Actively Recruiting

Phase Not Applicable
Age: 40Years - 70Years
All Genders
Healthy Volunteers
ID06655636

Safety and Feasibility of Exoskeletal Network Device for Forearm Supination Assistance in Stroke Survivors Assisting Stroke Survivors With Engineering Technology (ASSET): ExoNET for Forearm Supination

Led by Shirley Ryan AbilityLab · Updated on 2025-01-09

30

Participants Needed

1

Research Sites

51 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, feasibility, and effectiveness of a passive robotic device called the forearm ExoNET, designed to assist forearm supination in adults who have survived a stroke. This device uses a network of springs to provide gentle support and has the potential to improve motor learning and rehabilitation for individuals with neurological impairments. The study focuses on adults aged 40 to 70 who have moderate to severe upper arm impairment due to a single stroke occurring at least eight months prior. The study involves testing three configurations of the ExoNET device: one tuned to assist forearm supination, one set as a sham with slack springs providing no real force, and one tuned to resist forearm supination. Participants will wear the device during daily upper extremity tasks that require forearm supination. The device's effects will be monitored using wearable sensors that measure muscle activity and arm movements. Participants will be assessed at baseline and during follow-up sessions using the Action Research Arm Test (ARAT) to measure arm function. Researchers will also monitor muscle activity and range of motion with electromyography and motion sensors. Safety, feasibility, and patient tolerance of the device will be observed throughout the study, which involves several testing visits over a few weeks.

CONDITIONS

Official Title

Safety and Feasibility of an ExoNET for Supination Assistance for Stroke Survivors

Who Can Participate

Age: 40Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Between the ages of 40 and 70 to reduce effects of aging on muscle and movement
  • Have had a single, one-sided stroke at least 8 months before joining
  • Moderate to severe upper arm impairment with an ARAT score from 0 to 30
  • Ability to move elbow and wrist when supported against gravity
  • Stroke caused by a middle cerebral artery ischemic infarct with hemiparesis and tactile sensation
  • Available medical records confirming lesion locations
Not Eligible

You will not qualify if you...

  • Bilateral weakness on both sides
  • Multiple stroke events or multiple lesion sites
  • Visual problems preventing visual feedback such as hemispatial neglect or visual field cuts
  • Shoulder pain or joint stiffness in the upper limb
  • Severe sensory loss shown by Two-Point Discrimination Test
  • Botox injection in affected arm within last 4 months
  • Aphasia, cognitive or emotional problems affecting consent or task performance
  • Currently participating in other upper limb rehabilitation therapies
  • Other neurological disorders
  • Contraindications for Delsys Trigno Sensors including implanted electronic devices, irritated skin or open wounds, and silver allergy

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Shirley Ryan AbilityLab

Chicago, Illinois, United States, 60610

Actively Recruiting

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Research Team

V

Valentino I Wilson

C

Courtney Celian, MSOT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Upper limb motor training using a Saebo™ orthosis is feasible for increasing task-specific practice in hospital after stroke.

Natasha A Lannin, Anne Cusick, Caroline Hills...

https://pubmed.ncbi.nlm.nih.gov/27646624