NCT00332800

Brief Summary

Undernutrition after stroke is frequent and is due to cognitive impairment, visuospatial perceptive deficits, hemiparesis, depression and dysphagia. The impact of intensive nutritional supplementation on functional outcome measures in undernourished stroke patient has not been studied.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Oct 2003

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2006

Completed
Last Updated

June 2, 2006

Status Verified

June 1, 2005

First QC Date

May 31, 2006

Last Update Submit

May 31, 2006

Conditions

Stroke

Keywords

Stroke-Nutritional Supplementation-Functional Recovery

Outcome Measures

Primary Outcomes (1)

  • Change in total Functional Independence Measure (TFIM) score, and change in the FIM-cognitive and FIm-motor subscores.

Secondary Outcomes (1)

  • Length of stay (LOS)and discharge disposition.

Interventions

Nutritional SupplementationDRUG

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hemorrhagic and ischemic stroke documented clinically and by neuroimaging.
  • Admission to the Stroke Rehabilitation Service of the Burke Rehabilitation Hospital within 4 weeks of the acute neurological insult.
  • Informed consent, from patient or other responsible person according to Burke IRB standards.
  • Stable medical condition, including cardiac status.
  • Patient able to take diet and medication either orally or via the PEG tube.

You may not qualify if:

  • Patients with prior documented history of alcohol abuse, renal and liver diseases, and malabsorption.
  • Patients medically unstable.
  • Patient's terminal ill (e.g., patients with stroke as a complication of a terminal cancer).
  • Patients participating in any other structured therapeutic trial in the acute care hospital or at Burke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burke Rehabilitation Hospital

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Meheroz H Rabadi, MD, MRCPI

    Burke Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 31, 2006

First Posted

June 2, 2006

Study Start

October 1, 2003

Study Completion

December 1, 2005

Last Updated

June 2, 2006

Record last verified: 2005-06

Locations

US(1)