Examining Rehabilitation Training Methods

Individuals with cognitive impairments after stroke sustain significant disability in their daily tasks, and account for a significant proportion of stroke-related healthcare costs. This loss of independence is costly because individuals with stroke-related cognitive impairments require more rehabilitation and more resources to support their living, whether in institutional or community settings. The proposed study examines the effects of directed and guided training on the recovery of independence with daily activities in adults with stroke-related cognitive impairments in acute rehabilitation. The investigators predict that patients in both groups will demonstrate significant improvement in independence with daily activities in the first 12 months after rehabilitation admission, but that patients who receive guided training will demonstrate significantly more improvements than patients who received directed training.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Guided Training Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Directed Training Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

primary diagnosis of acute stroke
admission to acute inpatient rehabilitation
impairment in cognitive functions (as indicated by 14-item Executive Interview ≥ 3)

Exclusion criteria

diagnosis of dementia in the medical record
inability to follow two-step commands 80% of the time
severe aphasia (score of 0 or 1 on the Boston Diagnostic Aphasia Examination 3rd Edition Severity Rating Scale)
current untreated major depressive, bipolar, or psychotic disorder (PRIME-MD)
drug or alcohol abuse within 3 months (Mini-International Neuropsychiatric Interview)

Treatment and study plan

Guided Training

Behavioral

Other names: Strategy Training

Directed Training

Behavioral

Other names: Direct Skill Training

Primary outcomes

Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time

Time frame: Baseline, rehab discharge, month 3, month 6, month 12

Differences between groups in mean independence scores (computed from Functional Independence Measure total scores) over time.

The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated for each participant at baseline, discharge, month 3, month 6, and month 12, and mean total scores for each group were calculated at each time point. Differences in mean scores were examined between groups over time with mixed model analyses.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Guided Versus Directed Training in Acute Stroke Rehabilitation

Acronym: GUIDE

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2015
First posted: May 9, 2016
Registry last updated: Jan 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed