Real-Time Biofeedback on Partial Weightbearing Training

NCT06368778 | Completed DMC

• 1 other identifier: 166591
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Biofeedback; Loadsol device; Partial weightbearing training; Standard of care training; Healthy subjects

Outcome Measures

Primary Outcomes (1)

• Average peak force (Newtons, (N))

  During partial weightbearing physical therapy routine

  During intervention (2-minutes)

Study Arms (3)

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

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

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

Interventions

Verbal Advice OTHER

The participant will receive verbal instructions following the standard physical therapy.

Also known as: Standard physical therapy

Group 1 "Verbal Advice"

Bathroom Scale OTHER

The participant is given a sense of what a 20 kg load feels like using a scale.

Also known as: 20 kg load input with standard physical therapy.

Group 2 "Bathroom Scale"

Loadsol Biofeedback DEVICE

Average peak force (N) with be measured during partial weightbearing physical therapy routine for 2-minutes using the Loadsol device.

Also known as: Loadsol device

Group 3 "Biofeedback"

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

Study Officials

• Justin Haller, M.D.

  University of Utah Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: April 13, 2023
• Primary Completion: July 14, 2025
• Study Completion: July 14, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)