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Real-Time Biofeedback on Partial Weightbearing Training

NCT06368778 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-08-12

No results posted yet for this study

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.

Conditions

  • Physical Therapy

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Justin Haller, M.D. · University of Utah Orthopaedics

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-13
Primary Completion
2025-07-14
Completion
2025-07-14

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06368778 on ClinicalTrials.gov