Examining Rehabilitation Training Methods (GUIDE)

January 6, 2020 updated by: Elizabeth R. Skidmore, PhD, OTR/L, University of Pittsburgh

Guided Versus Directed Training in Acute Stroke Rehabilitation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Guided Training
Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with "practical" skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.
Behavioral: Guided Training
Other Names:
  • Strategy Training
Active Comparator: Directed Training
Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.
Behavioral: Directed Training
Other Names:
  • Direct Skill Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, rehab discharge, month 3, month 6, month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

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

Investigators

  • Principal Investigator: Elizabeth R Skidmore, PhD, OTR/L, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 6, 2016

First Posted (Estimate)

May 9, 2016

Study Record Updates

Last Update Posted (Actual)

January 9, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PRO12040383
  • UL1TR000005 (U.S. NIH Grant/Contract)
  • R03HD073770-01 (U.S. NIH Grant/Contract)
  • R01HD074693-02S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

At present, there is no plan to share data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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