NCT05180812

Brief Summary

The purpose of this study is to evaluate the safety, feasibility, and preliminary efficacy of the ExoNET passive robotic device. It will provide upper-extremity gravity compensation for therapeutic movement retraining in the chronic post stroke patient population.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable stroke

Timeline
2mo left

Started Mar 2022

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Mar 2022Jul 2026

First Submitted

Initial submission to the registry

December 5, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2023

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2026

Expected
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

1.4 years

First QC Date

December 5, 2021

Last Update Submit

April 7, 2025

Conditions

StrokeCerebral Vascular Accident

Keywords

Upper ExtremityRehabilitationStroke

Outcome Measures

Primary Outcomes (1)

  • Action Research Arm Test

    observational measure used to assess change in upper extremity performance in individuals with a damaged nervous system

    Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations)

Secondary Outcomes (3)

  • Fugl-Meyer

    Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations)

  • Wolf Motor Function Test

    Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations)

  • Box and Blocks

    Tested at week 1 (baseline evaluations), week 4 (post evaluations), and week 9 (follow-up evaluations)

Other Outcomes (2)

  • Electromyography using Delsys

    Treatment phases (week 2 and week 3)

  • Kinect

    Treatment phases (week 2 and week 3)

Study Arms (2)

Experimental Group: Gravity Compensation

EXPERIMENTAL

The participants will be wearing the ExoNet device tuned to gravity support.

Device: ExoNet Tuned to Gravity Support

Control Group: No Gravity Compensation

SHAM COMPARATOR

The participants will be wearing the ExoNet device, but it will not be tuned to gravity support.

Device: ExoNet Tuned to Gravity Support

Interventions

ExoNet Tuned to Gravity SupportDEVICE

This study's primary goal is to test the safety, feasibility, and efficacy of the ExoNET device developed in the Robotics Lab at the Shirley Ryan AbilityLab. We want to observe if individuals using the ExoNET tuned to gravity support will notice a reduction in bicep muscle activity, leading to an improvement in functional outcome measures in stroke patients.

Control Group: No Gravity CompensationExperimental Group: Gravity Compensation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ischemic or hemorrhagic stroke (8 months post stroke)
  • Available medical records and radiographic information about lesion locations
  • Hemiparesis
  • Some degree of both shoulder and elbow movement capability
  • A "moderate" impairment (Fugl-Meyer score between 15-50)

You may not qualify if:

  • Individuals under the age of 18
  • Bilateral paresis
  • Shoulder pain and/or articular rigidity on the upper limb joint
  • Spasticity (Modified Ashworth Scale of 2)
  • Botox injection to the affected upper extremity within the previous 4 months
  • Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to perform the experiment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60610, United States

Location

Related Publications (1)

  • Celian C, Ryali P, Wilson V, Srivatsa A, Patton JL. A Wearable Anti-Gravity Supplement to Therapy Does Not Improve Arm Function in Chronic Stroke: A Randomized Pilot Trial. Neurorehabil Neural Repair. 2025 Sep;39(9):728-741. doi: 10.1177/15459683251338792. Epub 2025 Jun 19.

    PMID: 40537460DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Director, Robotics Laboratory, Arms and Hands Lab, Shirley Ryan AbilityLab

Study Record Dates

First Submitted

December 5, 2021

First Posted

January 6, 2022

Study Start

March 1, 2022

Primary Completion

July 12, 2023

Study Completion (Estimated)

July 12, 2026

Last Updated

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)