Strategy Training for People With Aphasia After Stroke

Strategy Training Clinical Trial

Official title:

Strategy Training for People With Aphasia After Stroke

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03593876
• Other study ID #: PRO18050075
• Secondary ID: R01HD074693
• Status: Terminated
• Phase: N/A
• Start date: July 23, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2021
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This pilot study will use a descriptive case series design with repeated measures to assess the feasibility of an adapted form of strategy training for people with communication impairments after acute stroke. The investigators will recruit people with aphasia due to stroke admitted to the inpatient rehabilitation units and administer the adapted form of strategy training one session per day 5 days per week for 10-15 sessions. The investigators will assess the feasibility of the intervention based on feedback from participants and therapists. These data will serve as pilot data to inform the design of a future clinical trials for people with cognitive impairments after stroke, including people with communication impairments. These efforts will allow the investigators to test new models to support optimal interventions for individuals with stroke-related cognitive impairments, including people with communication impairments who are among those most vulnerable for long-term disability.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Aphasia
• Strategy Training

Intervention

Behavioral:
• Strategy Training
This study will use an adapted form of strategy training for people with communication impairments.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Independence With Daily Activities	Change in independence measured with the Functional Independence Measure. The FIM assesses 18 tasks in 6 functional domains (self-care, sphincter control, transfers, locomotion, communication and social cognition) using a scale of 1 (dependent) to 7 (independent). Scores range from 18 to 126. Higher values represent better outcomes. The a priori criterion for change was a medium effect size of change (Cohen's d=0.5).	Baseline to 6 months
Secondary	Change in Cognition	Change in cognition measured with the Cognitive Linguistic Quick Test Executive Function Score. The severity score measures executive functions using 4 tasks (symbol trails, generative naming, mazes, and design generation). The score ranges from 40 (within normal limits) to 0 (severe impairment). Higher values represent better outcomes. The a priori criterion for change was a medium effect size of change (Cohen's d=0.5).	Baseline to 6 months