Skip to main content
OpenTrials
Completed

NCT Number: NCT03511300

Ready, Set, Goal: Motivation and Cognition in Stroke Patients

Apathy is a syndrome of reduced motivation, characterized by diminished goal-directed behaviours (e.g., lack of effort), decreased goal-oriented cognitions (e.g., lack of interest) and blunted affect. Apathy is present in 20-50% of individuals after experiencing a stroke. Despite the detrimental impact of reduced goal-directed behaviours and cognitions on activities of daily living and cognition in stroke patients, interventions for increasing motivation (reducing apathy) have yet to be examined in this population. This study will examine the effect of goal-setting instructions on cognitive performance in stroke patients. The investigators hypothesize that in stroke patients, goal-setting instructions will improve cognitive performance relative to standard instructions. If goal-setting instructions are effective in improving cognitive performance, it may indicate that treatments targeting apathy could serve as a novel way to improve cognitive outcomes and enhance patient quality of life post-stroke.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Lethargy Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

About this study

The study is a single-blind randomized controlled trial. It employs a mixed design, with a between-subjects variable (goal-setting instructions versus standardized instructions) and a within-subjects variable (pre-post instructional manipulation). It is a one-time intervention lasting 1-2 hours. Investigators plan to enroll 72 patients in this study. All participants will complete neuropsychological measures to assess their baseline performance. The baseline measures include Trial 1 of the CVLT-II Alternate Form, the Digit Span Test, Center for Epidemiologic Studies Depression Scale, Controlled Oral Word Association Test, Semantic Fluency Test, Apathy Evaluation Scale and Trail Making Test. After the baseline measures are completed, all participants will rate their level of motivation on a scale from 1 (extremely unmotivated) to 100 (extremely motivated), which will act as a pre-manipulation check measure, their level of fatigue on a scale from 1 (extremely not fatigued) to 100 (extremely fatigued), and their level of anxiety from 1 (extremely not anxious) to 100 (extremely anxious; 1 minute).

After completing the baseline measures and rating scales, half (n = 36) of the participants will be randomly assigned to the goal-setting instruction group ("goal-setting group"). Motivation will be enhanced by asking participants to perform 20% better than their previous performance on a similar task, and translating that into a number (e.g., "On this task, you generated 10 words when I asked you to name as many words as you could that start with the letter "F." Now, for the next letter, I want you to generate 12 words."). The remainder of the participants (n = 36) will be assigned to the "standard instruction group," where they will only receive the standardized instructions for completing the tests.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient attending Secondary Stroke Prevention Clinic
  • Ischemic Stroke
  • Presenting at least 3 months after stroke
  • Modified Rankin Scale Score of at least 4
  • Fluent in English

Exclusion criteria

  • Marked aphasia
  • Marked neglect
  • Severe visual impairment
  • Inability to complete 1 hour of cognitive testing in English.

Treatment and study plan

Goal-Setting Instructions

Behavioral

In the goal-setting instruction condition, participants will be asked to increase their performance by 20% from the previous similar test (e.g., "On this task, you generated 10 words when I asked you to name as many words as you could that start with the letter 'F.' Now, I want you to aim to generate at least 12 words for the letter 'F'.")

Standard Instructions

Behavioral

Participants in this group will receive the standardized instructions for completing the tests, as outlined in the test appendices.

Primary outcomes

  1. Controlled Oral Word Association Task

    Time frame: 10 minutes

    Participant performance on Controlled Oral Word Association Task in goal setting instructions group compared to standard instruction group.

Secondary outcomes

  1. Motivation Level

    Time frame: 2 minutes

    Participant self-reported motivation level in goal setting instruction group versus standard instruction group.

  2. Cognitive Performance on Semantic Fluency Test

    Time frame: 10 minutes

    Participant performance on Semantic Fluency Test in goal setting instructions group compared to standard instruction group.

  3. Digit Span Test

    Time frame: 10 minutes

    Participant performance on Digit Span Test in goal setting instructions group compared to standard instruction group.

  4. California Verbal Learning Test-II

    Time frame: 10 minutes

    Participant performance on California Verbal Learning Test-II in goal setting instructions group compared to standard instruction group.

  5. Trail Making Test

    Time frame: 10 minutes

    Participant performance on Trail Making Test in goal setting instructions group compared to standard instruction group.

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • University of Ottawa

Registry information

Official study title

Ready Set Goal: A Randomized Controlled Trial Examining Motivation and Cognition in Stroke Patients

Acronym: ACE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 27, 2018
Registry last updated
Oct 29, 2019

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.

Related clinical trials

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