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

NCT04077073 | Completed Results DMC FDA Device

• 2 other identifiers: STU00206913R01HD095187
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stroke

Keywords

stroke rehabilitation; hand opening; flexion synergy; robot assisted treatment; functional electrical stimulation; motor recovery; brain plasticity

Outcome Measures

Primary Outcomes (1)

• Box and Blocks Test (BBT)

  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).

  Within 1 week after conclusion of intervention

Secondary Outcomes (12)

• Upper Extremity Fugl-Meyer Assessment Score

  Within 1 week after conclusion of intervention

• Chedoke McMaster Stroke Assessment (CMSA) Hand Subscale

  Within 1 week after conclusion of intervention

• Action Research Arm Test (ARAT)

  Within 1 week after conclusion of intervention

• Kinaesthesia Subscale of Nottingham Sensory Assessment

  Within 1 week after conclusion of intervention

• Cutaneous Sensory Touch Threshold Using Semmes-Weinstein Monofilaments

  Within 1 week after conclusion of intervention

Study Arms (2)

ReIn-hand and robot

EXPERIMENTAL

The participant will practice "reach, grasp, retrieve, and release (GR3)" a plastic jar for 40 trials per session, with the assistance of ReIn-hand to open their paretic hand and of robot to reduce the shoulder load.

Device: ReIn-Hand; Device: Robot

ReIn-Hand

ACTIVE COMPARATOR

The participant will practice "reach, grasp, retrieve, and release (GR3)" a plastic jar for 40 trials per session, with the assistance of ReIn-hand to open their paretic hand.

Device: ReIn-Hand

Interventions

ReIn-Hand DEVICE

ReIn-Hand assists the hand opening

Also known as: ReIn-Hand assisted

ReIn-Hand; ReIn-hand and robot

Robot DEVICE

Robot supports the shoulder load

Also known as: Robot support

ReIn-hand and robot

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 21-80
• Paresis confined to one side, with substantial motor impairment of the upper limb and some residual voluntary movement (Upper Extremity Fugl-Meyer Assessment score in the range of 10-40/66, Chedoke McMaster Stroke Assessment - Stage of the hand section score \<=4)
• Capacity to provide informed consent
• Ability to elevate their limb against gravity up to at least 75 degrees of shoulder flexion and to generate some active elbow extension
• Ability to open hand with a thumb-to-index finger distance ≥4 cm, with the assistance of the ReIn-Hand device with the help of a physical therapist
• MRI compatible
• Discharged from all forms of physical rehabilitation
• Intact skin on the hemiparetic arm
• Be tolerate sitting for no less than 1 hour
• Montreal Cognitive Assessment (MoCA) score \>=23

You may not qualify if:

• Motor or sensory impairment in the non-affected limb
• Any brainstem and/or cerebellar lesion
• Severe concurrent medical problems (e.g. cardiorespiratory impairment, uncontrolled hypertension, inflammatory joint disease)
• History of neurologic disorder other than stroke (Parkinson's Disease, Acute Lateral Sclerosis, Multiple Sclerosis, Traumatic Brain Injury, peripheral neuropathy, Amyotrophic lateral sclerosis, spinal cord injury, Dementia)
• Any acute or chronic painful condition in the upper extremities or spine, indicated by a score ≥5 on a 10-point visual analog scale
• Using cardiac pacemaker, implanted cardioverter defibrillator, neurostimulation system inside the brain or spinal cord, bone growth box fusion stimulation
• Seizure in the last 6 months
• Severe upper extremity sensory impairment indicated by absent sensation on the tactile sensation subscale (light touch and pressure items) of the Revised Nottingham Assessment of Somato-Sensations (score\<4)
• Chemo denervation: botulinum toxin, dysport, or Myobloc or phenol block injection to any portion of the paretic UE within the last 6 months, or phenol/alcohol injections \<12 months before participation
• Unable to passively attain 90 degrees of shoulder flexion and abduction, measured using a goniometer based on adapted methods
• Flexion contractures larger than 45 degrees in the elbow, wrist, metacarpophalangeal joints (MCP) and interphalangeal joints (IP) of thumb and index finger
• Pregnant or planning to become pregnant
• Participating in any experimental rehabilitation or drug studies
• Inability to attend intervention sessions 3 times a week during 8 weeks, as well as to assessments/evaluations and follow up
• Upper extremity musculoskeletal impairment limiting function prior to stroke

Sponsors & Collaborators

• Northwestern University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

645 N Michigan Ave, Suite 1100

Chicago, Illinois, 60611, United States

Location

Northwestern University, Dept. of PTHMS

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• Drogos JM, Carmona C, Arceo R, Yao J. 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. Trials. 2025 Jul 4;26(1):238. doi: 10.1186/s13063-025-08930-7.

  PMID: 40616111 DERIVED

• Carmona C, Sullivan JE, Arceo R, Drogos J, Besser S, Gutierrez S, Jeteric Z, Wyman J, Yao J. Development and Preliminary Validity Study of a Modified Version of the Upper Extremity Fugl-Meyer Assessment for Use in Telerehabilitation. J Neurol Phys Ther. 2023 Oct 1;47(4):208-216. doi: 10.1097/NPT.0000000000000447. Epub 2023 Jun 14.

  PMID: 37314323 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Jun Yao, PhD
• Organization: Northwestern University

j-yao4@northwestern.edu

312-908-9060

Study Officials

• Jun Yao, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 4, 2019
• Study Start: September 23, 2019
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: May 4, 2026
• Results First Posted: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)