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

Completed · Not applicable

Conditions studied: Stroke, Hand Function

In brief

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.

Key facts

Study ID

NCT03986216

Run by

Northwestern University

People needed

3

Starts

2019-05-17

Expected to finish

2021-03-18

Last updated by the study team

2024-03-07

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Northwestern University, Dept. of PTHMS — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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