NCT05345301

Brief Summary

The purpose of this study is to measure how cortical signals improve in stroke participants after passive hand stretching therapy from a robotic glove.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 28, 2022

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2022

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

April 19, 2022

Last Update Submit

July 25, 2023

Conditions

Stroke

Keywords

Upper ExtremityBody Computer Interface

Outcome Measures

Primary Outcomes (1)

  • Rate of activation of Event Related Desynchronization

    Sensorimotor neural activity

    1 hour

Study Arms (1)

Measuring neural activity

EXPERIMENTAL

While completing hand opening/closing, individuals will have the following measured (1) Neural activity (specifically sensorimotor rhythms) using a EEG cap; (2) muscle activity (specifically finger flexors and extensors) using EMG sensors.

Diagnostic Test: Event related desynchronization measurement

Interventions

Event related desynchronization measurementDIAGNOSTIC_TEST

Individuals will spend one hour and receive cues to open or close their hand while wearing a EEG cap and EMG sensors on their forearm.

Measuring neural activity

Eligibility Criteria

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

You may qualify if:

  • Ischemic or hemorrhagic stroke (6 months post stroke)
  • Hemiparesis
  • Some degree of hand and finger movement capability
  • a moderate impairment (Fugl-Meyer score between 15-50)

You may not qualify if:

  • Individuals under the age of 18
  • Bilateral paresis
  • Hand pain and/or extreme articular contractures on the finger joints (Modified Ashworth Scale of 4)
  • 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, 60611, United States

Location

Related Publications (12)

  • Ang KK, Guan C, Chua KS, Phua KS, Wang C, Chin ZY, Zhou L, Tang KY, Joseph GJ, Kuah C. A clinical study of motor imagery BCI performance in stroke by including calibration data from passive movement. Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:6603-6. doi: 10.1109/EMBC.2013.6611069.

    PMID: 24111256RESULT

  • Buch E, Weber C, Cohen LG, Braun C, Dimyan MA, Ard T, Mellinger J, Caria A, Soekadar S, Fourkas A, Birbaumer N. Think to move: a neuromagnetic brain-computer interface (BCI) system for chronic stroke. Stroke. 2008 Mar;39(3):910-7. doi: 10.1161/STROKEAHA.107.505313. Epub 2008 Feb 7.

    PMID: 18258825RESULT

  • Dobkin B, Barbeau H, Deforge D, Ditunno J, Elashoff R, Apple D, Basso M, Behrman A, Harkema S, Saulino M, Scott M; Spinal Cord Injury Locomotor Trial Group. The evolution of walking-related outcomes over the first 12 weeks of rehabilitation for incomplete traumatic spinal cord injury: the multicenter randomized Spinal Cord Injury Locomotor Trial. Neurorehabil Neural Repair. 2007 Jan-Feb;21(1):25-35. doi: 10.1177/1545968306295556.

    PMID: 17172551RESULT

  • Peles O, Werner-Reiss U, Bergman H, Israel Z, Vaadia E. Phase-Specific Microstimulation Differentially Modulates Beta Oscillations and Affects Behavior. Cell Rep. 2020 Feb 25;30(8):2555-2566.e3. doi: 10.1016/j.celrep.2020.02.005.

    PMID: 32101735RESULT

  • Triandafilou KM, Kamper DG. Carryover effects of cyclical stretching of the digits on hand function in stroke survivors. Arch Phys Med Rehabil. 2014 Aug;95(8):1571-6. doi: 10.1016/j.apmr.2014.04.008. Epub 2014 May 2.

    PMID: 24794423RESULT

  • Thielbar KO, Triandafilou KM, Fischer HC, O'Toole JM, Corrigan ML, Ochoa JM, Stoykov ME, Kamper DG. Benefits of Using a Voice and EMG-Driven Actuated Glove to Support Occupational Therapy for Stroke Survivors. IEEE Trans Neural Syst Rehabil Eng. 2017 Mar;25(3):297-305. doi: 10.1109/TNSRE.2016.2569070. Epub 2016 May 17.

    PMID: 27214905RESULT

  • McFarland DJ, Sarnacki WA, Wolpaw JR. Effects of training pre-movement sensorimotor rhythms on behavioral performance. J Neural Eng. 2015 Dec;12(6):066021. doi: 10.1088/1741-2560/12/6/066021. Epub 2015 Nov 3.

    PMID: 26529119RESULT

  • Ramos-Murguialday A, Broetz D, Rea M, Laer L, Yilmaz O, Brasil FL, Liberati G, Curado MR, Garcia-Cossio E, Vyziotis A, Cho W, Agostini M, Soares E, Soekadar S, Caria A, Cohen LG, Birbaumer N. Brain-machine interface in chronic stroke rehabilitation: a controlled study. Ann Neurol. 2013 Jul;74(1):100-8. doi: 10.1002/ana.23879. Epub 2013 Aug 7.

    PMID: 23494615RESULT

  • Seo NJ, Rymer WZ, Kamper DG. Delays in grip initiation and termination in persons with stroke: effects of arm support and active muscle stretch exercise. J Neurophysiol. 2009 Jun;101(6):3108-15. doi: 10.1152/jn.91108.2008. Epub 2009 Apr 8.

    PMID: 19357330RESULT

  • Yuan H, He B. Brain-computer interfaces using sensorimotor rhythms: current state and future perspectives. IEEE Trans Biomed Eng. 2014 May;61(5):1425-35. doi: 10.1109/TBME.2014.2312397.

    PMID: 24759276RESULT

  • Prasad G, Herman P, Coyle D, McDonough S, Crosbie J. Applying a brain-computer interface to support motor imagery practice in people with stroke for upper limb recovery: a feasibility study. J Neuroeng Rehabil. 2010 Dec 14;7:60. doi: 10.1186/1743-0003-7-60.

    PMID: 21156054RESULT

  • Morone NE, Greco CM, Moore CG, Rollman BL, Lane B, Morrow LA, Glynn NW, Weiner DK. A Mind-Body Program for Older Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Intern Med. 2016 Mar;176(3):329-37. doi: 10.1001/jamainternmed.2015.8033.

    PMID: 26903081RESULT

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
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Robotics Laboratory, Arms and Hands Lab

Study Record Dates

First Submitted

April 19, 2022

First Posted

April 25, 2022

Study Start

March 28, 2022

Primary Completion

September 14, 2022

Study Completion

September 14, 2022

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

US(1)