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הניסוי הקליני NCT07189819 עבור Post-stroke Hemiparesis הוא טרם החל גיוס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן.
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חזרה לחיפוש

Innovative Closed-loop Functional Electrical Stimulation Control System for Augmenting Post-stroke Gait 20 טיפול חדשני

טרם החל גיוס
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT07189819 הוא מחקר מסוג התערבותי עבור Post-stroke Hemiparesis, שנמצא במצב טרם החל גיוס. גיוס המשתתפים צפוי להתחיל ב-1 ביוני 2026, במטרה לכלול 20 משתתפים. המחקר ינוהל על ידי אוניברסיטת אמורי וצפוי להסתיים ב-1 בדצמבר 2026. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-25 במרץ 2026.
סיכום קצר
This study will compare the performance of a novel data-driven model-predictive controller (MPC) based functional electrical stimulation (FES) system versus a conventional FES system for footdrop correction during treadmill and overground walking tasks in people post-stroke.
תיאור מפורט
Functional electrical stimulation (FES) is a common rehabilitation tool that incorporates electrical stimulation timed with a functional task to augment paretic muscle function in people with neuro-pathologies such as stroke and spinal cord injury. The rigor of previous research has established the safety, as well as both neuro-prosthetic and therapeutic effects of FES systems for standing, walking, and grasping. Str...הצג עוד
כותרת רשמית

Innovative Closed-loop Functional Electrical Stimulation Control System for Augmenting Post-stroke Gait

מצבים רפואיים
Post-stroke Hemiparesis
מזהי מחקר נוספים
מספר NCT
NCT07189819
תחילת המחקר (בפועל)
2026-06-01
עדכון אחרון שפורסם
2026-03-25
סיום המחקר (מוערך)
2026-12-01
משתתפים (מתוכנן)
20
סוג המחקר
התערבותי
שלב
לא ישים
סטטוס
טרם החל גיוס
מילות מפתח
post-stroke gait
מטרה ראשית
טיפול
הקצאת טיפול
אקראי
דגם מתערב
מחקר מוצלב
עיוורון
אין (מחקר פתוח)
זרועות / התערבויות
קבוצת משתתפים/זרועהתערבות/טיפול
ניסיMPC FES Followed by Conventional FES
Post-stroke participants participating in both treadmill and overground walking trials with the novel model-predictive controller (MPC) functional electrical stimulation (FES) system first and with a conventional functional electrical stimulation (FES) system second.
Model-Predictive Controller (MPC) Functional Electrical Stimulation (FES)
The model-predictive controller (MPC) determines the timing and intensity of electrical stimulation delivered for FES. MPC combined with real-time ultrasound-based feedback delivers optimal FES intensities and minimizes fatigue. FES is delivered to the ankle dorsiflexor muscles using a commercially available FDA-approved electrical stimulator.
Conventional Functional Electrical Stimulation (FES)
For functional electrical stimulation, surface electrodes are placed on the paretic leg on skin overlying the tibialis anterior (TA) muscle, with intensity pre-set to elicit dorsiflexion to neutral against gravity. FES will be delivered to the ankle dorsiflexor muscles using a commercially available FDA-approved electrical stimulator.
ניסיConventional FES Followed by MPC FES
Post-stroke participants participating in both treadmill and overground walking trials with a conventional functional electrical stimulation (FES) system first and the novel model-predictive controller (MPC) functional electrical stimulation (FES) system second.
Model-Predictive Controller (MPC) Functional Electrical Stimulation (FES)
The model-predictive controller (MPC) determines the timing and intensity of electrical stimulation delivered for FES. MPC combined with real-time ultrasound-based feedback delivers optimal FES intensities and minimizes fatigue. FES is delivered to the ankle dorsiflexor muscles using a commercially available FDA-approved electrical stimulator.
Conventional Functional Electrical Stimulation (FES)
For functional electrical stimulation, surface electrodes are placed on the paretic leg on skin overlying the tibialis anterior (TA) muscle, with intensity pre-set to elicit dorsiflexion to neutral against gravity. FES will be delivered to the ankle dorsiflexor muscles using a commercially available FDA-approved electrical stimulator.
מדדי תוצאה ראשיים
מדד תוצאהתיאור המדידהטווח זמן
Number of Adverse Events
Safety is assessed as the number of adverse events experienced by study participants.
Day 1
Count of Risks
Safety is assessed as the count of risks, including falling, discomfort, pain, skin problems, fatigue, and soreness.
Day 1
Participant Perception of Comfort
Participant perception of comfort is measured on an 10-point Likert scale ranging from 1 to 10, where 10 is the most comfortable.
Day 1
Participant Perception of Acceptability
Participant perception of acceptability is measured on an 10-point Likert scale ranging from 1 to 10, where 10 is the most acceptable.
Day 1
Percent of Gait Cycles with Footdrop Correction
Feasibility of the FES control system is assessed as the percentage of gait cycles with footdrop correction. The FES control system is considered effective if greater than 80% of gait cycles have footdrop correction.
Day 1
Number of Participants Completing Gait Bouts
Feasibility of the FES control system is assessed as the number of participants who are able to complete gait bouts with the MPC FES system. The FES control system is considered effective if greater than 80% of participants are able to complete gait bouts.
Day 1
מדדי תוצאה משניים
מדד תוצאהתיאור המדידהטווח זמן
Peak Ankle Dorsiflexion Angle During Swing
Gait biomechanics performance is assessed as the peak ankle dorsiflexion angle during swing. The normal range for peak ankle dorsiflexion is 0 to 5 degrees.
Day 1
Overground Walking Distance
Gait performance is assessed as overground walking distance traveled, in meters, during a 6-minute walk test.
Day 1
FES Intensity
FES system performance is assessed as FES intensity. FES intensity is measured during a treadmill walking bout. Intensity is measured by milliamps (mA) or millivolts (mV).
Day 1
עוזר השתתפות
קריטריוני זכאות

גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
40 Years
מגדרים מוערכים למחקר
הכל
  • >6 months since stroke
  • cortical or subcortical stroke
  • able to walk 10-meters with or without an assistive device
  • sufficient cardiovascular health and ankle stability to walk on treadmill without ankle orthosis
  • passive ankle range of motion to benefit from dorsiflexor FES assistance
  • resting heart rate 40-100 bpm

  • cerebellar signs
  • score >1 on question 1b (does not know the current month and age) and >0 on question 1c (can not blink eyes and squeeze hands) on NIH Stroke Scale
  • inability to communicate with investigators
  • neglect/hemianopia
  • unexplained dizziness in past 6 months
  • sensory loss in paretic leg
  • musculoskeletal or medical conditions limiting walking
  • neurologic diagnoses other than stroke
Emory University logoאוניברסיטת אמורי
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) logoEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
הגורם האחראי למחקר
Trisha Kesar, חוקר ראשי, Associate Professor, Emory University
איש קשר מרכזי למחקר
איש קשר: Trisha Kesar, PT, PhD, (404) 712-5803, [email protected]
1 מיקומי המחקר ב-1 מדינות

Georgia

Emory Rehabilitation Hospital, Atlanta, Georgia, 30322, United States