Strategy Training for People With Aphasia After Stroke

NCT03593876 | Terminated Results DMC

• 2 other identifiers: PRO18050075R01HD074693
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

One-third to one-half of acute strokes result in newly acquired cognitive impairments. Approximately 30 to 40% of people in the acute phase of stroke also sustain communication impairments. Stroke-related cognitive impairments are associated with significant functional disability, as indicated by the inability to regain independence in daily activities. The overall aim of this study is to examine the feasibility of an adapted form of strategy training for people with communication impairments who are admitted to inpatient rehabilitation. These analyses will address a critical gap in current rehabilitation research, namely the exclusion of people with communication impairments in acute stroke rehabilitation clinical trials, and provide pilot data to inform the design of future inclusive clinical trials seeking to reduce disability after stroke.

Conditions

Strategy Training

Keywords

Stroke; Aphasia; Rehabilitation; Cognition; Disability

Outcome Measures

Primary Outcomes (1)

• Mean Patient-therapist Communication Score

  Measure of Participation in Conversation (MPC) Interaction score greater than or equal to 2. The scale assesses the degree of participation executed by the participant with communication impairment during supported conversation. Scores range from 0=no participation/comprehension to 4=full participation/comprehension.

  Baseline to Post-Intervention (up to 3 weeks)

Secondary Outcomes (2)

• Change in Independence With Daily Activities

  Baseline to 6 months

• Change in Cognition

  Baseline to 6 months

Study Arms (1)

Strategy Training

EXPERIMENTAL

Strategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice.

Behavioral: Strategy Training

Interventions

Strategy Training BEHAVIORAL

This study will use an adapted form of strategy training for people with communication impairments.

Strategy Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary diagnosis of acute stroke
• admission to acute rehabilitation
• mild to moderate aphasia but able to understand and express communication with verbal, written, and/or augmentative communication (score of 1 or 2 on the National Institutes of Health Stroke Scale item 9, or score 1 to 5 on the Boston Diagnostic Aphasia Examination Severity Scale)

You may not qualify if:

• pre-stroke diagnosis of dementia
• severe global aphasia (Boston Diagnostic Aphasia Examination Severity Scale score of 0)
• dysarthria as the only communication impairment (score of 1 or 2 two on the National Institutes of Health Stroke Scale item 10, but score of 0 on item 9)
• current major depressive disorder (unless treated and in partial remission), bipolar disorder, or any other psychotic disorder (indicated by PRIME-MD)severe global aphasia (Boston Diagnostic Aphasia Examination Severity Scale score of 0)

Sponsors & Collaborators

• University of Pittsburgh: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Stroke; Aphasia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Elizabeth Skidmore
• Organization: University of Pittsburgh

skidmore@pitt.edu

(412) 383-6617

Study Officials

• Elizabeth R. Skidmore, PhD, OTR/L

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 20, 2018
• Study Start: July 23, 2018
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: September 24, 2021
• Results First Posted: September 24, 2021

Record last verified: 2021-08

Locations

US (1)