NCT03789409.

Study name	Intermittent fasting following acute ischemic stroke
Methods	Randomised controlled trial
Participants	68 participants Ages Eligible for Study: 20 years and older (adult, older adult) Sexes Eligible for Study: all Accepts Healthy volunteers: no Inclusion Criteria Patients who was diagnosed first ischaemic stroke within preceding 1 year through brain MRI/CT
Interventions	Arm Intervention/treatment Experimental: Intermittent Fasting 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 their own their favour. Dietary Supplement: Intermittent Fasting The aforementioned intermittent fasting in arm/group descriptions. No Intervention: ad libitum Participants will be allowed to have hospital meals and all the desired intake without time limit.
Outcomes	Primary Outcome Measures : Change of Surface electromyography [ Time Frame: 1 day before the initiation of intervention, and 6 months after the stroke onset ] root mean square and root peak square of compound motor action potential Secondary Outcome Measures: Change of Korean‐modified Barthel index [ Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset ] Korean version‐Modified Barthel Index (minimum of 0 and maximum scores of 100); higher values and a better outcome. Other Outcome Measures: Change of Mini mental status exam [ Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset ] Mini mental status exam(minimum of 0 and maximum scores of 30); higher values and a better outcome. Change of Beck depression inventory [ Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset ] Beck depression inventory(minimum of 0 and maximum scores of 63); higher values and a worse outcome. Change of Wecsler aphasia battery [ Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset ] Wecsler aphasia battery(minimum of 0 and maximum scores of 100); higher values and a better outcome. Change of Berg balance scale [ Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset ] Berg balance scale(minimum of 0 and maximum scores of 56); higher values and a better outcome. Change of Functional Ambulation Category [ Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset ] Functional Ambulation Category(minimum of 0 and maximum scores of 5); higher values and a better outcome. Change of Motricity Index [ Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset ] Motricity Index(minimum of 0 and maximum scores of 99); higher values and a better outcome. Change of 10m walking test [ Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset ] 10m walking test Change of Grasping force (kg) [ Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset ] Grasping force (kg) Change of 9‐hole pegboard [ Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset ] 9‐hole pegboard Change of Jebsen Taylor test [ Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset ] Jebsen‐Taylor Hand Function Test Change of Nottingham sensory scale [ Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset ] Nottingham sensory scale(minimum of 0 and maximum scores of 20); higher values and a better outcome. Change of Arm motor Fugl‐Mayer scale [ Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset ] 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. Change of Stroke impact scale [ Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset ] Hand motor, Stroke Impact Scale (minimum of 12 and maximum scores of 60); higher values and a better outcome. Change of Ashworth scale [ Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset ] Ashworth scale; elbow, wrist, knee & ankle(minimum of 0 and maximum scores of 4); higher values and a worse outcome. Change of Knee joint kinaesthaesia [ Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset ] 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. Change of Behavioural intention test [ Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset ] Behavioural intention test(minimum of 0 and maximum scores of 146); higher values and a better outcome. Change of Apraxia screen of Tulia [ Time Frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset ] Apraxia screen of (minimum of 0 and maximum scores of 12); higher values and a better outcome. Change of motor evoked potential [ Time Frame: 1 day before the initiation of intervention, and 6 months after the stroke onset ] 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. Change of Weight [ Time Frame: 1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention ] Weight (Kg) Change of Temperature [ Time Frame: 1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention ] temperature (Celsius) Change of Serum glucose level [ Time Frame: 1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention ] Serum glucose level (mg/ml) Change of Hypoglycemia‐related severity [ Time Frame: every day following the start of intervention until 2 weeks of intervention ] Assessment of hypoglycaemic symptoms using Likert scale (minimum of 0 and maximum scores of 10); higher values and a worse outcome.
Starting date	March 4, 2019
Contact information	chhwang1220ciba@gmail.com
Notes	NCT03789409