Dietary Intervention With the Modified Atkins Diet in Stroke Rehabilitation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|