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Completed

NCT Number: NCT01934621

Adapting Daily Activity Performance Through Strategy Training

Individuals with cognitive impairments after stroke sustain significant disability in their daily tasks, and account for a significant proportion of stroke-related healthcare costs. The proposed study examines a novel intervention, strategy training, that shows promise for helping individuals with stroke-related cognitive impairments reduce disability in daily tasks, which may lead to reductions in healthcare costs. We predict that strategy training will result in significantly greater independence 6 months after stroke compared to an attention control intervention, and that strategy training may reduce cognitive impairments.

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Key information

Conditions

Strategy Training Attention Control Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders 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 higher order cognitive functions (EXIT-14 ≥ 3)

Exclusion criteria

  • pre-stroke diagnosis of dementia in the medical record
  • inability to follow two- step commands 80% of the time
  • severe aphasia (BDAE ≤ 1)
  • current major depressive, bipolar, or psychotic disorder
  • drug or alcohol abuse within 3 months

Treatment and study plan

Strategy Training

Behavioral

Attention Control

Behavioral

Primary outcomes

  1. Change in Independence with Daily Activities

    Time frame: Baseline to Month 6

    Moderate effect size of difference between groups in independence (measured with the Functional Independence Measure)

Secondary outcomes

  1. Change in Executive Functions

    Time frame: Baseline to Month 6

    Moderate effect size of difference between groups in independence (measured with selected indices of the Delis-Kaplan Executive Function System)

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

Closing the Gap: Early Intervention for Cognitive Disability After Stroke

Acronym: ADAPTS

Important dates

Study start
2013
Primary completion
2018
Study completion
2020
First posted
Sep 4, 2013
Registry last updated
Nov 5, 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.

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