Skill-building through Task-Oriented Motor Practice (STOMP) intervention for activities of daily living: study protocol for a randomized, single blinded clinical trial.

Background: Progressive disability in activities of daily living (ADL) is inevitable for people with Alzheimer's disease and related dementias (ADRD). Attempts to slow or prevent ADL disability have been unsuccessful despite making progress in behavioral training methods. Missing from this research is an emphasis on how we maximize a patient's engagement during training and the rigorous examination of implementation protocols (dosing and training methods) which may advantage learning in people with ADRD. Our team addressed this gap with the development of the STOMP (Skill-building through Task-Oriented Motor Practice) intervention which creates methods for obtaining ADL goals that support "personhood" and tests high-intensity protocols that appear to advantage learning and sustained learning over time. Through this study, we aim to evaluate differential outcomes by dose levels as well as assess the moderating effects of attention to task during training.

Methods/design: Randomized-controlled trial with 32 participants with dementia assigned to either the original, intensive STOMP protocol (3 hours/day, 5 days/week for 2 weeks) or a less-intensive STOMP protocol (1 hour/day, 2 days/week for 2 weeks) delivered by an occupational therapy assistant in the home. ADL training is delivered using motor learning theory techniques of blocked practice, continuous verbal praise, errorless learning and intense dosing schedules. Inclusion criteria: English speaking, adults 50-80 years old that live with a legally-authorized representative that can provide consent, who can follow a one-step command, have three ADL goals they want to address and can participate in an intense therapy protocol. Exclusions include diagnoses of Creutzfeldt-Jakob Dementia, delirium or receptive/global aphasia. Recruitment will occur through direct mailing, physician referral and media/support group presentations. Blinded occupational therapists will complete baseline, post-intervention and 3-month follow-up assessments in the home. Repeated measures ANOVA and graphs will be used to interpret and display results.

Discussion: Through this protocol, we will examine differential outcomes by dose for the STOMP ADL intervention. Our results will inform dosing parameters for future intervention studies for people with ADRD.

Trial Registration: ClinicalTrials.gov identifier: NCT02356055.

Ethical Approval: This study protocol was approved by the University of Oklahoma Health Sciences Center Institutional Review Board (#4648) and will be performed in accordance with the .