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STUDY PROTOCOL
Year : 2016  |  Volume : 1  |  Issue : 2  |  Page : 45-50

Skill-building through Task-Oriented Motor Practice (STOMP) intervention for activities of daily living in dementia: study protocol for a randomized controlled clinical trial


1 University of Oklahoma, College of Allied Health, Oklahoma City, OK, USA
2 University of Oklahoma, College of Public Health, Oklahoma City, OK, USA
3 University of Oklahoma, College of Medicine, Oklahoma City, OK, USA

Correspondence Address:
Carrie A Ciro
University of Oklahoma, College of Allied Health, Oklahoma City, OK
USA
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Source of Support: Alzheimer's Association, National Institutes of Health, National Institute of General Medical Sciences, USA, No. 1 U54GM104938 , Conflict of Interest: None


DOI: 10.4103/2468-5658.184743

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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 Skill-building through Task-Oriented Motor Practice (STOMP) 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 in activities of daily living by two different dose levels of the STOMP intervention. Secondarily, we will assess the moderating effects of participant attention to task during training. Methods/Design: A randomized, single blinded, controlled trial with 32 eligible patients with dementia assigned to either the original, intensive STOMP protocol (3 hours per day, 5 days per week for 2 weeks) or a less-intensive STOMP protocol (1 hour per day, 2 days per 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. Blinded occupational therapists will complete baseline, post-intervention and 3-month follow-up assessments in the home. Primary outcomes will be examiner and caregiver rated ADL performance. Secondary outcomes will be the amount of time the participant is engaged in the task (e.g., attention to training). Discussion: Through this protocol, we will examine differential ADL 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 Ethics: 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 Declaration of Helsinki. Informed consent: Written consent will be obtained by the participant's legally-authorized representative as older adults with dementia are considered a vulnerable population. However, in all cases, assent of the participant will also be obtained at the time of consent.


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