Dietary Intervention With the Modified Atkins Diet in Stroke Rehabilitation

Completed

Phase 1/2 Results N/A

Update History

25 Feb '16
The eligibility criteria were updated.
New
Inclusion Criteria: - Age 18-99 - First time unilateral hemispheric ischemic stroke. Not more than 12 weeks after acute stroke. - Burke Stroke Rehabilitation Unit Inpatient. - Preserved cognitive ability to understand commands and participate in outcome measures and to give informed consent. In patients with aphasia, cognitive ability to give consent will be determined by a physician. - Upper extremity motor impairment with an UE Fugl Meyer score ≤ 56/66 - Independence in ADLS/ absence of major impairment prior to stroke Exclusion Criteria: - Hemorrhagic stroke - Uncontrolled hyperlipidemia with LDL > 250 on admission - Uncontrolled Diabetes mellitus with BS > 300 averaged over the first day of admission - Nutritional risk as defined by BMI < 18.5 or by a score of 2 or higher on the Malnutrition Universal Screening Tool (scores BMI, % of unplanned weight loss in last 3-6 months and question whether patient is acutely ill) - Decreased renal function with eGFR <30% - Stage III and IV pressure ulcers - Osteoporosis not sufficiently treated with oral Calcium and Vitamin D supplements - CHF as defined by class III or worse - Hypersensitivity/allergy to cholesterol lowering medications - H/o kidney stones within last 1 year prior to stroke or medications predisposing to kidney stones such as Topamax, carboanhydrase inhibitors - Inability to tolerate an oral diet and need for tube feeds - Active enrollment in any other interventional studies at Burke; enrollment in observational studies or studies using TMS as a measurement may not pose exclusion criteria - Cognitively unable to follow instructions.
Old
Inclusion Criteria: - Age 18-99 - First time unilateral hemispheric ischemic stroke. Not more than 12 weeks after acute stroke. - Burke Stroke Rehabilitation Unit Inpatient. - Preserved cognitive ability to understand commands and participate in outcome measures and to give informed consent. In patients with aphasia, cognitive ability to give consent will be determined by a physician. - Upper extremity motor impairment with an UE Fugl Meyer score ≤ 56/66 - Independence in ADLS/ absence of major impairment prior to stroke Exclusion Criteria: - Hemorrhagic stroke - Uncontrolled hyperlipidemia with LDL > 250 on admission - Uncontrolled Diabetes mellitus with BS > 300 averaged over the first day of admission - Nutritional risk as defined by BMI < 18.5 or by a score of 2 or higher on the Malnutrition Universal Screening Tool (scores BMI, % of unplanned weight loss in last 3-6 months and question whether patient is acutely ill) - Decreased renal function with eGFR <30% - Stage III and IV pressure ulcers - Osteoporosis not sufficiently treated with oral Calcium and Vitamin D supplements - CHF as defined by class III or worse - Hypersensitivity/allergy to cholesterol lowering medications - H/o kidney stones within last 1 year prior to stroke or medications predisposing to kidney stones such as Topamax, carboanhydrase inhibitors - Inability to tolerate an oral diet and need for tube feeds - Active enrollment in any other interventional studies at Burke; enrollment in observational studies or studies using TMS as a measurement may not pose exclusion criteria - Cognitively unable to follow instructions.
A location was updated in White Plains.
New
The overall status was removed for Burke Rehabilitation Hospital.