AzTrials
AzTrials

Informal CaregiversNCT06013878

Biomechanical Validation of the Caregiver Assisted Transfer Technique Instrument

An observational study of Informal Caregivers and Low Back Pain, run by VA Office of Research and Development at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Informal Caregivers, Low Back Pain, Biomechanics
What is being tested?
Transfer Training with clinician
How many people
160 participants
Where
1 siteUnited States
Study dates
24 Jul 2024to 31 Oct 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Caregivers and care recipients who are eligible for the study will be recruited through community locations, including rehabilitation facilities, organizations that provide services to both caregivers and individuals with physical disabilities, research registries for individuals with disabilities, and at at national and local rehabilitation events, disability conferences and expos.

Who may be able to join

  • 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:
  • routinely provide transfer assistance to an adult with a physical disability
  • serving as a caregiver for at least 3 months
  • 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:
Show all 9Show fewer
  • has a physical disability diagnosis for at least one year
  • requires assistance with transfers
  • currently receives care from an informal caregiver

Who cannot join

  • 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:
  • have existing pressure ulcers or a recent history of pressure ulcers within the last 3 months
  • have any recent upper extremity injuries (within the last 6 months) that could be exacerbated by being transferred

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alicia M Koontz, PhD contact

(412) 383-6596

Alicia.Koontz@va.gov

Nikitha Deepak, MS BS contact

(412) 822-3669

nikitha.deepak@va.gov

United States1 site, 1 recruiting
  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    Pittsburgh, Pennsylvania, 15240

    Alicia M Koontz, PhD, (412) 383-6596, Alicia.Koontz@va.gov

    Nikitha Deepak, MS BS, (412) 822-3669, nikitha.deepak@va.gov

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

The objective of this study is to further establish the psychometric properties of the CATT and to evaluate the effects of an individualized intervention for participants who have transfer technique deficits as identified by the CATT.

Specific Aim 1 (Reliability): Establish the CATT's intra and inter-rater reliability in evaluating the quality of informal caregiver assisted transfer techniques.

Hypothesis 1a: Each item and the total score of the CATT will have excellent intra-rater and interrater reliability (ICC >0.8 for total scores; K>0.8 for individual item scores).

Specific Aim 2 (Validity): Establish the CATT's construct and concurrent validity through relating the scores to caregiver characteristics and to the biomechanical measurement of caregiver techniques.

Hypothesis 2a (Construct Validity): Characteristics of the caregiver including younger age, lower levels of shoulder, neck or back pain, better overall health status, higher income, and higher level of education will predict higher scores on the CATT (indicative of better transfer technique).

Hypothesis 2b (Concurrent Validity): Higher total CATT scores (indicative of better transfer technique) will correlate with lower peak lumbar forces, less trunk flexion and axial rotation, and greater hip and knee flexion.

Specific Aim 3 (Responsiveness): Demonstrate improvement in the quality of assisted transfer technique after individualized training with caregivers who have transfer skill deficits.

Hypothesis 3a: After training, participants will demonstrate higher CATT scores, showing improvement in transfer technique.

Hypothesis 3b: After training, the biomechanical measures described in Specific Aim 2 will show improvement (e.g., lower peak lumbar forces, less trunk flexion and axial rotation, and greater hip and knee flexion).

This study (observational cohort study) will be conducted with a convenience sample of informal caregivers and their care recipients who they transfer. After signing informed consent, all participants will complete a series of baseline questionnaires consisting of their demographic information, health status, quality of life, and pain. After completion of the surveys, several anthropometric measurements of the caregiver will be taken by the research team, including height, weight, length of the foot, shank, thigh, and trunk. Caregiver participants will then be fitted with eight wireless inertial measurement units placed on the their feet, legs, and trunk. They will also be fitted with pressure insoles placed on the inside of their shoes.

Participants will be asked to perform transfers from the wheelchair to two surfaces that they normally transfer to during daily living. A variety of surfaces will be made available for participants to transfer, including a bench, a mat table, a commode, a bed, a chair, a wheelchair and a recreational mobility device (hand cycle). Additional surfaces may be provided at the participant's request. If pairs normally use a transfer assist device to facilitate the transfer, assistive technologies will be made available to them so they can complete the transfers in their usual manner (transfer boards and mechanical lifts will be available on site). The participants will be asked to perform four transfers: 1) moving from the wheelchair to the first selected surface, 2) moving from the first selected surface back to their wheelchair, 3) moving from the wheelchair to the second selected surface and 4) moving from the second selected surface back to the wheelchair. During each transfer, three expert raters will watch each transfer and score the version of the CATT that corresponds with the caregiver's transfer method. Participant dyads will be asked to return to the lab, or the research team will return to them between 24 and 72 hours later to perform the transfer portion of the protocol again. This time frame helps to ensure that repeat administration of the CATT is not affected by rater memories of the first assessment. All raters will independently score each complete and incomplete transfer using the CATT. Raters will also be asked to score the video recordings of the transfers at a later date (at least 1 week after the live recordings).

Outcome measures including surveys, questionnaires, and CATT scores from raters will be collected and managed using an online survey approved by the VA Pittsburgh Healthcare System. During the transfers, three rehabilitation professionals will rate each transfer using the CATT while biomechanical data are collected using a combined IMU/pressure insole system. A webcam integrated into the Ultium IMU/insole system will also record each transfer to facilitate determination of the specific phases of the transfer process.

Participants who were identified as having transfer skill deficits (i.e. scoring a zero on at least two CATT items) in Visit 1 will be asked to participate in a training session during Visit 2 to determine the responsiveness of a CATT-based training protocol. A clinician trained on the CATT will conduct the training session. The clinician will work with the participants to learn and practice the new techniques. They will have an opportunity to practice the techniques until they feel comfortable with performing them. They will be asked to perform a minimum of two transfers to the same surface for the reassessment. A rater who is trained on the CATT but blinded to the biomechanical deficits and training intervention will score the participants using the CATT after training.

Being tested
Transfer Training with clinician
Keywords
caregivers, outcome assessment, health care, wheelchairs, physical medicine and rehabilitation, moving and lifting patients
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transfer Training with clinicianOther

    Participants will undergo transfer training with a clinician who is an expert on assisted transfer techniques if they are found to have skill deficits during the study. After training, a transfer assessment will be conducted to examine if the transfer skills of the caregiver have improved

Study groups in NCT06013878
Study groupRoleWhat they receive
Informal CaregiversInformal caregivers who provide transfer assistance to an individual with a disability
Receives: Other: Transfer Training with clinician
Individuals who use transfer assistanceIndividuals who require assistance with transfers moving from one surface to the other
Receives: Other: Transfer Training with clinician

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Caregiver Assisted Transfer Technique Instrument (CATT) Scores

    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 consists of two versions; one that evaluates manual lift technique (CATT-M) and one that evaluates mechanical lift techniques (CATT-L). It uses three subdomains (set up, transfer performance, and results) to assess caregiver technique during transfers. The investigators expect to see improvements in CATT Scores (higher scores) after intervention with a therapist.

    Measured: Change from baseline and after intervention at 1 week

Secondary outcomes (2)
  1. Change in peak lumbar extension moments

    High lumbar extension moments have been associated with poor lifting technique. Using proper lifting technique has been shown to reduce moments at the L5/S1 joint. The investigators expect to see lower lumbar extension moments after a transfer training intervention with a therapist. Lumbar extension moments will be determined using an inverse dynamics model with data from IMUs and pressure insoles as inputs to the model.

    Measured: Change from baseline and after intervention at 1 week

  2. Change in peak lumbar compression forces

    High Lumbar compression forces at L5/S1 have been associated with low back pain in caregivers who perform lifting tasks. Using proper lifting techniques have been shown to reduce compressive forces at the L5/S1 joint. The investigators expect to see lower lumbar compressive forces after transfer training with a therapist. Lumbar compressive forces will be determined using an inverse dynamics model, with raw data from IMUs and pressure insoles at the model inputs.

    Measured: Change from baseline and after intervention at 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2023
  2. Study start24 Jul 2024
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06013878
Sponsor's protocol ID
F4539-R
Other IDs
1I01RX004539-01A1
Status last verified
Jul 2026
First submitted
22 Aug 2023
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Informal Caregivers and Low Back Pain, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alicia M Koontz, PhD ((412) 383-6596, Alicia.Koontz@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Caregiver Assisted Transfer Technique Instrument (CATT) Scores (time frame: Change from baseline and after intervention at 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in