ट्रायल रडार AI | ||
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क्लिनिकल ट्रायल NCT06268041 (HST2) के लिए स्ट्रोक वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
खोज पर वापस जाएँ
सिनसिनाटी विश्वविद्यालयHIT-Stroke Trial 2 (HST2) 156 व्यायाम
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT06268041 (HST2) एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो स्ट्रोक से जुड़ा हुआ है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 9 फ़रवरी 2024 को हुई थी, और इसमें कुल 156 प्रतिभागियों के नामांकन की योजना है। सिनसिनाटी विश्वविद्यालय इस परीक्षण का नेतृत्व कर रहे हैं और इसके 1 अप्रैल 2028 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 9 जनवरी 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
People who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. Measures including walking function will be assessed at baseline (PRE), after 4, 8 and 12 weeks of training (12WK) and at...और दिखाएँ
आधिकारिक शीर्षक
Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover Walking Post-Stroke: HIT-Stroke Trial 2
स्वास्थ्य स्थितियां
स्ट्रोकप्रकाशन
इस नैदानिक परीक्षण के बारे में प्रकाशित वैज्ञानिक लेख और शोध पत्र:अन्य अध्ययन आईडी
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2024-02-09
अंतिम अद्यतन प्रकाशित
2025-01-09
अध्ययन की समाप्ति तिथि (अनुमानित)
2028-04
नामांकन (अनुमानित)
156
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
भर्ती जारी
प्रमुख शब्द
gait
aerobic
locomotion
aerobic
locomotion
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
एकल अंध
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
सक्रिय तुलना समूहModerate-Intensity Aerobic Training | Moderate-Intensity Aerobic Training Overground and treadmill walking with speed continuously adjusted to maintain a target heart rate of 40 +/- 5% heart rate reserve, progressing up to 55 +/- 5% heart rate reserve. |
प्रयोगात्मकHigh-Intensity Interval Training | उच्च-तीव्रता अंतराल प्रशिक्षण Overground and treadmill walking with 30 second bursts at maximum speed alternated with 30-60 second passive recovery periods. Intended to achieve a target average heart rate above 60% heart rate reserve. |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
6-Minute Walk Test Distance | Total distance walked in 6 minutes in meters | Change from Baseline to 12 weeks |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
6-Minute Walk Test Distance | Total distance walked in 6 minutes in meters | Change from Baseline to 3 month follow up |
Self-Selected Gait Speed | From 10-meter walk test at self-selected speed, in meters per second | Change from Baseline to 12 weeks |
Fastest Gait Speed | From 10-meter walk test at fastest speed, in meters per second | Change from Baseline to 12 weeks |
PROMIS-Fatigue Scale version 8a | An 8-item self-report questionnaire about symptoms of fatigue. Each item is rated from 1-5. Items are combined to obtain a total T score, where higher scores indicate greater fatigue. | Change from Baseline to 3 month follow up |
Aerobic Capacity | Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute | Change from Baseline to 12 weeks |
EuroQol-5D-5L | A 6-item questionnaire about quality of life, including: mobility, self-care, usual activities, pain/discomfort, anxiety/depression and overall health. Each item is scored from 1 to 5, where lower scores indicate greater quality of life. A total 'misery score' will be calculated by averaging the scores for each item. | Change from Baseline to 3 month follow up |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
30 Years
अध्ययन के लिए पात्र लिंग
सभी
- Age 30-85 years at time of consenting
- Hemiparesis from ischemic and/or hemorrhagic strokes
- Most recent stroke for which participant sought treatment, at least 6 months prior to study consent
- Walking speed <1.0 m/s on the 10-meter walk test
- Able to walk 10m over ground with assistive devices as needed and no continuous physical assistance from another person (guarding and intermittent assistance for loss of balance allowed)
- Able to walk at least 3 minutes on the treadmill at ≥0.13m/s (0.3 mph)
- Stable cardiovascular condition (AHA class B, allowing for aerobic capacity <6 metabolic equivalents)
- Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions
- Exercise testing uninterpretable for ischemia or arrhythmia (e.g. resting ECG abnormality that makes exercise ECG uninterpretable for ischemia and no other clinical testing from the past year available to rule out these conditions)
- Evidence of significant arrhythmia or myocardial ischemia on treadmill ECG graded exercise test in the absence of recent (past year) more definitive clinical testing (e.g. stress nuclear imaging) with negative result
- Hospitalization for cardiac or pulmonary disease within past 3 months
- Implanted pacemaker or defibrillator with an upper heart rate limit that would interfere with exercise testing or prescription, or with unknown limit
- Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
- Severe lower limb spasticity (Ashworth >2)
- Known recent history (<3 months) of unstable substance abuse or unstable mental illness
- Major post-stroke depression (Patient Health Questionnaire \[PHQ-9\] ≥ 10) in the absence of depression management by a health care provider
- Currently participating in physical therapy or another interventional study targeting walking function
- Recent (<2 weeks) or planned changes in lower limb orthotic or spasticity management
- Foot drop or lower limb joint instability without adequate stabilizing device, as assessed by a physical therapist
- Clinically significant neurologic disorder other than stroke or unable to walk outside the home prior to stroke
- Unable to walk outside the home prior to stroke
- Other significant medical condition likely to limit improvement or jeopardize safety as assessed by a physical therapist (e.g. joint contracture, gait limited by pain)
- Pregnancy
- Previous exposure to fast treadmill walking (>3 cumulative hours) in the past year
सिनसिनाटी विश्वविद्यालयअध्ययन उत्तरदायी पक्ष
Pierce Boyne, मुख्य अन्वेषक, Associate Professor, University of Cincinnati
अध्ययन केंद्रीय संपर्क
संपर्क: Madison Yeazell, 513-558-7487, [email protected]
3 1 देशों में अध्ययन स्थान
Delaware
University of Delaware, Newark, Delaware, 19713, United States
Jane Diehl, संपर्क, [email protected]
Darcy Reisman, PT, PhD, मुख्य अन्वेषक
भर्ती जारी
Kansas
University of Kansas Medical Center, Kansas City, Kansas, 66160, United States
Sasha Moores, संपर्क, 913-588-2697, [email protected]
Sandra Billinger, PT, PhD, मुख्य अन्वेषक
भर्ती जारी
Ohio
University of Cincinnati, Cincinnati, Ohio, 45267, United States
Madison Yeazell, संपर्क, 513-558-7487, [email protected]
भर्ती जारी