Real-Time Biofeedback on Partial Weightbearing Training

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

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.

Study Overview

• Status: Completed
• Conditions: Physical Therapy
• Intervention / Treatment: Other: Verbal Advice; Other: Bathroom Scale; Device: Loadsol Biofeedback

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah Orthopaedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects, aged between 18 and 60 years old able to walk unassisted.

Description

Inclusion Criteria:

• Aged between 18 and 60 years old.
• Healthy and able to walk unassisted.
• No cognitive impairments.
• Willing to participate in the study.
• Capable of using crutches.
• English- speaking.

Exclusion Criteria:

• Unwilling to participate in the study.
• Sensor incompatibility: shoe sizes smaller than EU 36 (Womens size 4, Men's size 6) or larger than EU 44 (Women's size 13, Men's size 11).
• Non-English speaking.
• Pregnant women must not take part in this study, due to a higher chance of injury in the unlikely event of a fall.
• >7 on Six-Item Cognitive Impairment Test

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 "Verbal Advice"; The participant will receive verbal instructions following the standard of care physical therapy. A member of the study team will observe and provide comments on the participant's exercises.	Other: Verbal Advice; The participant will receive verbal instructions following the standard physical therapy.; Other Names: Standard physical therapy
Group 2 "Bathroom Scale"; In this group, the participant is given a sense of what a 20 kg load feels like using a scale. Subsequently, the same exercises as in Group 1 will be conducted.	Other: Bathroom Scale; The participant is given a sense of what a 20 kg load feels like using a scale.; Other Names: 20 kg load input with standard physical therapy.
Group 3 "Biofeedback"; In this group, the biofeedback function of the sensor insoles is activated. This feature provides both visual (a bar graph on the iPad) and auditory feedback (an audible signal when the load exceeds 20 kg). Through this feedback, the participant is expected to develop an understanding of partial weight-bearing.	Device: Loadsol Biofeedback; Average peak force (N) with be measured during partial weightbearing physical therapy routine for 2-minutes using the Loadsol device.; Other Names: Loadsol device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average peak force (Newtons, (N))	During partial weightbearing physical therapy routine	During intervention (2-minutes)

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Justin Haller, M.D., University of Utah Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2023
• Primary Completion (Actual): July 14, 2025
• Study Completion (Actual): July 14, 2025

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Healthy subjects; Biofeedback; Loadsol device; Partial weightbearing training; Standard of care training
• Other Study ID Numbers: 166591

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No