Physical TherapyNCT06368778
Real-Time Biofeedback on Partial Weightbearing Training
An observational study of Physical Therapy, run by University of Utah at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Physical Therapy
- What is being tested?
- Verbal Advice, Bathroom Scale and Loadsol Biofeedback
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2023to 14 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
Study population: Healthy subjects, aged between 18 and 60 years old able to walk unassisted.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- Verbal Advice, Bathroom Scale, Loadsol Biofeedback
- Keywords
- Biofeedback, Loadsol device, Partial weightbearing training, Standard of care training, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal AdviceOther
Also called Standard physical therapy
The participant will receive verbal instructions following the standard physical therapy.
Bathroom ScaleOther
Also called 20 kg load input with standard physical therapy.
The participant is given a sense of what a 20 kg load feels like using a scale.
Loadsol BiofeedbackDevice
Also called Loadsol device
Average peak force (N) with be measured during partial weightbearing physical therapy routine for 2-minutes using the Loadsol device.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Loadsol Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average peak force (Newtons, (N))
During partial weightbearing physical therapy routine
Measured: During intervention (2-minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start13 Apr 2023
- Primary completion14 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Haller, University of Utah
- Investigators
- Justin Haller, M.D., Principal investigator, University of Utah Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368778
- Sponsor's protocol ID
- 166591
- Status last verified
- Aug 2025
- First submitted
- 11 Apr 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Real-Time Biofeedback on Partial Weightbearing Training: A Comparative Study
- ClinicalTrials.gov ID
- NCT06368778
- Acronym / sponsor ID
- 166591
- Conditions
- Physical Therapy
- Keywords
- Biofeedback, Loadsol device, Partial weightbearing training, Standard of care training, Healthy subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 "Verbal Advice" | – | Other: Verbal AdviceThe 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. |
| Group 2 "Bathroom Scale" | – | Other: Bathroom ScaleIn 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. |
| Group 3 "Biofeedback" | – | Device: Loadsol BiofeedbackIn 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Healthy subjects, aged between 18 and 60 years old able to walk unassisted.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verbal AdviceAlso: Standard physical therapyThe participant will receive verbal instructions following the standard physical therapy. | Other | Group 1 "Verbal Advice" |
| Bathroom ScaleAlso: 20 kg load input with standard physical therapy.The participant is given a sense of what a 20 kg load feels like using a scale. | Other | Group 2 "Bathroom Scale" |
| Loadsol BiofeedbackAlso: Loadsol deviceAverage peak force (N) with be measured during partial weightbearing physical therapy routine for 2-minutes using the Loadsol device. | Device | Group 3 "Biofeedback" |
Primary outcome
Average peak force (Newtons, (N))
Time frame: During intervention (2-minutes)
During partial weightbearing physical therapy routine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Haller, M.D. principal investigator
University of Utah Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Therapy, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average peak force (Newtons, (N)) (time frame: During intervention (2-minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.