بيتا
رادار التجارب AI
حالة التجربة السريرية NCT06752707 لـ السكتة الدماغية تحت الحادة هي قيد التجنيد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا.
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
العودة إلى البحث

MiGo Tracker Remote Monitoring of Home Exercise After Stroke

قيد التجنيد
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ 'رادار التجارب AI' أن يساعدك؛ ما عليك سوى النقر على 'وصف الدراسة' لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT06752707 هي دراسة تدخُّلية لـالسكتة الدماغية تحت الحادة وهي قيد التجنيد. بدأت في ١٥ ذو الحجة ١٤٤٦ هـ مع خطة لتجنيد ٥٠ مشاركًا. يقودها Flint Rehabilitation Devices, LLC، ومن المتوقع اكتمالها بحلول ١٨ ربيع الأول ١٤٤٨ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٢١ محرم ١٤٤٧ هـ.
الملخص
This project will determine the safety and effectiveness of a MiGo Tracker RTM program in a randomized controlled trial with individuals with subacute stroke (N=50). Participants will be randomly assigned to either the MiGo Tracker RTM program (intervention group) or prescription of home exercises with no monitoring (usual care/control group). All participants will still receive usual post-stroke care, including outpatient rehabilitation. The main question this study aims to answer is: Does a MiGo Tracker RTM program lead to significantly greater motor recovery at three-months post stroke than the usual care group. If successful, MiGo Tracker will lead to increased home exercise adherence and improved health outcomes for thousands of individuals following stroke.
العنوان الرسمي

MiGo Tracker: Seamless Remote Therapeutic Monitoring of Exercise Adherence After Stroke

الحالات الطبية
السكتة الدماغية تحت الحادة
معرّفات دراسة أخرى
NCT معرّف
NCT06752707
تاريخ البدء (فعلي)
2025-06-11
آخر تحديث مُنشور
2025-07-16
تاريخ الاكتمال (المقدر)
2026-08-31
عدد المشاركين المخطط لهم
٥٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
قيد التجنيد
الكلمات الرئيسية
Remote Therapeutic Monitoring
Stroke
Home Exercise Therapy
MiGo Tracker
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
أحادي
مجموعات/التدخلات
مجموعة المشاركين/مجموعةتَدَخُّل/علاج
تجريبيةMiGo Tracker enabled RTM Program
Participants will be provided a MiGo Tracker device which will log all home exercise sessions and uploaded to the MiGo-RTM dashboard. The supervising study therapist will conduct weekly phone calls with each participant where they review exercise metrics and assist with any barriers or issues.
Migo Tracker
Perform home exercise sessions while wearing MiGo Tracker device that logs exercise data.
مقارن نشطConventional Standard of Care
Participants will be assigned a home exercise regimen designed by a study therapist based on the individual participant's specific goals and abilities.
Conventional Home Exercise Program
Exercise following printed sheets or booklet
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
Change in Upper Extremity Fugl-Meyer from Baseline
The Fugl-Meyer Assessment - Upper Extremity (FMA-UE) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, sensation, balance, joint range of motion and joint pain in patients with post-stroke hemiplegia. A standardized assessment of arm impairment based on scores of 0-2 on 33 different tasks. Minimum value = 0, maximum value = 66, higher scores = better outcome
Baseline and 3 months post stroke
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
Change in Action Research Arm Test from Baseline
The Action Research Arm Test (ARAT) is a 19-item measure aimed at assessing functional performance of the upper extremity through observational means. The ARAT is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: (3) Performs test normally (2) Completes test, but takes abnormally long or has great difficulty (1) Performs test partially (0) Can perform no part of test
Baseline and 3 months post stroke
Change in Box and Blocks from Baseline
The Box and Block Test assesses unilateral gross manual dexterity. The test is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period.
Baseline and 3 months post stroke
Change in Motor Activity Log from Baseline
The MAL is a semi-structured interview to assess arm function. Individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during 30 daily functional tasks. Items scored on a 6-point ordinal scale. Scoring on Amount of Use Scale: 0) The weaker arm was not sued at all for that activity (never) 1) very rarely 2) rarely 3) half pre-stroke 4)3/4 pre-stroke 5) normal. Quality of Movement Scale: 0) The weaker arm was not used at all for that activity (never) 1) very poor 2) poor 3) fair 4) almost normal 5) normal
Baseline and 3 months post stroke
Change in Modified Ashworth Spasticity Scale from Baseline
MAS is an assessment that is used to measure the increase in muscle tone. MAS assigns a grade of spasticity from a 0-4 ordinal scale. The grade is assigned by moving a joint/muscle through a high velocity quick stretch. A score of 1 indicates no resistance, and 5 indicates rigidity.
Baseline and 3 months post stroke
Change in Visual Analog Pain Scale from Baseline
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10cm line that represents a continuum between "no pain" and "worst pain".
Baseline and 3 months post stroke
معايير الأهلية

الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
  • Experienced one or more strokes less than one month (30 days) prior
  • Upper Extremity Fugl-Meyer Score > 5 and <= 55 out of 66
  • Absence of moderate to severe pain (<= 4 on the 10 point visual-analog pain scale)

  • age <18 years old
  • Unable to follow 2-step commands
  • Other neurological diagnosis (e.g. Parkinson's Disease)
  • Other severe concurrent medical conditions that may prevent the participants from completing the 3-month study
Flint Rehabilitation Devices, LLC logoFlint Rehabilitation Devices, LLC
  • National Institute on Aging (NIA) logoNational Institute on Aging (NIA)
  • Rancho Research Institute, Inc. logoRancho Research Institute, Inc.
جهة اتصال مركزية للدراسة
جهة اتصال: Ian M Russell, PhD, 3392232676, [email protected]
جهة اتصال: Daniel Zondervan, PhD, 949-313-7322, [email protected]
1 مواقع الدراسة في 1 بلدان

California

Rancho Research Institute, Inc, Downey, California, 90242, United States
Nicole Bayus, جهة اتصال, 562-385-7049, [email protected]
Susan Shaw, MD, المحقق الرئيسي
قيد التجنيد