NCT04077073

Effects of Device-assisted Practice of ADL on Arm/Hand Recovery in Individuals With Moderate to Severe Stroke

Completed NA Results posted Last updated 14 April 2026

What this trial tests

NA trial testing ReIn-Hand in Stroke in 53 participants. Completed in 16 December 2024.

Timeline

23 September 2019

Primary endpoint
16 December 2024

16 December 2024

Quick facts

Lead sponsor	Northwestern University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	53
Start date	23 September 2019
Primary completion	16 December 2024
Estimated completion	16 December 2024
Sites	2 locations across United States

Drugs / interventions tested

• ReIn-Hand
• Robot

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

Northwestern University

Who can join

Adults 21 to 80, any sex, with Stroke. 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) Primary · Within 1 week after conclusion of intervention

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

Group	Value	95% CI
ReIn-hand and Robot	5.7	± 9.4
ReIn-Hand	8.8	± 9.2

Upper Extremity Fugl-Meyer Assessment Score Secondary · Within 1 week after conclusion of intervention

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 inter

Group	Value	95% CI
ReIn-hand and Robot	23.0	± 8.6
ReIn-Hand	24.3	± 8.6

Chedoke McMaster Stroke Assessment (CMSA) Hand Subscale Secondary · Within 1 week after conclusion of intervention

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.

Group	Value	95% CI
ReIn-hand and Robot	3.4	± 0.8
ReIn-Hand	3.4	± 0.8

Action Research Arm Test (ARAT) Secondary · Within 1 week after conclusion of intervention

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.

Group	Value	95% CI
ReIn-hand and Robot	13.8	± 11.7
ReIn-Hand	17.6	± 13.1

Kinaesthesia Subscale of Nottingham Sensory Assessment Secondary · Within 1 week after conclusion of intervention

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.

Group	Value	95% CI
ReIn-hand and Robot	8.42	± 2.26
ReIn-Hand	9.72	± 5.98

Cutaneous Sensory Touch Threshold Using Semmes-Weinstein Monofilaments Secondary · Within 1 week after conclusion of intervention

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 Sensa

Affected Side

Group	Value	95% CI
ReIn-hand and Robot	4.51	± 1.32
ReIn-Hand	4.59	± 1.32

Unaffected Side

Group	Value	95% CI
ReIn-hand and Robot	3.39	± 0.29
ReIn-Hand	3.57	± 0.38

Motor Activity Log (MAL) Secondary · Within 1 week after conclusion of intervention

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 tha

Amount Scale

Group	Value	95% CI
ReIn-hand and Robot	0.84	± 0.80
ReIn-Hand	0.94	± 0.79

How Well Scale

Group	Value	95% CI
ReIn-hand and Robot	0.86	± 0.66
ReIn-Hand	1.02	± 0.74

Stroke Impact Scale (SIS) Stroke Recovery Question Secondary · Within 1 week after conclusion of intervention

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).

Group	Value	95% CI
ReIn-hand and Robot	61	± 21
ReIn-Hand	62	± 18

Stereognosis Subscale of Nottingham Sensory Assessment Secondary · Within 1 week after conclusion of intervention

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.

Group	Value	95% CI
ReIn-hand and Robot	12.1	± 7.7
ReIn-Hand	14.5	± 6.9

Quantitative Measure of Hand Closing Force (QMHC) Secondary · Within 1 week after conclusion of intervention

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).

Unaffected Hand Closing Force

Group	Value	95% CI
ReIn-hand and Robot	69.86	± 27.97
ReIn-Hand	77.02	± 18.93

Affected Hand Closing Force

Group	Value	95% CI
ReIn-hand and Robot	18.06	± 17.45
ReIn-Hand	22.61	± 12.69

Fractional Anisotropy (FA) of Bilateral Cortico-fugal Tracts Secondary · Within 1 week after conclusion of intervention

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)

Non-lesioned CST

Group	Value	95% CI
ReIn-hand and Robot	0.4140	± 0.0147
ReIn-Hand	0.4181	± 0.0257

Lesioned CST

Group	Value	95% CI
ReIn-hand and Robot	0.3700	± 0.0636
ReIn-Hand	0.3677	± 0.0974

Hand Pentagon Area (HPA) While Opening With or Without Lifting Secondary · Within 1 week after conclusion of intervention

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-ri

Hand Opening without Lifting

Group	Value	95% CI
ReIn-hand and Robot	21.66	± 7.55
ReIn-Hand	19.42	± 10.35

Hand Opening while Lifting

Group	Value	95% CI
ReIn-hand and Robot	19.43	± 7.26
ReIn-Hand	15.77	± 10.38

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected from enrollment through study completion, an average of six months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ReIn-hand and Robot

Serious: 0/25 (0%)

Deaths: 0/25

ReIn-Hand

Serious: 0/28 (0%)

Deaths: 0/28

Other adverse events (1 terms — click to expand)

Reaction	System	ReIn-hand and Robot	ReIn-Hand
EFF122 arm pain	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT04077073 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications 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
2. 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.
   Drogos JM, Carmona C, Arceo R, Yao J. · · 2025 · PMID 40616111 · DOI 10.1186/s13063-025-08930-7
3. 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
   Drogos J, Carmona C, Yao J, Arceo R. · · 2025 · DOI 10.21203/rs.3.rs-5010507/v1