Development of a FES Device for Hand Use During Arm Activities Following Stroke

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 compartments 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 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 block. The reported results have decimals since we take the mean of 2 baseline assessments.

Time frame: Assessed at baseline, weekly during intervention, post-intervention (within 1 week after conclusion of intervention), and 3 month follow up (assessed for up to 6 months total); baseline, post-intervention and 3 month follow up (6 months) data reported.

Population: Three right hand dominant participants who have chronic stroke (\>1y) with moderate impairment at left side.

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 (within ten to fifteen minutes) 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. Higher scores indicate better performance. Decimals are included in the lower and upper limits of the Full Range in the baseline row as these resulted from the averaging of two baseline scores.

Time frame: Assessed at baseline, weekly during intervention, post-intervention (within 1 week after conclusion of intervention), and 3 month follow up (assessed for up to 6 months total); baseline, post-intervention and 3 month follow up (6 months) data reported.

Population: Three right hand dominant participants who have chronic stroke (\>1y) with moderate impairment at left side. Action Research Arm Test (ARAT) Data for the post-intervention could not be collected for 1 participant (DEV43).

This test evaluate the stage of motor recovery for the paretic hand. Scores range from 0-7, with 7 representing full function of the hand.

Time frame: Assessed at and data presented and reported for baseline, post-intervention (within 1 week after last intervention), and at a 3 month follow up (assessed for up to 6 months total).

Population: Three right hand dominant participants who have chronic stroke (\>1y) with moderate impairment at left side. Chedoke McMaster Stroke Assessment (CMSA) Hand Subscale Data for the post-intervention could not be collected for 1 participant (DEV43).

The monofilament test is a threshold assay used to determine the minimum 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 6 parts of the hand were tested. These 6 values were then averaged. The minimum score for the test is 2.83 and the maximum score is 6.65. For any participant who was unable to sense above 6.65, we applied the score of 6.65 in the analysis. Lower scores indicate a better outcome.

Time frame: Assessed at baseline, weekly during intervention, post-intervention (within 1 week after conclusion of intervention), and 3 month follow up (assessed for up to 6 months total); baseline, post-intervention and 3 month follow up (6 months) data reported.

Population: Three right hand dominant participants who have chronic stroke (\>1y) with moderate impairment at left side. Cutaneous Sensory Touch Threshold using Semmes-Weinstein Monofilaments Score for the post-intervention could not be collected for 1 participant (DEV43).

Individual will be instructed to rest paretic hand on a cylinder that is covered with an array of pressure sensors (Pressure Profile Systems, Inc., Los Angeles, California 90045). Furthermore, 5 markers (9x9 mm) with unique optical features will be placed on the tip of the thumb and the 4 fingers. Individual will then be instructed to perform following task in their comfortable pace: 1) resting, 2) maximally open the paretic hand, and 3) maximally close the paretic hand against the cylinder. Position (with an accuracy of 1mm) and angular (with an accuracy at 0.02 degree) information of fingertips will be captured by 2 registered portable Moire Phase Tracking cameras (Metria Innovation, Inc., Wauwatosa, WI); and the flexion force under the 4 fingers and thumb will be measured by the pressure sensors. This will allow for tracking of the hand pentagon area and closing force during intervention.

Time frame: This will be measured pre-intervention (within 1 week prior to intervention), 1 time per week during intervention, immediately after conclusion of intervention (within 1 week), and at a 3 month follow up

Population: Data could not be collected safely for 2 subjects due to restrictions from the Coronavirus Disease of 2019 (COVID-19) pandemic. The data collected for the first subject was of poor quality and could not be analyzed.

The kinaesthesia subscale measures an individuals 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. Scores for each joint range from 0-3, with higher scores meaning a better outcome. 0 - Absent - no appreciation of movement taking place 1. \- appreciation of movement taking place 2. \- direction of movement sense 3. \- joint position sense The minimum score is 0 and the maximum score is 12. Decimals are included in the lower and upper limits of the Full Range in the baseline row as these resulted from the averaging of two baseline scores.

Time frame: Assessed at and data presented and reported for baseline, post-intervention (within 1 week after last intervention), and at a 3 month follow up (assessed for up to 6 months total).

Population: Three right hand dominant participants who have chronic stroke (\>1y) with moderate impairment at left side. Revised Nottingham Sensory Assessment: Kinaesthesia Subscale Data for the post-intervention could not be collected for 1 participant (DEV43).

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 range from 0-24, with 24 indicating full stereognosis function and 0 representing complete absence of stereognosis. Decimals are included in the lower and upper limits of the Full Range in the baseline row as these resulted from the averaging of two baseline scores.

Time frame: Assessed at and data presented and reported for baseline, post-intervention (within 1 week after last intervention), and at a 3 month follow up (assessed for up to 6 months total).

Population: Three right hand dominant participants who have chronic stroke (\>1y) with moderate impairment at left side. Sensory Assessment (Stereognosis) Score for the post-intervention could not be collected for 1 participant (DEV43).

The SIS is a 59 item measure of strength, hand function, activities of daily living, mobility, communication, emotion, memory, and participation. Each item is rated in a 5 point scale in terms of difficulty experienced in completing the item, ranging from 1 (could not do it at all) to 5 (not difficult at all). We reported here the total of strength (minimum possible score 4 and maximum possible score 20) and hand portion (minimum possible score 5 and maximum possible score 25). Subscale scores were summed to compute the total score (minimum possible score 9 and maximum possible score 45). Decimals are included in the lower and upper limits of the Full Range in the baseline row as these resulted from the averaging of two baseline scores.

Time frame: Assessed at and data presented and reported for baseline, post-intervention (within 1 week after last intervention), and at a 3 month follow up (assessed for up to 6 months total).

Population: Three right hand dominant participants who have chronic stroke (\>1y) with moderate impairment at left side. Stroke Impact Scale (SIS) Data for the post-intervention could not be collected for 1 participant (DEV43).

The Fugl-Meyer Assessment of Motor Recovery after stroke evaluates and measures recovery in post-stroke hemiplegic patients. It is used in both the clinical and research settings, and is one of the most widely used quantitative measures of motor impairment. Areas of assessment include activities of daily living, functional mobility, and pain. Different movements are judged on the individuals ability to perform with full capacity, limited capacity, or total inability to complete the movement. Scores range from 0-66, with 0 and 66 representing no and normal residual upper extremity motor function, respectively. Higher scores indicate a better outcome.

Time frame: Assessed at and data presented and reported for baseline, post-intervention (within 1 week after last intervention), and at a 3 month follow up (assessed for up to 6 months total).

Population: Three right hand dominant participants who have chronic stroke (\>1y) with moderate impairment at left side. Upper Extremity Fugl-Meyer Assessment Motor (FMA) Score for the post-intervention could not be collected for 1 participant (DEV43).