Dietary Intervention With the Modified Atkins Diet in Stroke Rehabilitation
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|ClinicalTrials.gov Identifier: NCT01820663|
Recruitment Status : Completed
First Posted : March 29, 2013
Last Update Posted : February 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Stroke Ischemic Stroke||Other: Modified Atkins Diet Other: Control diet||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Dietary Intervention in Stroke Recovery in the Acute Rehabilitation Setting With the Modified Atkins Diet.|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Experimental: Modified Atkins Diet
Patients will receive a 14 day menu consisting of the Modified Atkins diet, a low-carbohydrate, high protein, high fat diet.
Other: Modified Atkins Diet
A high fat, high protein, low- carbohydrate diet
Placebo Comparator: Control Diet
Patients will receive a diet (e.g. regular, low cholesterol, diabetic) determined by the attending physician.
Other: Control diet
The control diet is a diet determined by the attending physician caring for the patient and may consist of either a low sodium diet, a low sodium/ low cholesterol diet, a regular diet or a diabetic diet.
- Change in Upper Extremity Fugl Meyer Motor Score [ Time Frame: assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge ]The Upper Extremity Fugl Meyer Motor Score is used to assess impairment in upper extremity function. Individuals are asked to complete a certain sequence of movements, and quality of movements is scored.
- Change in Montreal Cognitive Assessment (MOCA) [ Time Frame: assessed upon beginning of the study, discharge from Burke Rehabilitation Hospital (average 25 days post study enrollment) and at 3 months post discharge ]The MOCA is an assessment of cognitive impairment and evaluates several cognitive domains.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01820663
|United States, New York|
|Burke Rehabilitation Hospital|
|White Plains, New York, United States, 10605|
|Principal Investigator:||Carolin I Dohle, MD||Burke Rehabilitation Hospital|