Recruiting

ExoNET

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT06655636

Conditions

Stroke

Cerebral Vascular Accident

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Accepted

Interventions

Device tuned to Assistance

Device tuned to Sham (Slack Springs)

Device tuned to Anti-Assistance

Study Details

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.

Conditions

Stroke

Cerebral Vascular Accident

Study ID

NCT06655636

Start date

Dec 4, 2024

Status verified date

Jan, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1 - Assistance, Sham, Anti-Assistance

Group 1 receives all three interventions in the order of assistance, then sham (slack springs), then anti-assistance. Each intervention corresponds to different settings on the device.

experimental: Group 2 - Sham, Assistance, Anti-Assistance

Group 2 receives all three interventions in the order of sham (slack springs), then assistance, then anti-assistance. Each intervention corresponds to different settings on the device.

Interventions

Device tuned to Assistance

The device spring components will be tuned to produce an assistive supination torque on the forearm.

Device 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.

Device tuned to Anti-Assistance

The device spring components will be tuned to produce a resistive supination torque on the forearm.

Primary outcome measure

  • Action Research Arm Test (ARAT) [ Time Frame: Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation) ]

Central Contacts and Locations

Central contacts

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60610

Contacts

Courtney Celian, OTR/L

312-238-1560ccelian@sralab.org

Principal Investigator:

James Patton, PhD

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

Jan 9, 2025

Last verified

Jan, 2025

Keywords

  • Upper Extremity
  • Rehabilitation
  • Stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2025-01-09.