NCT03986216

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

Completed NA Results posted Last updated 7 March 2024

What this trial tests

NA trial testing ReIn-Hand device assisted home-based practice in Stroke in 3 participants. Completed in 18 March 2021.

Timeline

17 May 2019

Primary endpoint
18 March 2021

18 March 2021

Quick facts

Lead sponsor	Northwestern University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Enrollment	3
Start date	17 May 2019
Primary completion	18 March 2021
Estimated completion	18 March 2021
Sites	1 location across United States

Drugs / interventions tested

• ReIn-Hand device assisted home-based practice

Conditions studied

• Stroke — all drugs for Stroke →
• Hand Function — all drugs for Hand Function →

Sponsor

Northwestern University

Who can join

Adults 21 to 80, any sex, with Stroke or Hand Function. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Box and Blocks Test (BBT) Score Across the 12 Weeks of the Intervention, Immediately After Conclusion of Intervention, and 3 Months Post-intervention Primary · 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.

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

baseline

Group	Value	95% CI
Home Based Group	13.74	6 – 19.5

post-intervention

Group	Value	95% CI
Home Based Group	21	14 – 27

3m follow-up

Group	Value	95% CI
Home Based Group	19.67	17 – 24

Upper Extremity Fugl-Meyer Assessment Motor (FMA) Score Secondary · 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).

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 functio

baseline

Group	Value	95% CI
Home Based Group	31.83	29 – 35

post-intervention

Group	Value	95% CI
Home Based Group	38	38 – 38

3m follow-up

Group	Value	95% CI
Home Based Group	36.33	30 – 40

Sensory Assessment (Stereognosis) Secondary · 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).

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.

Baseline

Group	Value	95% CI
Home Based Group	13.83	2.5 – 21.5

Post-intervention

Group	Value	95% CI
Home Based Group	12.5	3 – 22

3m follow-up

Group	Value	95% CI
Home Based Group	15.33	3 – 22

Cutaneous Sensory Touch Threshold Using Semmes-Weinstein Monofilaments Secondary · 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.

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 pa

Baseline

Group	Value	95% CI
Home Based Group	4.17	3.42 – 5.62

Post-Intervention

Group	Value	95% CI
Home Based Group	3.72	3.09 – 4.34

3m follow-up

Group	Value	95% CI
Home Based Group	4.24	3.35 – 5.88

Stroke Impact Scale (SIS) Secondary · 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).

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). Dec

baseline

Group	Value	95% CI
Home Based Group	21.83	15.5 – 27.5

post-intervention

Group	Value	95% CI
Home Based Group	25	23 – 27

3 month follow-up

Group	Value	95% CI
Home Based Group	21	16 – 26

Action Research Arm Test (ARAT) Secondary · 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.

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.

Baseline

Group	Value	95% CI
Home Based Group	29.6	22.3 – 37.5

Post-intervention

Group	Value	95% CI
Home Based Group	50	43 – 57

3m follow-up

Group	Value	95% CI
Home Based Group	43	31 – 57

Chedoke McMaster Stroke Assessment (CMSA) Hand Subscale Secondary · 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).

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.

Baseline

Group	Value	95% CI
Home Based Group	3.5	3 – 4

post-intervention

Group	Value	95% CI
Home Based Group	4.5	4 – 5

3 month follow-up

Group	Value	95% CI
Home Based Group	4	4 – 4

Revised Nottingham Sensory Assessment: Kinaesthesia Subscale Secondary · 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).

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 min

baseline

Group	Value	95% CI
Home Based Group	7.17	4 – 9.5

post-intervention

Group	Value	95% CI
Home Based Group	8.5	5 – 12

3 month follow-up

Group	Value	95% CI
Home Based Group	7.6	5 – 10

Sponsor's own description

The goal of the study is to develop an individualized, synergy resistant, portable electromyographic (EMG)-driven functional electrical stimulation (FES) device that allows for Reliable and Intuitive control of hand (ReIn-Hand) opening while using the paretic arm during lifting and reaching. Furthermore, to enable sufficient practice intensity both in the clinic and at home, the investigators propose to develop the ReIn-Hand device with easy-to-use utilities by developing a user-customized forearm/hand orthosis with embedded EMG recording and stimulation electrode. To test the device feasibility, a small clinical trial will be conducted. Information related to the clinical trial will be provided below.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Development and Preliminary Validity Study of a Modified Version of the Upper Extremity Fugl-Meyer Assessment for Use in Telerehabilitation.
   Carmona C, Sullivan JE, Arceo R, Drogos J, et al · · 2023 · cited 7× · PMID 37314323 · DOI 10.1097/npt.0000000000000447