NCT06013878 Biomechanical Validation of the CATT

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 160 participants in total. It began in 2024-07-24 with a primary completion date of 2026-09-01.

Brief Summary

As of 2020, 53 million Americans provide unpaid care to an individual with a disability. One commonly performed activity of daily living (ADL) provided by informal caregivers is assisted transfers, which requires moving an individual from one surface to another. Approximately 94% of informal caregivers who assist with ADLs to persons with adult-onset chronic physical disabilities affecting mobility reported musculoskeletal discomfort, with pain and discomfort made worse by performing caregiving activities. Although many informal caregivers assist with transfers, most have never received any formal training in proper manual lifting or mechanical lifting techniques. Improper transfer techniques can be detrimental to not only caregiver health but also to the persons they assist resulting in shoulder injury, bruising and pain from manual lift techniques, hip fractures from falls, and skin tears from shear force that occurs with sliding during transfers. Current standard of care provides limited in-person training of caregivers, as most of the rehabilitation process is client-focused. When training is provided clinicians have no means to objectively evaluate if proper techniques are being performed at discharge or when the caregiver and care recipient return home. For this reason, an outcome measure called the Caregiver Assisted Transfer Technique Instrument (CATT) was developed to provide a quick, objective way to evaluate proper technique of caregivers who provide transfer assistance to individuals with disabilities. The CATT evaluates the caregiver's performance on setup, quality of the task performance, and results. After a formal assessment through stakeholder review involving clinicians, informal caregivers, and individuals with physical disabilities who require transfer assistance, the CATT was expanded to include two versions; one that evaluates manual lift technique (CATT-M) and one that evaluates mechanical lift techniques (CATT-L). However, the CATT must undergo further testing with informal caregivers and the individuals they assist to determine if the CATT is a reliable, valid, and responsive tool for identifying skill deficits in caregivers performing assisted transfers. The purpose of this study is to establish the psychometric properties (reliability, validity, and responsiveness) of the CATT and to evaluate the effects of an individualized training session for participants who have transfer technique deficits as identified by the CATT. The long-term goal of this research is to develop the CATT so that it can be used as an objective indicator of transfer performance as well as guide training and educational interventions for informal caregivers to reduce the risk of musculoskeletal pain and injury associated with assisted transfers.

Eligibility Criteria

Inclusion Criteria: Individuals who use assistance with transfers and their caregivers will be recruited for this study. Caregiver participants will be included in the study if they meet the following criteria: 1. at least 18 years old 2. routinely provide transfer assistance to an adult with a physical disability 3. serving as a caregiver for at least 3 months 4. no formal didactic or structured training on assisted transfer techniques received as part of a professional degree or training program Care recipient participants will be included in the study if they meet the following criteria: 1. at least 18 years old, 2. has a physical disability diagnosis for at least one year 3. requires assistance with transfers 4. currently receives care from an informal caregiver Exclusion Criteria: Caregiver participants will be excluded if they: 1\) have a current or recent history of back, neck, or other type of musculoskeletal injury within the last 6 months that would be exacerbated by performing an assisted transfer Care recipient participants will be excluded if they: 1. have existing pressure ulcers or a recent history of pressure ulcers within the last 3 months 2. have any recent upper extremity injuries (within the last 6 months) that could be exacerbated by being transferred

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