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Despite numerous kinds of evidence on functional health and CNS protection of intermittent fasting after injuries were found in many brain-, and spinal cord-damaged animal models, there has yet to be any clinical study of intermittent fasting after acute ischemic cerebral infarction. The aim of this study is to evaluate the neurological, functional and clinical efficacy of intermittent fasting in patients after acute ischemic stroke.
In order to verify the validity and clinical efficacy of intermittent fasting for neurological and functional effects of ischemic cerebral infarction, the first ischemic stroke (diagnosed within 1 year through brain MRI / CT) patients will be randomly assigned to intermittent fasting group or control group. In both groups, physical therapy, occupational therapy and speech therapy will be provided during 3 hours in total a day. The intermittent fasting group should maintain intermittent fasting for no less than 12 hours or more every day during the rehabilitation period (at least 1 week), and the control group is able to eat all of the hospital meals and all the participants want without any time limit. The efficacy of intermittent fasting is to be verified by performing the electro-physiological tests and functional evaluations before participation, 1st week, 2nd weeks after participation, before discharge, 3 months, and 6 months after the stroke onset.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent Fasting | Experimental | Over rehabilitation treatment during and admission (at least 1 week), intermittent fasting (IF) for more than 12 hours (water can be allowed). For subgroup assignment, participants can choose IF1 (eat early in the evening and late in the morning) or Post-IF2 (eat the remaining two meals without breakfast), depending on own their faver. |
|
| Ad libitium | No Intervention | Participants will be allowed to have hospital meals and all the desired intake without time limit. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Fasting | Dietary Supplement | The aforementioned intermittent fasting in arm/group descriptions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Surface electromyography | root mean square and root peak square of compound motor action potential | 1 day before the initiation of intervention, and 6 months after the stroke onset |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Korean-modified Barthel index | Korean version-Modified Barthel Index (minimum of 0 and maximum scores of 100); higher values and a better outcome. | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Mini mental status exam | Mini mental status exam(minimum of 0 and maximum scores of 30); higher values and a better outcome. | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset |
| Change of Beck depression inventory |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang Ho Hwang | Contact | +82-52-250-7210 | chhwang1220ciba@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chang Ho Hwang, M.D., Ph.D. | Ulsan University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ulsan University Hospital | Recruiting | Ulsan | 682-714 | South Korea |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Beck depression inventory(minimum of 0 and maximum scores of 63); higher values and a worse outcome. |
| 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset |
| Change of Wecsler aphasia battery | Wecsler aphasia battery(minimum of 0 and maximum scores of 100); higher values and a better outcome. | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset |
| Change of Berg balance scale | Berg balance scale(minimum of 0 and maximum scores of 56); higher values and a better outcome. | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset |
| Change of Functional Ambulation Category | Functional Ambulation Category(minimum of 0 and maximum scores of 5); higher values and a better outcome. | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset |
| Change of Motricity Index | Motricity Index(minimum of 0 and maximum scores of 99); higher values and a better outcome. | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset |
| Change of 10m walking test | 10m walking test | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset |
| Change of Grasping force (kg) | Grasping force (kg) | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset |
| Change of 9-hole pegboard | 9-hole pegboard | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset |
| Change of Jebsen Taylor test | Jebsen-Taylor Hand Function Test | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset |
| Change of Nottingham sensory scale | Nottingham sensory scale(minimum of 0 and maximum scores of 20); higher values and a better outcome. | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset |
| Change of Arm motor Fugl-Mayer scale | Arm motor Fugl-Mayer scale; wrist & hand/proximal arm(minimum of 0 and maximum scores of 24 and of 34, respectively ); higher values and a better outcome. | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset |
| Change of Stroke impact scale | Hand motor, Stroke Impact Scale (minimum of 12 and maximum scores of 60); higher values and a better outcome. | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset |
| Change of Ashworth scale | Ashworth scale; elbow, wrist, knee & ankle(minimum of 0 and maximum scores of 4); higher values and a worse outcome. | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset |
| Change of Knee joint kinesthesia | The smallest iso-kinetic angle from which the participants could detect any passive flexion or extension movement of their own knee, using Biodex; (minimum of 0 and maximum scores of 360 degree); higher values and a worse outcome. | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset |
| Change of Behavioral inatention test | Behavioral inatention test(minimum of 0 and maximum scores of 146); higher values and a better outcome. | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset |
| Change of Apraxia screen of Tulia | Apraxia screen of (minimum of 0 and maximum scores of 12); higher values and a better outcome. | 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset |
| Change of motor evoked potential | Amplitude (uV) of motor evoked potential was recorded on abductor pollicis brevis and extentor digitorum brevis following trans-cranial magnetic stimulation for cortico-spinal excitability. | 1 day before the initiation of intervention, and 6 months after the stroke onset |
| Change of Weight | Weight (Kg) | 1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention |
| Change of Temperature | temperature (Celsius) | 1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention |
| Change of Serum glucose level | Serum glucose level (mg/ml) | 1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention |
| Change of Hypoglycemia-related severity | Assessment of hypoglycemic symptoms using Likert scale (minimum of 0 and maximum scores of 10); higher values and a worse outcome. | every day following the start of intervention until 2 weeks of intervention |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |