- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06013878
Biomechanical Validation of the CATT
Biomechanical Validation of the Caregiver Assisted Transfer Technique Instrument
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alicia M Koontz, PhD
- Phone Number: (412) 383-6596
- Email: Alicia.Koontz@va.gov
Study Contact Backup
- Name: Nikitha Deepak, MS BS
- Phone Number: (412) 822-3669
- Email: nikitha.deepak@va.gov
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15240
- Recruiting
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
-
Contact:
- Nikitha Deepak, MS BS
- Phone Number: (412) 822-3669
- Email: nikitha.deepak@va.gov
-
Contact:
- Alicia M Koontz, PhD
- Phone Number: 412-383-6596
- Email: Alicia.Koontz@va.gov
-
Principal Investigator:
- Alicia M Koontz, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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:
- at least 18 years old
- 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:
- at least 18 years old,
- has a physical disability diagnosis for at least one year
- requires assistance with transfers
- 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:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Informal Caregivers
Informal caregivers who provide transfer assistance to an individual with a disability
|
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
|
|
Individuals who use transfer assistance
Individuals who require assistance with transfers moving from one surface to the other
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Caregiver Assisted Transfer Technique Instrument (CATT) Scores
Time Frame: Change from baseline and after intervention at 1 week
|
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.
|
Change from baseline and after intervention at 1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in peak lumbar extension moments
Time Frame: Change from baseline and after intervention at 1 week
|
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.
|
Change from baseline and after intervention at 1 week
|
|
Change in peak lumbar compression forces
Time Frame: Change from baseline and after intervention at 1 week
|
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.
|
Change from baseline and after intervention at 1 week
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alicia M Koontz, PhD, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- F4539-R
- 1I01RX004539-01A1 (U.S. NIH Grant/Contract: VA Rehabilitation Research and Development Service)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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