Mass Practice of Activities of Daily Living in Dementia (STOMP)

NCT02356055 | Completed DMC

• 1 other identifier: 4648
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

People with Alzheimer's disease and related dementias present with changes in how they think, move and emotionally respond to daily life situations. While type of dementia will dictate how severe certain symptoms are, all people with dementia will report a gradual change in how they function in daily life skills. Losing the ability to do daily life tasks, such as using a cell phone, balance a checkbook or get dressed in the morning signifies loss for both the person with dementia and their caregiver. Caregivers that assist with daily life tasks report more depression and anxiety, as well as a higher burden of care. People with dementia that lose the ability to perform daily tasks report more depression and decreased satisfaction with life. Despite gains in research, researchers are still missing important pieces that will improve rehabilitation interventions for improving daily life skills. In order to address the needs of people with dementia, an intervention called Skill-building through Task-Oriented Motor Practice (STOMP) was developed by an occupational therapist. Our team proposes that improvement in daily life skills is possible under certain circumstances. First, the daily life task a person is addressing in rehabilitation should be personally-meaningful and should also be the task practiced in therapy which is called "task-oriented training". For example, a person that is having trouble making a sandwich should practice making a sandwich. Second, the investigators propose that people with dementia need a lot of "correct practice" so that the brain has time to "rewire" how to do the task correctly. Therefore, when patients practice tasks using STOMP, investigators do not allow our participants to make errors and patients practice for long periods of time. Investigators also incorporate and provide new technology into training such as medication reminder alarms and photo phones which allow you to dial a number by choosing a loved one's picture. In this pilot study, the investigators want to look more closely at the how the amount of time you practice influences study outcomes. The investigators believe that the findings from this study will support our belief that more time in therapy is needed to enhance how someone with dementia learns.

Conditions

Dementia; Alzheimer's Disease

Keywords

activities of daily living; massed practice; occupational therapy

Outcome Measures

Primary Outcomes (1)

• 5 point Observation of Activities of Daily Living

  The investigator observes ADL and then using an ordinal measure (-2, -1, 0, 1, 2), the researcher breaks the patient goal into five possible scenarios where "0" equals the intended goal (determined after researcher observation); negative scores represent "much less" and "somewhat less" than the expected outcome and positive scores represent "somewhat more" and "much more" than expected outcome.

  Baseline

Secondary Outcomes (6)

• Frequency of Behavioral Responses during the Trial

  Daily for 2 weeks

• 10 point Caregiver Perception of Activity of Daily Living Performance and Satisfaction with Performance

  Baseline

• Change in 10 point Caregiver Perception of Activity of Daily Living Performance and Satisfaction with Performance

  Post-intervention (within 72 hours)

• Retention of 10 point Caregiver Perception of Activity of Daily Living Performance and Satisfaction with Performance

  90 days

• Change in Observation of Activity of Daily Living

  Post-intervention (within 72 hours)

Study Arms (2)

Intensive Protocol

EXPERIMENTAL

Participants in this group will receive the Skill-building through Task-Oriented Motor Practice (STOMP) intervention 3 hours/day, 5 days/week for 2 weeks. Participants will choose functional goals that have an identifiable beginning and concluding step for creation of "practice-able" steps for task-oriented training. Practice-able steps will embed both task modifications and assistive technology determined by the OT to support performance and will be situated contextually within the participant's habits and environment. Each group will practice the task as many times as possible during their allotted time in training. For the intensive protocol, each hour of training will focus on 1 of 3 identified goals and will include 50 minutes of intervention and a 10 minute break.

Behavioral: STOMP (Skill-building through Task-Oriented Motor Practice)

Less-Intensive Protocol

ACTIVE COMPARATOR

Participants in this group will receive the Skill-building through Task-Oriented Motor Practice (STOMP) intervention 1 hour/day, 2 days/week for 2 weeks. Participants will choose goals that have an identifiable beginning and concluding step for creation of "practice-able" steps for task-oriented training. Practice-able steps will embed both task modifications and assistive technology determined by the OT to support performance and will be situated contextually within the participant's habits and environment. Each group will practice the task as many times as possible during their allotted time in training. In the less-intensive protocol, each of the 3 ADL goals will be practiced as many times as possible within 20 minutes of the scheduled hour.

Behavioral: STOMP (Skill-building through Task-Oriented Motor Practice)

Interventions

STOMP (Skill-building through Task-Oriented Motor Practice) BEHAVIORAL

The STOMP intervention is a package including family-centered goals, task-specific training delivered through motor learning and errorless learning principles. It is unique in the use of massed practice (high-dosage) therapy.

Intensive Protocol; Less-Intensive Protocol

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lives in the community and speaks English
• adult aged 50-90 years old
• lives with someone who can provide consent to be in the study
• diagnosed with some form of dementia
• cognitive score on the Mini-Mental Status Examination score \>10 but ≤25
• able to understand and follow one step commands
• can move one arm sufficiently for practicing tasks
• participant or family member can identify three goal areas related to self-care or home management
• able to participate in 3 hours of daily therapy in their home environment for 2 consecutive weeks

You may not qualify if:

• Creutzfeldt-Jakob Dementia, delirium or a progressive neurological condition such as Parkinson's disease
• receptive or global aphasia
• uncorrected vision/hearing

Sponsors & Collaborators

• University of Oklahoma: lead
• VA Office of Research and Development: collaborator
• OU Medical Center: collaborator
• Oklahoma Shared Clinical and Translational Resources: collaborator
• Alzheimer's Association: collaborator

Related Publications (1)

• Ciro CA, Stoner J, Prodan C, Hershey L. Skill-building through Task-Oriented Motor Practice (STOMP) intervention for activities of daily living: study protocol for a randomized, single blinded clinical trial. Clin Trials Degener Dis. 2016 Apr-Jun;1(2):45-50. doi: 10.4103/2468-5658.184743. Epub 2016 Jul 7.

  PMID: 29071307 DERIVED

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Study Officials

• Carrie A Ciro, PhD, OTR/L

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: February 5, 2015
• Study Start: October 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 21, 2016

Record last verified: 2016-11