Trial Outcomes & Findings for Effects of Device-assisted Practice of ADL on Arm/Hand Recovery in Individuals With Moderate to Severe Stroke (NCT NCT04077073)

Due to time limitations for each session, not every subject's data was measured.

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).

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).

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.

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.

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.

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.

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.

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).

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.

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).

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).

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).

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.