NCT06368778

Real-Time Biofeedback on Partial Weightbearing Training

The Impact of Real-Time Biofeedback on Partial Weightbearing Training: A Comparative Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Physical Therapy

Interventions

Type	Name	Description
OTHER	Verbal Advice	The participant will receive verbal instructions following the standard physical therapy.
OTHER	Bathroom Scale	The participant is given a sense of what a 20 kg load feels like using a scale.
DEVICE	Loadsol Biofeedback	Average peak force (N) with be measured during partial weightbearing physical therapy routine for 2-minutes using the Loadsol device.

Timeline

• Start date: 2023-04-13
• Primary completion: 2025-07-14
• Completion: 2025-07-14
• First posted: 2024-04-16
• Last updated: 2025-08-12

Locations

1 site across 1 country: United States