Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06368778 |
| Other study ID # |
166591 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 13, 2023 |
| Est. completion date |
April 2025 |
Study information
| Verified date |
April 2024 |
| Source |
University of Utah |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to investigate the effectiveness of a biofeedback device
(Loadsol) in training healthy subjects to comply with partial weightbearing, and to compare
its outcomes with the standard of care training. Partial weightbearing is an essential
component of rehabilitation and recovery for many orthopedic patients, yet it remains
challenging for individuals to accurately gauge their weightbearing restrictions without
proper guidance and feedback.
The primary objective of the study is to determine whether the use of the biofeedback device
(Loadsol) can reduce the time it takes for healthy subjects to learn and comply with partial
weightbearing, compared to traditional training methods. The Loadsol device provides
real-time auditory feedback on the individual's weightbearing status, potentially enhancing
the learning process and adherence to weightbearing restrictions.
Secondary objectives of the study include:
Assessing the compliance of subjects with weightbearing restrictions in both the biofeedback
and standard of care training groups, and comparing the results to identify any significant
differences in adherence to the prescribed weightbearing limitations.
Evaluating subject satisfaction with the training methods, as measured through questionnaires
and the use of Patient-Reported Outcomes Measurement Information System (PROMIS) tools. This
evaluation will help determine if the biofeedback device (Loadsol) leads to higher levels of
satisfaction among subjects compared to the standard of care training.
By examining these objectives, this study aims to provide valuable insights into the
potential benefits of using a biofeedback device in partial weightbearing training, and to
establish whether its implementation can lead to improved outcomes in learning, compliance,
and overall patient satisfaction.
Description:
Partial weightbearing is an essential aspect of rehabilitation for many orthopedic patients,
as it promotes healing and helps prevent complications after injury or surgery.
Traditionally, patients receive instructions and guidance from healthcare professionals to
achieve appropriate weightbearing levels. However, accurately gauging one's weightbearing
status can be challenging without proper feedback.
Recent literature has investigated the use of biofeedback devices in training patients for
partial weightbearing, demonstrating their potential in improving compliance and learning.
However, to date, no studies have directly compared the effectiveness of biofeedback devices,
such as Loadsol, with the standard of care (SOC) in terms of the time required for patients
to learn and comply with partial weightbearing restrictions.
Furthermore, existing research has focused on orthopedic patients, who may be subject to
various confounding factors such as pain, different fracture patterns, and surgical
interventions. No studies have yet explored the use of biofeedback devices in training
healthy subjects for partial weightbearing, which could provide valuable insights without the
influence of these confounders.
In addition, the Loadsol device has been compared to other devices, such as treadmills and
force plates, in terms of measurement quality. Studies have suggested that the Loadsol device
provides comparable results, supporting its reliability and potential effectiveness in
partial weightbearing training.
This study aims to fill the gap in the literature by comparing the Loadsol biofeedback device
with the standard of care in training healthy subjects for partial weightbearing. By
evaluating the time taken to learn and comply with weightbearing restrictions, compliance
with weightbearing limitations, and subject satisfaction, this research seeks to provide a
more comprehensive understanding of the potential benefits of using a biofeedback device in
partial weightbearing training.
