Abstract
BACKGROUND: The purpose of this pilot trial was to evaluate the impact of increased frequency of physical therapy sessions with error augmentation on functional mobility and disability outcomes in patients with acute stroke. We hypothesized that participants receiving frequent error augmentation physical therapy interventions (F-EA-PT) would demonstrate a higher degree of improvement on functional mobility and disability measures from admission to three post-intervention time points (treatment day 3, discharge, or 90-day follow-up). METHODS: We allocated 100 individuals to receive either F-EA-PT or standard-of-care physical therapy (SOC-PT). The F-EA-PT group received physical therapy with error augmentation twice daily for 3 out of the first 5 days of hospitalization, and daily treatment sessions thereafter. Error augmentation training emphasizes impairments throughout mobility to challenge the individual, rather than facilitating normal movement patterns. The SOC-PT group received treatment once daily for 3 to 5 days per week. Assessments included National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), Activity Measure for Post-Acute Care (AM-PAC) and Postural Assessment Scale for Stroke (PASS). A repeated measures mixed model approach compared treatment groups for all outcomes. RESULTS: The F-EA-PT group demonstrated larger magnitudes of reduction of -1.34 on NIHSS (p=0.0426) and -0.81 on mRS (p=0.0037) from admission to 90-day follow-up compared to the SOC-PT group. The F-EA-PT group demonstrated larger magnitudes of change in AM-PAC of 2.12 at treatment day 3 (p=0.0009) and 2.75 at discharge (p<0.0001) compared to SOC-PT. F-EA-PT group experienced greater improvement in PASS over the SOC-PT group with a difference in change of 4.08 at treatment day 3 (p=0.0019) and 4.45 at discharge (p=0.001). CONCLUSIONS: Intervening with a regimen focused on increased frequency and error augmentation from a physical therapy standpoint was safe with only one adverse event. It demonstrated significant improvements in functional outcomes post stroke above those seen with standard-of-care regimen, as evidenced by PASS and AM-PAC scores. REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT04778475.Medical University of South Carolina IRB II Approved 04/20/2021 PRO00108635.