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

NCT03986216 | Completed Results DMC FDA Device

• 1 other identifier: STU00072008
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Hand Function

Keywords

Stroke rehabilitation; Hand opening; Functional electrical stimulation; Home-based intervention; Task-specific practice; Device-assisted practice

Outcome Measures

Primary Outcomes (1)

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

  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.

Secondary Outcomes (8)

• Upper Extremity Fugl-Meyer Assessment Motor (FMA) Score

  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).

• Quantitative Measure of Hand Opening Area and Closing Force

  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

• Sensory Assessment (Stereognosis)

  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).

• Cutaneous Sensory Touch Threshold Using Semmes-Weinstein Monofilaments

  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.

• Stroke Impact Scale (SIS)

  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).

Study Arms (1)

Home based group

EXPERIMENTAL

This group will involve 2-4 randomly selected participants who have already completed the lab based sessions. They will use the developed reliable and intuitive control of the paretic hand device (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.

Device: ReIn-Hand device assisted home-based practice

Interventions

ReIn-Hand device assisted home-based practice DEVICE

Practice reach-grasp-retrieve-release at home with the aid of ReIn-hand device

Home based group

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 (UEFMA) in the range of 10-40/66, Chedoke McMaster Stroke Assessment Hand (CMSA\_H) stage of the hand section \<=4)
• Normal Cognitive ability (MOCA score \>=24)
• Capacity to provide informed consent
• Ability to elevate their limb against gravity up to at least 75 degrees of shoulder flexion and then 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
• Discharged from all forms of physical rehabilitation
• Intact skin on the hemiparetic arm

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, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Traumatic Brain Injury, peripheral neuropathy)
• 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
• Seizure
• Severe upper extremity sensory impairment indicated by absent sharp-blunt discrimination on the tactile sensation subscale of the Revised Nottingham Sensory Assessment( the score \>=1 on anterior and posterior forearm)
• Chemo denervation: botulinum toxin 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 30 degrees in the elbow, wrist, metacarpophalangeal joints (MCP) and interphalangeal joints (IP)
• Pregnant or planning to become pregnant
• Upper extremity musculoskeletal impairment limiting function prior to stroke.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University, Dept. of PTHMS

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Limitations of the study: 1. This is a small size clinical trial, only 3 participants were recruited. 2. Due to the COVID-19 pandemic, deviations from the protocol were necessary to ensure safety. For one subject, post-intervention data could not be collected and for another, the 3 month follow-up data could not be collected. 3. For one secondary outcome measure, technical problems with measurement were encountered leading to unreliable or uninterpretable data.

Results Point of Contact

• Title: Dr. Jun Yao
• Organization: Northwestern University

j-yao4@northwestern.edu

3129089060

Study Officials

• Jun Yao, PhD

  Department of Physical Therapy and Human Movement Sciences, Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a small clinical trial to determine the feasibility of the product for the purpose of home-based arm/hand practice. We will recruit 2-4 stroke participants to participate the small clinical trial (i.e., the home based practice).

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: June 14, 2019
• Study Start: May 17, 2019
• Primary Completion: March 18, 2021
• Study Completion: March 18, 2021
• Last Updated: March 7, 2024
• Results First Posted: March 7, 2024

Record last verified: 2023-08

Locations

US (1)