Trial Outcomes & Findings for Development of a FES Device for Hand Use During Arm Activities Following Stroke (NCT NCT03986216)

Last Updated: 2024-03-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

3 participants

Primary outcome timeframe

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.

Results posted on

2024-03-07

Participant Flow

DEV14 on 5/17/2019 DEV43 on 12/17/2019 DEV201 on 7/22/2020

No significant events.

Participant milestones

Participant milestones
Measure	Home Based Group This group will involve 2-4 randomly selected participants who have already completed the lab based sessions. They will use the developed ReIn-Hand device to assist them to practice 'reach-grasp-retrieve-release' movements at home, 1 hours per day (20 trials), 7 days per week for 12 weeks. ReIn-Hand device assisted home-based practice: Practice reach-grasp-retrieve-release at home with the aid of ReIn-hand device
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Home Based Group n=3 Participants This group will involve 2-4 randomly selected participants who have already completed the lab based sessions. They will use the developed ReIn-Hand device to assist them to practice 'reach-grasp-retrieve-release' movements at home, 1 hours per day (20 trials), 7 days per week for 12 weeks. ReIn-Hand device assisted home-based practice: Practice reach-grasp-retrieve-release at home with the aid of ReIn-hand device
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	58.33 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized White/non-hispanic	2 Participants n=5 Participants
Race/Ethnicity, Customized African American/non-hispanic	1 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants
Box and Blocks	13.74 blocks n=5 Participants
Action Research Arm Test (ARAT)	29.6 scores on a scale n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Home Based Group n=3 Participants This group will involve 2-4 randomly selected participants who have already completed the lab based sessions. They will use the developed ReIn-Hand device to assist them to practice 'reach-grasp-retrieve-release' movements at home, 1 hours per day (20 trials), 7 days per week for 12 weeks. ReIn-Hand device assisted home-based practice: Practice reach-grasp-retrieve-release at home with the aid of ReIn-hand device
Box and Blocks Test (BBT) Score Across the 12 Weeks of the Intervention, Immediately After Conclusion of Intervention, and 3 Months Post-intervention baseline	13.74 blocks Interval 6.0 to 19.5
Box and Blocks Test (BBT) Score Across the 12 Weeks of the Intervention, Immediately After Conclusion of Intervention, and 3 Months Post-intervention post-intervention	21 blocks Interval 14.0 to 27.0
Box and Blocks Test (BBT) Score Across the 12 Weeks of the Intervention, Immediately After Conclusion of Intervention, and 3 Months Post-intervention 3m follow-up	19.67 blocks Interval 17.0 to 24.0

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Home Based Group n=3 Participants This group will involve 2-4 randomly selected participants who have already completed the lab based sessions. They will use the developed ReIn-Hand device to assist them to practice 'reach-grasp-retrieve-release' movements at home, 1 hours per day (20 trials), 7 days per week for 12 weeks. ReIn-Hand device assisted home-based practice: Practice reach-grasp-retrieve-release at home with the aid of ReIn-hand device
Upper Extremity Fugl-Meyer Assessment Motor (FMA) Score baseline	31.83 scores on a scale Interval 29.0 to 35.0
Upper Extremity Fugl-Meyer Assessment Motor (FMA) Score post-intervention	38 scores on a scale Interval 38.0 to 38.0
Upper Extremity Fugl-Meyer Assessment Motor (FMA) Score 3m follow-up	36.33 scores on a scale Interval 30.0 to 40.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Home Based Group n=3 Participants This group will involve 2-4 randomly selected participants who have already completed the lab based sessions. They will use the developed ReIn-Hand device to assist them to practice 'reach-grasp-retrieve-release' movements at home, 1 hours per day (20 trials), 7 days per week for 12 weeks. ReIn-Hand device assisted home-based practice: Practice reach-grasp-retrieve-release at home with the aid of ReIn-hand device
Sensory Assessment (Stereognosis) Baseline	13.83 scores on a scale Interval 2.5 to 21.5
Sensory Assessment (Stereognosis) Post-intervention	12.5 scores on a scale Interval 3.0 to 22.0
Sensory Assessment (Stereognosis) 3m follow-up	15.33 scores on a scale Interval 3.0 to 22.0

SECONDARY outcome

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).

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.

Outcome measures

Outcome measures
Measure	Home Based Group n=3 Participants This group will involve 2-4 randomly selected participants who have already completed the lab based sessions. They will use the developed ReIn-Hand device to assist them to practice 'reach-grasp-retrieve-release' movements at home, 1 hours per day (20 trials), 7 days per week for 12 weeks. ReIn-Hand device assisted home-based practice: Practice reach-grasp-retrieve-release at home with the aid of ReIn-hand device
Cutaneous Sensory Touch Threshold Using Semmes-Weinstein Monofilaments Baseline	4.17 Scores on a scale Interval 3.42 to 5.62
Cutaneous Sensory Touch Threshold Using Semmes-Weinstein Monofilaments Post-Intervention	3.72 Scores on a scale Interval 3.09 to 4.34
Cutaneous Sensory Touch Threshold Using Semmes-Weinstein Monofilaments 3m follow-up	4.24 Scores on a scale Interval 3.35 to 5.88

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Outcome measures
Measure	Home Based Group n=3 Participants This group will involve 2-4 randomly selected participants who have already completed the lab based sessions. They will use the developed ReIn-Hand device to assist them to practice 'reach-grasp-retrieve-release' movements at home, 1 hours per day (20 trials), 7 days per week for 12 weeks. ReIn-Hand device assisted home-based practice: Practice reach-grasp-retrieve-release at home with the aid of ReIn-hand device
Stroke Impact Scale (SIS) baseline	21.83 scores on a scale Interval 15.5 to 27.5
Stroke Impact Scale (SIS) post-intervention	25 scores on a scale Interval 23.0 to 27.0
Stroke Impact Scale (SIS) 3 month follow-up	21 scores on a scale Interval 16.0 to 26.0

SECONDARY outcome

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).

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.

Outcome measures

Outcome measures
Measure	Home Based Group n=3 Participants This group will involve 2-4 randomly selected participants who have already completed the lab based sessions. They will use the developed ReIn-Hand device to assist them to practice 'reach-grasp-retrieve-release' movements at home, 1 hours per day (20 trials), 7 days per week for 12 weeks. ReIn-Hand device assisted home-based practice: Practice reach-grasp-retrieve-release at home with the aid of ReIn-hand device
Action Research Arm Test (ARAT) Baseline	29.6 scores on a scale Interval 22.3 to 37.5
Action Research Arm Test (ARAT) Post-intervention	50 scores on a scale Interval 43.0 to 57.0
Action Research Arm Test (ARAT) 3m follow-up	43 scores on a scale Interval 31.0 to 57.0

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Home Based Group n=3 Participants This group will involve 2-4 randomly selected participants who have already completed the lab based sessions. They will use the developed ReIn-Hand device to assist them to practice 'reach-grasp-retrieve-release' movements at home, 1 hours per day (20 trials), 7 days per week for 12 weeks. ReIn-Hand device assisted home-based practice: Practice reach-grasp-retrieve-release at home with the aid of ReIn-hand device
Chedoke McMaster Stroke Assessment (CMSA) Hand Subscale 3 month follow-up	4 scores on a scale Interval 4.0 to 4.0
Chedoke McMaster Stroke Assessment (CMSA) Hand Subscale Baseline	3.5 scores on a scale Interval 3.0 to 4.0
Chedoke McMaster Stroke Assessment (CMSA) Hand Subscale post-intervention	4.5 scores on a scale Interval 4.0 to 5.0

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Home Based Group n=3 Participants This group will involve 2-4 randomly selected participants who have already completed the lab based sessions. They will use the developed ReIn-Hand device to assist them to practice 'reach-grasp-retrieve-release' movements at home, 1 hours per day (20 trials), 7 days per week for 12 weeks. ReIn-Hand device assisted home-based practice: Practice reach-grasp-retrieve-release at home with the aid of ReIn-hand device
Revised Nottingham Sensory Assessment: Kinaesthesia Subscale baseline	7.17 scores on a scale Interval 4.0 to 9.5
Revised Nottingham Sensory Assessment: Kinaesthesia Subscale post-intervention	8.5 scores on a scale Interval 5.0 to 12.0
Revised Nottingham Sensory Assessment: Kinaesthesia Subscale 3 month follow-up	7.6 scores on a scale Interval 5.0 to 10.0

Adverse Events

Home Based Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jun Yao

Northwestern University

Phone: 3129089060

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place