding padding around the jar, to the max width the participant can achieve with the ReIn-Hand; Jar height (i.e., distance from the lowest part of the jar to the surface of the table) will be set as 2 cm increments to the max height the participant can successfully (and painlessly) reach the jar; Jar orientation (i.e., the relation of the long axis of the jar to the table surface) will be set as 2° increments to the maximum amount that allows the participant to successfully grasp the jar; and Jar weight will be increased in 100 g increments, stopping if the participant experiences pain or cannot lift the jar. The Training PT will then repeat the steps 2-6 to determine these parameters (2-6); however, this time without robot support and thus using a height-adjustable table.
Once the intervention parameters are set, the training technician will guide the participant to perform 'reaching-grasping-retrieving-and- releasing' (GR3) activities using these parameters. Participants in the experimental group will be trained using the robot. Their forearm of a participant will be attached to an orthosis, which will be firmly attached to the robot. Participants in the experimental group will be trained on a regular table. All training sessions will consist of 40 trials (about 1 hour) of GR3 activities, which include: 1) Reaching towards a plastic jar (diameter=3cm, weight=30g when empty); 2) Activating finger/wrist extensor muscles to trigger the ReIn-Hand device, which in turn assists the opening of the paretic hand while reaching; 3) Grasping the jar; 4) Retrieving the jar to the home position and placing it on the table; and 5) Releasing the jar. To avoid fatigue, a resting time of 20-30 seconds will be provided between trials. Participants in the control group will be encouraged to perform GR3 activities with the arm above the table.
A successful trial requires the completion of all five tasks required during one trial: Reaching towards a plastic jar, triggering the ReIn-Hand device, grasping the jar, retrieving the jar to the home position, and placing it on the table, and releasing the jar. An unsuccessful trial is defined as the failure to complete one of the five tasks during one trial. The result of each of the 40 trials will be recorded by the training technician.
The Training PT will review the training performance after each session to determine if adjustment of parameters is necessary for the next session. If a participant successfully completes 30/40 trials in 2 successive sessions, the training PT will re-adjust all the parameters at the following session to progressively challenge the participant. New parameters then will be implemented by the training technician during the following session.
Weekly outcome measures. The blinded clinical assessor will measure the following outcomes weekly: Box and Blocks Test, Quantitative Measure of Hand Opening and Closing, and Cutaneous Sensory Touch Threshold.
The blinded clinical assessor will check participant's sensory and motor function using the same clinical assessments as that used for baseline within 1 week after the intervention.
Within one week after the end of intervention, the investigators will repeat the neural imaging and biomechanical data collection, using the same protocols as stated before.
Three-month follow-up. Three months after the intervention, the blinded clinical assessor will check participant's sensory and motor function using the same clinical assessments as stated before. To maximize the retention, the investigators will have a clear and standardized communication of our expectations of the participant over the course of the study. For each participant, the project coordinator will generate a personal timetable with scheduling of experiments. Flexibility of appointments will be included. Finally, the project coordinator will call the participants about at 7 days and then 1 day before the scheduled 3-month follow up to remind the last assessment.
AE and SAE reporting Adverse event (AE) report form has been implemented in the RedCap database, which can be used at any time. The investigators will report all AEs to the Northwestern Institutional Review Board (IRB) per established policies and requirements. The investigators will create AE reports every six months to review for trends and troubleshoot any issues that arise and require study protocol revision. If any AEs are reported that require follow-up medical care, the investigators will immediately refer the participant back to his/her physician team.
Serious adverse events (SAEs) that are unanticipated, serious, and possibility related to the study intervention will be reported to the Independent Monitor(s), IRB, and National Institute of Child Health and Human Development (NICHD) in accordance with requirements. Unexpected fatal or life-threatening AEs related to the intervention will be reported to the Northwestern IRB in accordance with IRB requirements within 24 hours, and to the NICHD program Officer with 7 days. Other serious and unexpected AEs related to the intervention will also be reported to the Northwestern IRB in accordance with IRB requirements within 24 hours, and to the NICHD program Official within 15 days. Anticipated or unrelated SAEs will be handled in a less urgent manner but will be reported to the Independent Monitor(s), IRB, NICHD, and other oversight organizations in accordance with their requirements. In the annual AE summary, the Independent Monitor(s) Report will state that they have reviewed all AE reports.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReIn-hand and robot | Experimental | The participant will practice "reach, grasp, retrieve, and release (GR3)" a plastic jar for 40 trials per session, with the assistance of ReIn-hand to open their paretic hand and of robot to reduce the shoulder load. |
|
| ReIn-Hand | Active Comparator | The participant will practice "reach, grasp, retrieve, and release (GR3)" a plastic jar for 40 trials per session, with the assistance of ReIn-hand to open their paretic hand. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReIn-Hand | Device | ReIn-Hand assists the hand opening |
|
| Measure | Description | Time Frame |
|---|---|---|
| Box and Blocks Test (BBT) | Individuals are seated at a table, facing a rectangular box that is divided into two square compartments of equal dimensions by means of a partition. One hundred and fifty small wooden cubes or blocks are placed in one compartment or the other. The individual is instructed to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. The Box and Blocks Test (BBT) is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period. Patients hand must cross over the partition in order for a point to be given, and blocks that drop or bounce out of the second compartment onto the floor are still rewarded with a point. Multiple blocks carried over at the same time count as a single point. The minimum score is 0 and the theoretical maximum number is 150. Higher scores mean a better outcome (better manual dexterity). | Within 1 week after conclusion of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Upper Extremity Fugl-Meyer Assessment Score | The Fugl-Meyer Assessment (FMA) of Motor Recovery after stroke evaluates and measures motor impairment in post-stroke hemiplegic patients. Different movements are judged on the individuals ability to perform with full capacity, limited capacity, or total inability to complete the required movements. We will use the upper extremity part of FMA, with scores ranging from 0-66, 0 and 66 representing no and normal residual upper extremity motor function, respectively. Higher scores indicate a better outcome. The results are from the measure collected 1 time immediately after conclusion of the intervention (within 1 week). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Yao, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 645 N Michigan Ave, Suite 1100 | Chicago | Illinois | 60611 | United States | ||
| Northwestern University, Dept. of PTHMS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40616111 | Derived | Drogos JM, Carmona C, Arceo R, Yao J. Effects of device-assisted practice of activities of daily living in a close-to-normal pattern on upper extremity motor recovery in individuals with moderate to severe stroke: study protocol of a randomized control trial. Trials. 2025 Jul 4;26(1):238. doi: 10.1186/s13063-025-08930-7. | |
| 37314323 | Derived | Carmona C, Sullivan JE, Arceo R, Drogos J, Besser S, Gutierrez S, Jeteric Z, Wyman J, Yao J. Development and Preliminary Validity Study of a Modified Version of the Upper Extremity Fugl-Meyer Assessment for Use in Telerehabilitation. J Neurol Phys Ther. 2023 Oct 1;47(4):208-216. doi: 10.1097/NPT.0000000000000447. Epub 2023 Jun 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reliable and Inuitive (ReIn)-Hand and Robot | The participant will practice "reach, grasp, retrieve, and release (GR3)" a plastic jar for 40 trials per session, with the assistance of ReIn (Reliable and Intuitive)-hand to open their paretic hand and of robot to reduce the shoulder load. ReIn-Hand: ReIn-Hand assists the hand opening Robot: Robot supports the shoulder load |
| FG001 | Reliable and Inuitive (ReIn)-Hand | The participant will practice "reach, grasp, retrieve, and release (GR3)" a plastic jar for 40 trials per session, with the assistance of ReIn-hand to open their paretic hand. ReIn-Hand: ReIn-Hand assists the hand opening |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ReIn-hand and Robot | The participant will practice "reach, grasp, retrieve, and release (GR3)" a plastic jar for 40 trials per session, with the assistance of ReIn-hand to open their paretic hand and of robot to reduce the shoulder load. ReIn-Hand: ReIn-Hand assists the hand opening Robot: Robot supports the shoulder load |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Box and Blocks Test (BBT) | Individuals are seated at a table, facing a rectangular box that is divided into two square compartments of equal dimensions by means of a partition. One hundred and fifty small wooden cubes or blocks are placed in one compartment or the other. The individual is instructed to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. The Box and Blocks Test (BBT) is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period. Patients hand must cross over the partition in order for a point to be given, and blocks that drop or bounce out of the second compartment onto the floor are still rewarded with a point. Multiple blocks carried over at the same time count as a single point. The minimum score is 0 and the theoretical maximum number is 150. Higher scores mean a better outcome (better manual dexterity). | Posted | Mean | Standard Deviation | blocks | Within 1 week after conclusion of intervention |
|
Adverse event data was collected from enrollment through study completion, an average of six months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ReIn-hand and Robot | The participant will practice "reach, grasp, retrieve, and release (GR3)" a plastic jar for 40 trials per session, with the assistance of ReIn-hand to open their paretic hand and of robot to reduce the shoulder load. ReIn-Hand: ReIn-Hand assists the hand opening Robot: Robot supports the shoulder load |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| EFF122 arm pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Participant reported to research assistants pain in his right arm following the conclusion of that day's intervention. He could not describe pain, notes that it is mostly in his upper arm and a little bit in his hand. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jun Yao, PhD | Northwestern University | 312-908-9060 | j-yao4@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2025 | Dec 12, 2025 | Prot_SAP_008.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 24, 2023 | Apr 21, 2023 | ICF_007.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065287 | Robotic Surgical Procedures |
| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D012371 | Robotics |
| D001331 | Automation |
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| Robot | Device | Robot supports the shoulder load |
|
|
| Within 1 week after conclusion of intervention |
| Chedoke McMaster Stroke Assessment (CMSA) Hand Subscale | This test evaluates the stage of motor recovery for the paretic hand following a stroke. Scores range from 0-7, with 0 representing no function and 7 representing full function of the hand. Higher scores mean better outcome. | Within 1 week after conclusion of intervention |
| Action Research Arm Test (ARAT) | The ARAT test is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). ARAT is a validated quick assessment of the paretic arm's functional disabilities, which offers uncomplicated and comprehensive feedback on the function of their arm, hand and fingers. Scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance. | Within 1 week after conclusion of intervention |
| Kinaesthesia Subscale of Nottingham Sensory Assessment | The kinaesthesia subscale measures an individual's ability to sense movement, direction of movement, and position sense at a given joint. The assessment involves the tester initiating passive movement in the individuals affected finger, wrist, elbow, and shoulder; while the individual attempts to match those movement with their opposite extremity. The total score for this subscale (Kinaesthesia) ranges from 0 to 12. Higher scores indicates better outcome. | Within 1 week after conclusion of intervention |
| Cutaneous Sensory Touch Threshold Using Semmes-Weinstein Monofilaments | The monofilament test is a threshold assay used to determine the minimum stimulation or force that can be felt by a subject. This test is also known as light touch/protective touch/deep pressure testing in the hands. There are 6 monofilament sizes used to test, with each having a corresponding target force in grams. They are as follows, with the target force in grams in parentheses: 2.83 (0.07) - Normal 3.61 (0.4) - Diminished Light Touch 4.31 (2) - Diminished Protective Sensation 4.56 (4) - Loss of Protective Sensation 5.07 (10) - Loss of Protective Sensation 6.65 (300) - Deep Pressure Sensation only For any participant who was unable to sense above 6.65, we applied the score of 7.00 in the analysis. 6 parts of the hand were tested. These 6 values were then averaged to calculate the total hand score. The minimum score for the test is 2.83 and the maximum score is 7.00. Lower scores indicate a better outcome. | Within 1 week after conclusion of intervention |
| Motor Activity Log (MAL) | The Motor Activity Log is a semi-structured interview to assess arm function. Individuals are asked to rate Quality of Movement (QoM) and Amount of Use (AoU) during 30 daily functional tasks, which include object manipulation as well as the use of the affected arm during gross motor activities. Items scored on a 6-point ordinal scale. For the AoU scale, 0 indicates weaker arm was not used at all for activity (never) and 6 indicates ability to use the weaker arm for that activity was as good as before the stroke (normal). For the QoM scale, 0 indicates the weaker arm was not used at all for that activity (never) and 6 indicates that the ability to use the weaker arm for that activity was as good as before the stroke (normal) Higher scores indicate that current function most closely matches unimpaired function prior to the stroke event. | Within 1 week after conclusion of intervention |
| Stroke Impact Scale (SIS) Stroke Recovery Question | The Stroke Impact Scale (SIS) Stroke Recovery Question is one item that asks the participant to rate on a scale from 0-100 (with 0 meaning no recovery and 100 meaning full recovery) how much they feel they have recovered from their stroke. Higher scores correspond to better outcomes (closer to full recovery following a stroke). | Within 1 week after conclusion of intervention |
| Stereognosis Subscale of Nottingham Sensory Assessment | Stereognosis refers to the ability to identify or perceive the material quality of objects through touch alone, in the absence of visual or auditory stimuli. The individual will be asked to use their paretic hand to identify a number of everyday items through touch alone. Scores of this subscale range from 0-22, with 22 indicating full stereognosis function and 0 representing complete absence of stereognosis. Higher scores indicate better outcomes. | Within 1 week after conclusion of intervention |
| Quantitative Measure of Hand Closing Force (QMHC) | Individual is instructed to lay their affected arm on the table or pillow (depending on participant comfort level). A hand dynamometer is then placed in the affected hand and participant is instructed to close their fist as tight as they can. The dynamometer records grip strength and measures from 0-200 lbs. The test is then repeated with the unaffected arm and hand. Higher numbers correspond to better outcomes (grip strength is close to or is at same level as before stroke). | Within 1 week after conclusion of intervention |
| Fractional Anisotropy (FA) of Bilateral Cortico-fugal Tracts | Fractional anisotropy (FA) is a unitless scalar (range: 0-1) derived from diffusion tensor imaging (DTI) that reflects the degree of directional water diffusion within white matter. It is calculated as a normalized ratio of diffusion along principal versus non-principal directions. Higher FA values indicate greater microstructural organization and integrity of the corticospinal tract (CST), whereas lower values suggest reduced integrity. FA was measured in both lesioned (affected by stroke) and non-lesioned CSTs, identified using a seed mask at the posterior limb of the internal capsule (PLIC). | Within 1 week after conclusion of intervention |
| Hand Pentagon Area (HPA) While Opening With or Without Lifting | This metric quantifies the areas formed by the thumb and fingertips during maximally opening the paretic hand with or without lifting. Hand pentagon area (HPA) is a measure of hand opening ability, collected with Ascension TrakStar motion monitoring equipment. Sensors were placed on each fingertip, palm, wrist, and forearm. The participant was then asked to open their hands as wide as they can. The area (in mm2) was calculated as the sum of the surface area of three triangles formed by the participant's fingertip sensor locations in 3D space: thumb-index-middle, thumb-middle-ring, and thumb-ring-pinky. The maximum HPA presented during each Hand Opening trial was calculated. Higher values correspond to better outcomes (more finger extension/hand opening achievable). | Within 1 week after conclusion of intervention |
| Global Rating of Change (GROC) | The Global Rating of Change is an outcome measure that is used to evaluate improvements in a patient's condition (in this case, their arm function), following an intervention. It has only one item, and is scored on a 15-point self-report scale, with -7 indicating symptoms are a very great deal worse, 0 indicating that no improvement or worsening has been noted, and 7 indicating symptoms are a very great deal better. Negative values indicate worsening symptoms and positive values indicate improving symptoms. | Within 1 week after conclusion of intervention |
| Chicago |
| Illinois |
| 60611 |
| United States |
| ReIn-Hand |
The participant will practice "reach, grasp, retrieve, and release (GR3)" a plastic jar for 40 trials per session, with the assistance of ReIn-hand to open their paretic hand. ReIn-Hand: ReIn-Hand assists the hand opening |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Box and Blocks Test | Individuals are seated at a table, facing a rectangular box that is divided into two square compartments of equal dimensions. 150 small wooden cubes or blocks are placed in one compartment. The individual is instructed to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. It is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period. Minimum score is 0 and the theoretical maximum number is 150. Higher scores mean a better outcome (better manual dexterity). | Mean | Standard Deviation | blocks |
|
| Fugl-Meyer Motor Assessment Upper Extremity motor part | The Fugl-Meyer Assessment (FMA) of Motor Recovery after stroke evaluates and measures motor impairment in post-stroke hemiplegic patients. Different movements are judged on the individuals ability to perform with full capacity, limited capacity, or total inability to complete the required movements. We will use the upper extremity part of FMA, with scores ranging from 0-66, 0 and 66 representing no and normal residual upper extremity motor function, respectively. Higher scores indicate a better outcome. | Mean | Standard Deviation | points |
|
| Chedoke Mcmaster Stroke Assessment Hand Subscale | This test evaluates the stage of motor recovery for the paretic hand following a stroke. Scores range from 0-7, with 0 representing no function and 7 representing full function of the hand. Higher scores mean better outcome. | Mean | Standard Deviation | points |
|
| Action Research Arm Test | The ARAT test is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). ARAT is a validated quick assessment of the paretic arm's functional disabilities, which offers uncomplicated and comprehensive feedback on the function of their arm, hand and fingers. Scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance. | Mean | Standard Deviation | points |
|
| Kinaesthesia subscale of Nottingham Sensory Assessment | The kinaesthesia subscale of the Nottingham Sensory Assessment measures an individual's ability to sense movement, direction of movement, and position sense at a given joint. The assessment involves the tester initiating passive movement in the individuals affected finger, wrist, elbow, and shoulder; while the individual attempts to match those movement with their opposite extremity. The total score for this subscale (kinaesthesia) ranges from 0 to 12. Higher scores indicates better outcome. | Mean | Standard Deviation | points |
|
| Cutaneous Sensation Touch Testing | This test is a threshold assay used to determine the minimum stimulation or force that can be felt by a subject. There are 6 monofilament sizes corresponding to different target force in grams and range from 2.83 (0.07) - Normal to 6.65 (300) - Deep Pressure Sensation only. For any participant who was unable to sense above 6.65, we applied the score of 7.00 in the analysis. 6 parts of the hand were tested. These 6 values were then averaged to calculate the total hand score. The minimum score for the test is 2.83 and the maximum score is 7.00. Lower scores indicate a better outcome. | Mean | Standard Deviation | points |
|
| Motor Activity Log | The Motor Activity Log is a semi-structured interview to assess arm function during 30 daily tasks, with 2 subscales: Quality of Movement (QoM) & Amount of Use (AoU). Items scored on a 6-point ordinal scale. For the both AoU and QoM scale, 0 indicates weaker arm was not used at all for activity (never). For AoU scale, 6 indicates ability to use the weaker arm for that activity was as good as before the stroke (normal). For the QoM scale, 6 indicates that the ability to use the weaker arm for that activity was as good as before the stroke (normal) Higher scores mean better outcomes. | Mean | Standard Deviation | points |
|
| Stroke Impact Scale (SIS) Stroke Recovery Question | The Stroke Impact Scale (SIS) Stroke Recovery Question is one item that asks the participant to rate on a scale from 0-100 (with 0 meaning no recovery and 100 meaning full recovery) how much they feel they have recovered from their stroke. Higher scores correspond to better outcomes (closer to full recovery following a stroke). | Mean | Standard Deviation | units on a scale |
|
| Stereognosis subscale of Nottingham Assessment of Somato-Sensations | The Stereognosis subsection of the Nottingham Sensory Assessment measures stereognosis, the ability to identify or perceive the material quality of objects through touch alone, in the absence of visual or auditory stimuli. The individual will be asked to use their paretic hand to identify a number of everyday items through touch alone. Scores of this subscale range from 0-22, with 22 indicating full stereognosis function and 0 representing complete absence of stereognosis. Higher scores indicate better outcomes. | Mean | Standard Deviation | points |
|
| Quantitative Measure of Hand Closing Force (QMHC) | Due to time limitations for each session, not every subject's data was measured. | Mean | Standard Deviation | lbs |
|
| Fractional Anisotropy (FA) of Bilateral Cortico-fugal Tracks | Fractional anisotropy (FA) is a unitless scalar (range: 0-1) derived from diffusion tensor imaging (DTI) that reflects the degree of directional water diffusion within white matter. It is calculated as a normalized ratio of diffusion along principal versus non-principal directions. Higher FA values indicate greater microstructural organization and integrity of the corticospinal tract (CST), whereas lower values suggest reduced integrity. FA was measured in both lesioned (affected by stroke) and non-lesioned CSTs, identified using a seed mask at the posterior limb of the internal capsule. | Data could not be collected on all participants due to participant limitations. | Mean | Standard Deviation | Ratio |
|
| Hand Pentagon Area (HPA) While Opening With or Without Lifting | This is a measure of hand opening ability, collected with Ascension TrakStar motion monitoring equipment. Sensors were placed on each fingertip, palm, wrist, and forearm. The participant was then asked to open their hands as wide as they can. The area (in mm2) was calculated as the sum of the surface area of three triangles formed by the participant's fingertip sensor locations in 3D space: thumb-index-middle, thumb-middle-ring, and thumb-ring-pinky. The maximum HPA presented during each Hand Opening trial was calculated. Higher values correspond to better outcomes. | Due to time limitations for each session, not every subject's data was measured. | Mean | Standard Deviation | mm^2 |
|
| ReIn-hand and Robot |
The participant will practice "reach, grasp, retrieve, and release (GR3)" a plastic jar for 40 trials per session, with the assistance of ReIn-hand to open their paretic hand and of robot to reduce the shoulder load. ReIn-Hand: ReIn-Hand assists the hand opening Robot: Robot supports the shoulder load |
| OG001 | ReIn-Hand | The participant will practice "reach, grasp, retrieve, and release (GR3)" a plastic jar for 40 trials per session, with the assistance of ReIn-hand to open their paretic hand. ReIn-Hand: ReIn-Hand assists the hand opening |
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| Secondary | Upper Extremity Fugl-Meyer Assessment Score | The Fugl-Meyer Assessment (FMA) of Motor Recovery after stroke evaluates and measures motor impairment in post-stroke hemiplegic patients. Different movements are judged on the individuals ability to perform with full capacity, limited capacity, or total inability to complete the required movements. We will use the upper extremity part of FMA, with scores ranging from 0-66, 0 and 66 representing no and normal residual upper extremity motor function, respectively. Higher scores indicate a better outcome. The results are from the measure collected 1 time immediately after conclusion of the intervention (within 1 week). | Posted | Mean | Standard Deviation | points | Within 1 week after conclusion of intervention |
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| Secondary | Chedoke McMaster Stroke Assessment (CMSA) Hand Subscale | This test evaluates the stage of motor recovery for the paretic hand following a stroke. Scores range from 0-7, with 0 representing no function and 7 representing full function of the hand. Higher scores mean better outcome. | Posted | Mean | Standard Deviation | points | Within 1 week after conclusion of intervention |
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| Secondary | Action Research Arm Test (ARAT) | The ARAT test is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). ARAT is a validated quick assessment of the paretic arm's functional disabilities, which offers uncomplicated and comprehensive feedback on the function of their arm, hand and fingers. Scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance. | Posted | Mean | Standard Deviation | points | Within 1 week after conclusion of intervention |
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| Secondary | Kinaesthesia Subscale of Nottingham Sensory Assessment | The kinaesthesia subscale measures an individual's ability to sense movement, direction of movement, and position sense at a given joint. The assessment involves the tester initiating passive movement in the individuals affected finger, wrist, elbow, and shoulder; while the individual attempts to match those movement with their opposite extremity. The total score for this subscale (Kinaesthesia) ranges from 0 to 12. Higher scores indicates better outcome. | Posted | Mean | Standard Deviation | points | Within 1 week after conclusion of intervention |
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| Secondary | Cutaneous Sensory Touch Threshold Using Semmes-Weinstein Monofilaments | The monofilament test is a threshold assay used to determine the minimum stimulation or force that can be felt by a subject. This test is also known as light touch/protective touch/deep pressure testing in the hands. There are 6 monofilament sizes used to test, with each having a corresponding target force in grams. They are as follows, with the target force in grams in parentheses: 2.83 (0.07) - Normal 3.61 (0.4) - Diminished Light Touch 4.31 (2) - Diminished Protective Sensation 4.56 (4) - Loss of Protective Sensation 5.07 (10) - Loss of Protective Sensation 6.65 (300) - Deep Pressure Sensation only For any participant who was unable to sense above 6.65, we applied the score of 7.00 in the analysis. 6 parts of the hand were tested. These 6 values were then averaged to calculate the total hand score. The minimum score for the test is 2.83 and the maximum score is 7.00. Lower scores indicate a better outcome. | Posted | Mean | Standard Deviation | points | Within 1 week after conclusion of intervention |
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| Secondary | Motor Activity Log (MAL) | The Motor Activity Log is a semi-structured interview to assess arm function. Individuals are asked to rate Quality of Movement (QoM) and Amount of Use (AoU) during 30 daily functional tasks, which include object manipulation as well as the use of the affected arm during gross motor activities. Items scored on a 6-point ordinal scale. For the AoU scale, 0 indicates weaker arm was not used at all for activity (never) and 6 indicates ability to use the weaker arm for that activity was as good as before the stroke (normal). For the QoM scale, 0 indicates the weaker arm was not used at all for that activity (never) and 6 indicates that the ability to use the weaker arm for that activity was as good as before the stroke (normal) Higher scores indicate that current function most closely matches unimpaired function prior to the stroke event. | Posted | Mean | Standard Deviation | units on a scale | Within 1 week after conclusion of intervention |
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| Secondary | Stroke Impact Scale (SIS) Stroke Recovery Question | The Stroke Impact Scale (SIS) Stroke Recovery Question is one item that asks the participant to rate on a scale from 0-100 (with 0 meaning no recovery and 100 meaning full recovery) how much they feel they have recovered from their stroke. Higher scores correspond to better outcomes (closer to full recovery following a stroke). | Posted | Mean | Standard Deviation | points | Within 1 week after conclusion of intervention |
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| Secondary | Stereognosis Subscale of Nottingham Sensory Assessment | Stereognosis refers to the ability to identify or perceive the material quality of objects through touch alone, in the absence of visual or auditory stimuli. The individual will be asked to use their paretic hand to identify a number of everyday items through touch alone. Scores of this subscale range from 0-22, with 22 indicating full stereognosis function and 0 representing complete absence of stereognosis. Higher scores indicate better outcomes. | Posted | Mean | Standard Deviation | points | Within 1 week after conclusion of intervention |
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| Secondary | Quantitative Measure of Hand Closing Force (QMHC) | Individual is instructed to lay their affected arm on the table or pillow (depending on participant comfort level). A hand dynamometer is then placed in the affected hand and participant is instructed to close their fist as tight as they can. The dynamometer records grip strength and measures from 0-200 lbs. The test is then repeated with the unaffected arm and hand. Higher numbers correspond to better outcomes (grip strength is close to or is at same level as before stroke). | Posted | Mean | Standard Deviation | pounds | Within 1 week after conclusion of intervention |
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| Secondary | Fractional Anisotropy (FA) of Bilateral Cortico-fugal Tracts | Fractional anisotropy (FA) is a unitless scalar (range: 0-1) derived from diffusion tensor imaging (DTI) that reflects the degree of directional water diffusion within white matter. It is calculated as a normalized ratio of diffusion along principal versus non-principal directions. Higher FA values indicate greater microstructural organization and integrity of the corticospinal tract (CST), whereas lower values suggest reduced integrity. FA was measured in both lesioned (affected by stroke) and non-lesioned CSTs, identified using a seed mask at the posterior limb of the internal capsule (PLIC). | Data was not collected on all participants due to participant limitations. | Posted | Mean | Standard Deviation | Ratio | Within 1 week after conclusion of intervention |
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| Secondary | Hand Pentagon Area (HPA) While Opening With or Without Lifting | This metric quantifies the areas formed by the thumb and fingertips during maximally opening the paretic hand with or without lifting. Hand pentagon area (HPA) is a measure of hand opening ability, collected with Ascension TrakStar motion monitoring equipment. Sensors were placed on each fingertip, palm, wrist, and forearm. The participant was then asked to open their hands as wide as they can. The area (in mm2) was calculated as the sum of the surface area of three triangles formed by the participant's fingertip sensor locations in 3D space: thumb-index-middle, thumb-middle-ring, and thumb-ring-pinky. The maximum HPA presented during each Hand Opening trial was calculated. Higher values correspond to better outcomes (more finger extension/hand opening achievable). | Data was not able to be collected for all participants due to time limitations on the participant side. | Posted | Mean | Standard Deviation | mm^2 | Within 1 week after conclusion of intervention |
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| Secondary | Global Rating of Change (GROC) | The Global Rating of Change is an outcome measure that is used to evaluate improvements in a patient's condition (in this case, their arm function), following an intervention. It has only one item, and is scored on a 15-point self-report scale, with -7 indicating symptoms are a very great deal worse, 0 indicating that no improvement or worsening has been noted, and 7 indicating symptoms are a very great deal better. Negative values indicate worsening symptoms and positive values indicate improving symptoms. | Posted | Mean | Standard Deviation | points | Within 1 week after conclusion of intervention |
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| 0 |
| 25 |
| 0 |
| 25 |
| 1 |
| 25 |
| EG001 | ReIn-Hand | The participant will practice "reach, grasp, retrieve, and release (GR3)" a plastic jar for 40 trials per session, with the assistance of ReIn-hand to open their paretic hand. ReIn-Hand: ReIn-Hand assists the hand opening | 0 | 28 | 0 | 28 | 0 | 28 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013672 |
| Technology |
| D013676 | Technology, Industry, and Agriculture |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Unknown or Not Reported |
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| Hand Opening while Lifting |
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