N/A
N=3
Development of a FES Device for Hand Use During Arm Activities Following Stroke
Stroke · Hand Function
Bottom Line
View on ClinicalTrials.gov: NCT03986216 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Box and Blocks Test (BBT) Score Across the 12 Weeks of the Intervention, Immediately After Conclusion of Intervention, and 3 Months Post-intervention — 13.74; 21; 19.67 blocks
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ReIn-Hand device assisted home-based practice (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Box and Blocks Test (BBT) Score Across the 12 Weeks of the Intervention, Immediately After Conclusion of Intervention, and 3 Months Post-intervention |
13.74; 21; 19.67 | — |
| SECONDARY Upper Extremity Fugl-Meyer Assessment Motor (FMA) Score |
31.83; 38; 36.33 | — |
| SECONDARY Quantitative Measure of Hand Opening Area and Closing Force |
— | — |
| SECONDARY Sensory Assessment (Stereognosis) |
13.83; 12.5; 15.33 | — |
| SECONDARY Cutaneous Sensory Touch Threshold Using Semmes-Weinstein Monofilaments |
4.17; 3.72; 4.24 | — |
| SECONDARY Stroke Impact Scale (SIS) |
21.83; 25; 21 | — |
| SECONDARY Action Research Arm Test (ARAT) |
29.6; 50; 43 | — |
| SECONDARY Chedoke McMaster Stroke Assessment (CMSA) Hand Subscale |
3.5; 4.5; 4 | — |
| SECONDARY Revised Nottingham Sensory Assessment: Kinaesthesia Subscale |
7.17; 8.5; 7.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 =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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03986216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.