NCT03593876

Strategy Training for People With Aphasia After Stroke

Terminated NA Results posted Last updated 24 September 2021

What this trial tests

NA trial testing Strategy Training in Strategy Training in 16 participants. Terminated before completion.

Timeline

23 July 2018

Primary endpoint
1 August 2020

1 August 2020

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	23 July 2018
Primary completion	1 August 2020
Estimated completion	1 August 2020
Sites	1 location across United States

Drugs / interventions tested

• Strategy Training

Conditions studied

• Strategy Training — all drugs for Strategy Training →

Sponsor

University of Pittsburgh

Who can join

18 and older, any sex, with Strategy Training. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Patient-therapist Communication Score Primary · Baseline to Post-Intervention (up to 3 weeks)

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.

Group	Value	95% CI
Strategy Training	3.0	± 1.0

Change in Independence With Daily Activities Secondary · Baseline to 6 months

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).

Group	Value	95% CI
Strategy Training	51.7	± 21.0

Change in Cognition Secondary · Baseline to 6 months

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).

Group	Value	95% CI
Strategy Training	1.8	± 3.5

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Metacognitive Strategy Training Is Feasible for People With Aphasia.
   Kersey J, Evans WS, Mullen K, Askren A, et al · · 2021 · cited 8× · PMID 34176360 · DOI 10.1177/15394492211023196