NCT04283253

Brief Summary

This study will validate a predictive model that uses demographics, functional status, neurophysiology, neuroanatomy, and other potential biomarkers to predict the likelihood of a clinically significant change in impairment at the end of a robot assisted therapy intervention.The study will include magnetic resonance imaging (MRI), transcranial magnetic stimulation (TMS), and an arm exercise program consisting of robot-assisted exercise combined with functional arm exercise called transition to task training (TTT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Oct 2019

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

October 22, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

March 3, 2022

Completed
Last Updated

March 3, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

January 21, 2020

Results QC Date

December 6, 2021

Last Update Submit

March 1, 2022

Conditions

StrokeBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • A Change in the Fugl-Meyer Upper Extremity Assessment Score

    The Fugl-Meyer is one of the primary outcome measures assessing change in arm use from baseline testing to mid-training after visits 12 and 24, and post-training after visit 36 and the 12 week retention period. It is a stroke-specific measure of impairment of the upper extremity that has been shown to be valid and reliable with high inter-rater and test-retest reliability. It provides a direct-observational assessment of volitional movement and motor impairment related to reflexes, sensation, and abnormal synergies. Each item on the FM is rated on a three-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). The scale ranges from 0-66 with higher scores representing less motor impairment.

    Immediately following the 12-week intervention

Other Outcomes (2)

  • A Change in Motor Evoked Potential During Transcranial Magnetic Stimulation of the Motor Cortex

    Immediately following the 12-week intervention

  • A Change in Brain Connections Assessed Via MRI of the Brain

    Immediately following the 12-week intervention

Study Arms (1)

Robot + TTT Exercise

EXPERIMENTAL

All participants will be enrolled in this group to receive the same 60 minute study intervention consisting of wrist and shoulder-elbow robot training and TTT arm exercises.

Device: Robot + TTT exercise

Interventions

Robot + TTT exerciseDEVICE

The intervention will be completed 36 visits approximately 3x/week for 12-18 weeks. The training progression will be sequential with 12 visits completed on the wrist robot, followed by 12 visits on the shoulder-elbow robot and completing with 12 visits alternating sessions on the wrist and shoulder-elbow robot. Participants will perform robot training for 45 minutes with each robot followed by 15 minutes of TTT practice to complete their 60 minute intervention session.

Robot + TTT Exercise

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stroke onset at least 6 months before enrollment
  • Present with Mild/Moderate to Severe arm dysfunction (based on Fugl-Meyer scores of 10 to 45)
  • Be medically stable to participate in the study
  • Be English speaking

You may not qualify if:

  • Unable to give informed consent
  • Have a serious complicating medical illness that would preclude participation.
  • Contractures or orthopedic problems limiting range of joint motion in the potential study arm
  • Visual loss such that the subject would not be able to see the test patterns on the robot computer monitor
  • Botulinum toxin to study arm within four months of study enrollment or if received during the study period
  • Unable to comply with requirements of the study
  • Participants with a history of a seizure will not be precluded from the study, but will not be enrolled in the TMS portions
  • Have a serious complicating medical illness that would preclude participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (6)

  • Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available. Erratum In: Circulation. 2017 Mar 7;135(10):e646. doi: 10.1161/CIR.0000000000000491. Circulation. 2017 Sep 5;136(10):e196. doi: 10.1161/CIR.0000000000000530.

    PMID: 28122885BACKGROUND

  • Mehrholz J, Pohl M, Platz T, Kugler J, Elsner B. Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2018 Sep 3;9(9):CD006876. doi: 10.1002/14651858.CD006876.pub5.

    PMID: 30175845BACKGROUND

  • Stinear CM, Byblow WD, Ackerley SJ, Barber PA, Smith MC. Predicting Recovery Potential for Individual Stroke Patients Increases Rehabilitation Efficiency. Stroke. 2017 Apr;48(4):1011-1019. doi: 10.1161/STROKEAHA.116.015790. Epub 2017 Mar 9.

    PMID: 28280137BACKGROUND

  • Connell LA, Smith MC, Byblow WD, Stinear CM. Implementing biomarkers to predict motor recovery after stroke. NeuroRehabilitation. 2018;43(1):41-50. doi: 10.3233/NRE-172395.

    PMID: 30056436BACKGROUND

  • Lang CE, Bland MD, Bailey RR, Schaefer SY, Birkenmeier RL. Assessment of upper extremity impairment, function, and activity after stroke: foundations for clinical decision making. J Hand Ther. 2013 Apr-Jun;26(2):104-14;quiz 115. doi: 10.1016/j.jht.2012.06.005. Epub 2012 Sep 10.

    PMID: 22975740BACKGROUND

  • Gauthier LV, Taub E, Mark VW, Perkins C, Uswatte G. Improvement after constraint-induced movement therapy is independent of infarct location in chronic stroke patients. Stroke. 2009 Jul;40(7):2468-72. doi: 10.1161/STROKEAHA.109.548347. Epub 2009 May 21.

    PMID: 19461024BACKGROUND

MeSH Terms

Conditions

StrokeBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCardiovascular Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersVascular Diseases

Results Point of Contact

Title
George Wittenberg
Organization
UNIVERSITY OF PITTSBURGH
GEOWITT@PITT.EDU
4126484178

Study Officials

  • George Wittenberg, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: One-arm, multiple baseline sequential, cohort study
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2020

First Posted

February 25, 2020

Study Start

October 22, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

March 3, 2022

Results First Posted

March 3, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

A de-identified, anonymized dataset will be created and shared. Where practicable, sharing should take place under a written agreement prohibiting the recipient from identifying or re-identifying (or taking steps to identify or reidentify) any individual whose data are included in the dataset. However, it is permissible for final datasets in machine-readable format to be submitted to and accessed from PubMed Central (and similar sites) provided that care is taken to ensure that the individuals cannot be re-identified using other publicly available information. Datasets will be made available to the public following appropriate approvals for disclosure criteria. Every effort will be made to protect personal privacy and the confidentiality of private information collected for research purposes. This particular dataset will be de-identified and the minimum amount of information necessary to achieve the objectives of the research proposed will be collected and shared.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US(1)