NCT06655636

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

March 25, 2024

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 23, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

December 4, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

12 months

First QC Date

March 25, 2024

Last Update Submit

January 7, 2025

Conditions

StrokeCerebral Vascular Accident

Keywords

Upper ExtremityRehabilitationStroke

Outcome Measures

Primary Outcomes (1)

  • Action Research Arm Test (ARAT)

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

    Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation)

Secondary Outcomes (2)

  • Upper extremity portion of the Fugl-Meyer (FMUE)

    Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation)

  • Box and Blocks

    Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation)

Other Outcomes (2)

  • Electromyography using Delsys

    Treatment phases (week 1, week 2 and week 3)

  • Joint Kinematics using Microsoft Kinect

    Treatment phases (week 1, week 2 and week 3)

Study Arms (2)

Group 1 - Assistance, Sham, Anti-Assistance

EXPERIMENTAL

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.

Device: Device tuned to AssistanceDevice: Device tuned to Sham (Slack Springs)Device: Device tuned to Anti-Assistance

Group 2 - Sham, Assistance, Anti-Assistance

EXPERIMENTAL

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.

Device: Device tuned to AssistanceDevice: Device tuned to Sham (Slack Springs)Device: Device tuned to Anti-Assistance

Interventions

Device tuned to AssistanceDEVICE

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

Group 1 - Assistance, Sham, Anti-AssistanceGroup 2 - Sham, Assistance, Anti-Assistance
Device tuned to Sham (Slack Springs)DEVICE

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.

Group 1 - Assistance, Sham, Anti-AssistanceGroup 2 - Sham, Assistance, Anti-Assistance
Device tuned to Anti-AssistanceDEVICE

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

Group 1 - Assistance, Sham, Anti-AssistanceGroup 2 - Sham, Assistance, Anti-Assistance

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 40-70 (to reduce confounding effects of aging on muscle, movement accuracy and proprioception)
  • Have sustained a single, unilateral stroke at least 8 months prior to enrollment
  • Severe to moderate upper extremity impairment (ARAT score 0-30)
  • Ability to move their elbow and wrist when supported against gravity
  • Cortical stroke with hemiparesis, tactile sensation
  • Available medical records about lesion locations indicating the stroke was caused by a middle cerebral artery ischemic infarct

You may not qualify if:

  • Bilateral paresis
  • Diffuse/multiple lesion sites or multiple stroke events
  • Hemispatial neglect or visual field cut that prevent visual feedback
  • Shoulder pain and/or articular rigidity on the upper limb joint
  • Severe sensory deficits indicated by the Two-Point Discrimination Test
  • Botox injection to the affected upper extremity within the previous 4 months
  • Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to consent, perform the experiment, or follow commands
  • Concurrent participation in upper extremity rehabilitation either as part of a research intervention protocol or a prescribed therapy
  • Other neurological issues
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60610, United States

RECRUITING

Related Publications (4)

  • Lannin NA, Cusick A, Hills C, Kinnear B, Vogel K, Matthews K, Bowring G. Upper limb motor training using a Saebo orthosis is feasible for increasing task-specific practice in hospital after stroke. Aust Occup Ther J. 2016 Dec;63(6):364-372. doi: 10.1111/1440-1630.12330. Epub 2016 Sep 19.

    PMID: 27646624BACKGROUND

  • Gijbels D, Lamers I, Kerkhofs L, Alders G, Knippenberg E, Feys P. The Armeo Spring as training tool to improve upper limb functionality in multiple sclerosis: a pilot study. J Neuroeng Rehabil. 2011 Jan 24;8:5. doi: 10.1186/1743-0003-8-5.

    PMID: 21261965BACKGROUND

  • J. S. Sulzer, M. A. Peshkin and J. L. Patton, "MARIONET: An exotendon-driven rotary series elastic actuator for exerting joint torque," 9th International Conference on Rehabilitation Robotics, 2005. ICORR 2005., Chicago, IL, USA, 2005, pp. 103-108, doi: 10.1109/ICORR.2005.1501062.

    BACKGROUND

  • Ryali, P., Carella, T., McDermed, D., Perizes, V., Huang, F., & Patton, J. (2020). A Theoretical Framework for a Network of Elastic Elements Generating Arbitrary Torque Fields. In 2020 8th IEEE RAS/EMBS International Conference for Biomedical Robotics and Biomechatronics (BioRob) (pp. 286-291). IEEE.

    BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Valentino I Wilson

CONTACT

630-398-2355viwilso2@uic.edu

Courtney Celian, MSOT

CONTACT

312-238-1560ccelian@sralab.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
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

March 25, 2024

First Posted

October 23, 2024

Study Start

December 4, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 9, 2025

Record last verified: 2025-01

Locations

US(1)