Cerebral Vascular Accident, Stroke
Conditions
Keywords
Upper Extremity, Rehabilitation, Stroke
Brief summary
The purpose of this study is to evaluate the safety, feasibility, and efficacy of an exoskeletal network of passive, multi-joint springs for forearm supination. Also known as the forearm ExoNET, the device is a passive, robotic device that will properly assist forearm supination in the post-stroke adult population.
Detailed description
The ExoNET, a passive robotic solution that provides a soft, biomimetic, and elastic alternative to robotics that embodies intelligence within the mechanical design. Several groups have been exploring performance enhancement using springs with custom-tuned parameters via optimization. Here, it is possible to have a simple reconfigurable system that can not only assist performance, but can also make training easier, faster, and more complete. This contribution has the potential to be clinically significant for rehabilitating neurologically impaired individuals because this proposal will investigate how motor learning can be facilitated through novel assistive technology. The primary objective of this study is to evaluate the safety, feasibility, and efficacy of using the forearm ExoNET. Specifically, investigators would like to see if the forearm ExoNET tuned to assistance will lead to a reduction in forearm muscle activity and an increase in active supination range of motion. To accomplish this, we plan to have participants perform upper extremity activities of daily living requiring active forearm supination wearing the ExoNET. To achieve these goals, we will use a wearable surface electromyography (EMG) and inertial measurement unit (IMU) using Delsys wearable sensors on the forearm muscles. Investigators hypothesize that individuals with post-stroke arm movement deficits will experience gains in Action Research Arm Test (ARAT) measures that are significantly above their baseline levels while using the forearm ExoNET tuned to supination assistive support. Secondarily, investigators hypothesize that a forearm ExoNET tuned to supination assistive support will lead to a significant reduction in arm muscle activity and no significant difference in range of motion across a series of upper-extremity tasks in adults without a history of stroke. Lastly, it is hypothesized that usage of a forearm ExoNET tuned to supination anti-assistance can be safe, feasible and tolerated by patients in a given treatment session.
Interventions
DEVICEDevice tuned to Assistance
The device spring components will be tuned to produce an assistive supination torque on the forearm.
DEVICEDevice tuned to Sham (Slack Springs)
The device spring components will be tuned to slack springs to serve as a placebo. The user will think they are receiving forces but in reality the device will not be providing any forces.
DEVICEDevice tuned to Anti-Assistance
The device spring components will be tuned to produce a resistive supination torque on the forearm.
Sponsors
Shirley Ryan AbilityLab
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Between the ages of 40-70 (to reduce confounding effects of aging on muscle, movement accuracy and proprioception) 2. Have sustained a single, unilateral stroke at least 8 months prior to enrollment 3. Severe to moderate upper extremity impairment (ARAT score 0-30) 4. Ability to move their elbow and wrist when supported against gravity 5. Cortical stroke with hemiparesis, tactile sensation 6. Available medical records about lesion locations indicating the stroke was caused by a middle cerebral artery ischemic infarct
Exclusion criteria
1. Bilateral paresis 2. Diffuse/multiple lesion sites or multiple stroke events 3. Hemispatial neglect or visual field cut that prevent visual feedback 4. Shoulder pain and/or articular rigidity on the upper limb joint 5. Severe sensory deficits indicated by the Two-Point Discrimination Test 6. Botox injection to the affected upper extremity within the previous 4 months 7. Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to consent, perform the experiment, or follow commands 8. Concurrent participation in upper extremity rehabilitation either as part of a research intervention protocol or a prescribed therapy 9. Other neurological issues 10. Meet any of the contraindications to Delsys Trigno Sensors: * Implanted with electronic devices of any kind, including cardiac pace-makers or similar assistive devices, electronic induction pumps, and implanted stimulators * Irritated skin or open wounds * Silver allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm Test (ARAT) | Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation) | Observational measure used to assess change in upper extremity performance in individuals with a damaged nervous system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Upper extremity portion of the Fugl-Meyer (FMUE) | Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation) | Observational measure used to measure change in upper extremity impairment in individuals with a damaged nervous system |
| Box and Blocks | Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation) | Measures change in unilateral gross motor dexterity |
Other
| Measure | Time frame | Description |
|---|---|---|
| Electromyography using Delsys | Treatment phases (week 1, week 2 and week 3) | Delsys sensors will be used to measure change in biceps activity |
| Joint Kinematics using Microsoft Kinect | Treatment phases (week 1, week 2 and week 3) | Markerless joint tracking system will be used to collect changes in the joint kinematics to identify changes in limb movement compensatory strategies |
Countries
United States
Contacts
Primary ContactValentino I Wilson
Backup ContactCourtney Celian, MSOT
Outcome results
None listed