NCT05180786

Brief Summary

This study is being done to see how errors lead to improvement. Specifically, we are evaluating the errors stroke participants make during an upper extremity exercise program when reaching for a target using their affected arm. Once we understand the participant's reaching errors, we plan to create a customized reaching exercise according to the individual's specific error tendencies which will lead to better performance on movement ability after training.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable stroke

Geographic Reach
1 country

3 active sites

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

November 4, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

October 24, 2024

Status Verified

September 1, 2024

Enrollment Period

2.8 years

First QC Date

November 4, 2021

Last Update Submit

October 22, 2024

Conditions

StrokeCerebral Vascular Accident (CVA)/Stroke

Keywords

Upper ExtremityRehabilitationArmRoboticsStroke

Outcome Measures

Primary Outcomes (1)

  • Perpendicular Error

    60-90 minutes

Secondary Outcomes (1)

  • Action Research Arm Test

    5-20 minutes

Other Outcomes (2)

  • Upper Extremity portion of the Fugl-Meyer

    5-20 minutes

  • Box and Blocks

    5-20 minutes

Study Arms (2)

Group 1

OTHER
Other: Error FieldsOther: No Error Fields

Group 2

OTHER
Other: Error FieldsOther: No Error Fields

Interventions

Error FieldsOTHER

Participants will complete a reaching experiment using the robotic arm with error fields turned on.

Group 1Group 2
No Error FieldsOTHER

Participants will complete a reaching experiment using the robotic arm with error fields turned off.

Group 1Group 2

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • Chronic stroke (8+ months post stroke event) with primary motor cortex involvement
  • Hemiparesis
  • Some degree of both shoulder and elbow movement capability

You may not qualify if:

  • Bilateral paresis
  • Severe tactile deficits using the Two-Point Discrimination Test (participant must detect\<11mm)
  • Severe proprioceptive deficits
  • Severe spasticity (Modified Ashworth \>3) preventing movement
  • Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to perform the experiment
  • Visual deficits, and hemispatial neglect that would prevent the subjects from seeing the targets.
  • Inability to provide an informed consent
  • severe current medical problems
  • diffuse/multiple lesion sites or multiple stroke events
  • Inability to attain and maintain testing positions
  • Botox injection to the affected upper extremity within the previous 4 months
  • Concurrent participation in upper extremity rehabilitation either as part of a research intervention protocol or a prescribed therapy
  • Participation in previous, similar robotics intervention study
  • Other neurological issues
  • None of the following special populations will be included in this research study:
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Shirley Ryan AbilityLab (Healthy Participants)

Chicago, Illinois, 60611, United States

RECRUITING

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • James Patton, PhD

    Shirley Ryan AbilityLab

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Courtney Celian

CONTACT

3122381560ccelian@sralab.org

Naveed Aghamohammadi

CONTACT

7654215544nagham2@uic.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, 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

November 4, 2021

First Posted

January 6, 2022

Study Start

March 1, 2023

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

October 24, 2024

Record last verified: 2024-09

Locations

US(3)