Stroke Clinical Trial
— SRT5Official title:
Neurophysiological and Kinematic Predictors of Response in Chronic Stroke
Verified date | February 2022 |
Source | VA Pittsburgh Healthcare System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 1 |
Est. completion date | March 31, 2020 |
Est. primary completion date | March 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Clinically defined, unilateral, hemiparetic stroke with radiologic exclusion of other possible diagnosis - 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 Exclusion Criteria: - 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 - Participants with electromagnetic exclusions (metal implants in the cranium, implanted electronic devices etc.) will not be precluded from the study but will be excluded from the MRI and TMS portions - Have a serious complicating medical illness that would preclude participation |
Country | Name | City | State |
---|---|---|---|
United States | VA Pittsburgh Healthcare System | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
VA Pittsburgh Healthcare System | University of Pittsburgh |
United States,
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jiménez 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. Review. Erratum in: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196. — View Citation
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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
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:CD006876. doi: 10.1002/14651858.CD006876.pub5. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | A Change in Motor Evoked Potential During Transcranial Magnetic Stimulation of the Motor Cortex | TMS stimulation of the motor cortex will be performed using MagStim 200 Magnetic Stimulators (MagStim Ltd., Wales, UK) to assess change in the motor evoked potential (MEP) of the arm muscles. | Immediately following the 12-week intervention | |
Other | A Change in Brain Connections Assessed Via MRI of the Brain | A detailed analysis of the MRI data will examine individual interregional connections to determine whether any of them are more sensitive to the intervention than others. | Immediately following the 12-week intervention | |
Primary | 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 |
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