SurgeryNCT06426576
Load Limits After Orthopaedic Surgery: Biofeedback vs. Conventional Method (AppPWB)
A study testing Standard one-off instruction using a scale and Plantar pressure insoles in people with Surgery, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim of this single-centre prospective randomized-controlled clinical trial is to assess whether patients adhere to prescribed weight bearing limits after surgical orthopaedic or traumatological interventions more accurately after instruction using a biofeedback method than using the standard method. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Standard one-off instruction using a scale and Plantar pressure insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2024to 30 Nov 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with prescribed partial weight bearing (joint-independent) for at least 2 weeks
- Unilateral injury of the lower extremity
- Having their own smartphone
- Age 18 years and older
Who cannot join
- Patients with prescribed full weight bearing
- Patients with prescribed complete unloading
- Patients with prescribed self-selected loading "according to pain"
- Bilateral injuries of lower extremities
- Upper extremity injuries precluding the use of crutches
- Use of walking aids prior to injury
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- Neurological conditions affecting gait
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.,
- Previous enrolment in a clinical trial
- Body mass > 135 kg
- Age under 18 years
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Orthopaedics and Traumatology, University Hospital Basel, Bethesda Spital Basel
Basel, Canton of Basel-City, 4052
About this study
Official title: Application of Load Limits After Orthopaedic Surgery With Biofeedback-based Instructions Compared to a Conventional Method
The aim of this single-centre prospective randomized-controlled clinical trial is to assess whether patients adhere to prescribed weight bearing limits after surgical orthopaedic or traumatological interventions more accurately after instruction using a biofeedback method than using the standard method.
Read the detailed description
Partial weight bearing, commonly prescribed post-surgery in orthopaedics and traumatology, aims to stimulate healing while preventing overloading. Partial weight bearing refers to that the patient is only allowed to put 10 to 50% of their body weight on the affected limb.
The most commonly used method for instructing partial weight bearing with the patient is using a personal scale. This means that the patient can only exercise in a static position and the perceived load must be transferred to dynamic activities of daily living without further feedback. Previous reports indicate that patients often struggle to adhere to prescribed partial weight-bearing limits, frequently exceeding the specified load by 100% or more. However, when additional feedback was incorporated into training, approximately 90% of subjects successfully adhered to the partial load.
Portable or wearable measuring systems, such as pressure-sensitive insoles, offer feedback during dynamic tasks, facilitating a smoother transition to daily activities. Unlike the standard one-time instruction using a scale, these systems provide repeated feedback at each step, promoting a higher frequency of exercises. This aids patients in developing a better sense of the correct load.
This single-centre prospective randomized-controlled clinical trial aims to investigate the effectiveness of pressure insoles connected to a smartphone via Bluetooth and operated using an app in improving partial weight bearing adherence. The insoles provide direct feedback through acoustic and visual signals if the affected leg is overloaded, possibly leading to a lower proportion of steps over the load limit compared to those without feedback. Participants are randomized into either the intervention group (dynamic condition - plantar pressure insoles) or the control group (static condition - standard one-off instruction using a scale).
The primary objective is to determine whether the proportion of steps exceeding the weight bearing limit is lower in the intervention group compared to the control group 2 weeks after surgery. Secondary objectives include assessing subjective ratings of the permitted load, perceived pain, and mobility. Additionally, the trial hypothesizes that patients using the insoles can estimate applied load more accurately. The intervention group will also provide feedback on the usability of the app and insoles.
The results of this trial will contribute to enhancing postoperative treatment of patients undergoing orthopaedic surgery, thereby improving treatment outcomes and optimizing therapy regimens.
- Conditions
- Surgery
- Being tested
- Standard one-off instruction using a scale, Plantar pressure insoles
- Keywords
- Orthopaedic surgery, Partial weight bearing, Portable measurement systems, Plantar pressure insoles, Biofeedback function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard one-off instruction using a scaleOther
The permitted weight is demonstrated to the patient once using a scale in the static position. The patient repeatedly places the foot with the permitted weight on a scale in order to develop a feeling for the load. After this exercise in the static position, the patient applies the perceived load to dynamic activities of daily living without receiving any feedback.
The instruction is given by a trained physiotherapist. Simultaneously with the instruction, the effective weight applied on the leg will be measured using instrumented insoles without any feedback.
Plantar pressure insolesDevice
The insoles are used in both static and dynamic conditions such as walking straight along the hallway or walking stairs if applicable. Initial instruction is given by a trained physiotherapist and will be continuously applied at home using the smartphone app for 5 out of 7 days per week during the first 2 weeks after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | The control group receives instructions on partial weight bearing using the standard method. Receives: Other: Standard one-off instruction using a scale |
| Intervention group | Experimental | The intervention group receives instructions on partial weight bearing using a plantar pressure sole inserted into the shoe that measures the force/weight applied to the foot and indicates the applied weight to the patient both visually and acoustically via a smartphone app. Receives: Device: Plantar pressure insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of steps (%) over of the prescribed weight bearing limit on the injured leg while walking, assessed with the instrumented insoles.
After 2 weeks of continuous use of the feedback-providing insoles by the intervention group, the adherence to load limits is evaluated at the follow-up visit. This assessment aims to determine if the intervention group adheres better to the prescribed weight-bearing limits compared to the control group, which did not receive feedback during this period. Both groups have the proportion of steps (%) exceeding the prescribed weight-bearing limit on the injured leg while walking assessed using instrumented insoles.
Measured: At 2 weeks post-surgery
Secondary outcomes (6)
Assessment of perceived pain
To assess the pain level, the numeric analog scale is used. Patients are asked to rate their pain on a scale from 0 to 10, where 0 indicates no pain while 10 indicates the worst possible pain.
Measured: Baseline and at 2 weeks post-surgery
Assessment of physical activity
To assess the physical activity, the UCLA Activity Scale(UCLA) is used The UCLA Activity Scale consists of questions related to different activities, and patients rate their ability to perform each activity on a scale from 1 to 10, with higher scores indicating greater activity levels.
Measured: Baseline and at 2 weeks post-surgery
Assessment of mobility
To assess the mobility, the Life Space Questionnaire and Parker Mobility Score are used. The former asks respondents to report on their frequency of movement and the distance traveled within various zones, such as within their home, neighborhood, and beyond. The latter evaluates an individual's ability to perform three basic mobility tasks. A score is given to each activity on a 4 point scale (0 - not at all, 1 - assistance of one person, 2 - with an aid, 3 - no difficulty and no aid) and then combined to provide a final score between 0 and 9, where 9 is independent with no aid in all three activities, and 0 is not able to carry out any of the activities.
Measured: Baseline and at 2 weeks post-surgery
Assessment of the quality of life
The health-related quality of life is assessed using the EuroQol-5 Dimensions (EQ-5D). It is a standardized questionnaire used to assess an individual's health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has three levels of severity (no problems, some problems, extreme problems), allowing for the classification of 243 unique health states.
Measured: Baseline and at 2 weeks post-surgery
Assessment of perceived load applied
Patients are asked to estimate the applied load.
Measured: At 2 weeks post-surgery
Assessment of the usability of the planar pressure insoles (intervention group only)
The intervention group is asked to provide feedback on the usability of the app and insoles using a questionnaire.
Measured: At 2 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start1 Mar 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlene Mauch, Dr., Principal investigator, Department of Orthopaedics and Traumatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426576
- Sponsor's protocol ID
- 2024-00106; mu24Mauch
- Status last verified
- Mar 2025
- First submitted
- 17 May 2024
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Load Limits After Orthopaedic Surgery With Biofeedback-based Instructions Compared to a Conventional Method
- ClinicalTrials.gov ID
- NCT06426576
- Acronym / sponsor ID
- 2024-00106; mu24Mauch
- Conditions
- Surgery
- Keywords
- Orthopaedic surgery, Partial weight bearing, Portable measurement systems, Plantar pressure insoles, Biofeedback function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 23 May 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 aim of this single-centre prospective randomized-controlled clinical trial is to assess whether patients adhere to prescribed weight bearing limits after surgical orthopaedic or traumatological interventions more accurately after instruction using a biofeedback method than using the standard method.
Detailed description
Partial weight bearing, commonly prescribed post-surgery in orthopaedics and traumatology, aims to stimulate healing while preventing overloading. Partial weight bearing refers to that the patient is only allowed to put 10 to 50% of their body weight on the affected limb.
The most commonly used method for instructing partial weight bearing with the patient is using a personal scale. This means that the patient can only exercise in a static position and the perceived load must be transferred to dynamic activities of daily living without further feedback. Previous reports indicate that patients often struggle to adhere to prescribed partial weight-bearing limits, frequently exceeding the specified load by 100% or more. However, when additional feedback was incorporated into training, approximately 90% of subjects successfully adhered to the partial load.
Portable or wearable measuring systems, such as pressure-sensitive insoles, offer feedback during dynamic tasks, facilitating a smoother transition to daily activities. Unlike the standard one-time instruction using a scale, these systems provide repeated feedback at each step, promoting a higher frequency of exercises. This aids patients in developing a better sense of the correct load.
This single-centre prospective randomized-controlled clinical trial aims to investigate the effectiveness of pressure insoles connected to a smartphone via Bluetooth and operated using an app in improving partial weight bearing adherence. The insoles provide direct feedback through acoustic and visual signals if the affected leg is overloaded, possibly leading to a lower proportion of steps over the load limit compared to those without feedback. Participants are randomized into either the intervention group (dynamic condition - plantar pressure insoles) or the control group (static condition - standard one-off instruction using a scale).
The primary objective is to determine whether the proportion of steps exceeding the weight bearing limit is lower in the intervention group compared to the control group 2 weeks after surgery. Secondary objectives include assessing subjective ratings of the permitted load, perceived pain, and mobility. Additionally, the trial hypothesizes that patients using the insoles can estimate applied load more accurately. The intervention group will also provide feedback on the usability of the app and insoles.
The results of this trial will contribute to enhancing postoperative treatment of patients undergoing orthopaedic surgery, thereby improving treatment outcomes and optimizing therapy regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Standard one-off instruction using a scaleThe control group receives instructions on partial weight bearing using the standard method. |
| Intervention group | Experimental | Device: Plantar pressure insolesThe intervention group receives instructions on partial weight bearing using a plantar pressure sole inserted into the shoe that measures the force/weight applied to the foot and indicates the applied weight to the patient both visually and acoustically via a smartphone app. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with prescribed partial weight bearing (joint-independent) for at least 2 weeks
- Unilateral injury of the lower extremity
- Having their own smartphone
- Age 18 years and older
Key exclusion criteria (11 listed)
- Patients with prescribed full weight bearing
- Patients with prescribed complete unloading
- Patients with prescribed self-selected loading "according to pain"
- Bilateral injuries of lower extremities
- Upper extremity injuries precluding the use of crutches
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 |
|---|---|---|
| Standard one-off instruction using a scaleThe permitted weight is demonstrated to the patient once using a scale in the static position. The patient repeatedly places the foot with the permitted weight on a scale in order to develop a feeling for the load. After this exercise in the static position, the patient applies the perceived load to dynamic activities of daily living without receiving any feedback. The instruction is given by a trained physiotherapist. Simultaneously with the instruction, the effective weight applied on the leg will be measured using instrumented insoles without any feedback. | Other | Control group |
| Plantar pressure insolesThe insoles are used in both static and dynamic conditions such as walking straight along the hallway or walking stairs if applicable. Initial instruction is given by a trained physiotherapist and will be continuously applied at home using the smartphone app for 5 out of 7 days per week during the first 2 weeks after surgery. | Device | Intervention group |
Primary outcome
Proportion of steps (%) over of the prescribed weight bearing limit on the injured leg while walking, assessed with the instrumented insoles.
Time frame: At 2 weeks post-surgery
After 2 weeks of continuous use of the feedback-providing insoles by the intervention group, the adherence to load limits is evaluated at the follow-up visit. This assessment aims to determine if the intervention group adheres better to the prescribed weight-bearing limits compared to the control group, which did not receive feedback during this period. Both groups have the proportion of steps (%) exceeding the prescribed weight-bearing limit on the injured leg while walking assessed using instrumented insoles.
6 secondary outcomes
Assessment of perceived pain
Time frame: Baseline and at 2 weeks post-surgery
Assessment of physical activity
Time frame: Baseline and at 2 weeks post-surgery
Assessment of mobility
Time frame: Baseline and at 2 weeks post-surgery
Assessment of the quality of life
Time frame: Baseline and at 2 weeks post-surgery
Assessment of perceived load applied
Time frame: At 2 weeks post-surgery
Assessment of the usability of the planar pressure insoles (intervention group only)
Time frame: At 2 weeks post-surgery
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 10 Mar 2025.
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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.
Marlene Mauch, Dr. principal investigator
Department of Orthopaedics and Traumatology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard one-off instruction using a scale and Plantar pressure insoles in people with Surgery, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 4 inclusion and 11 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 10 Mar 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 Switzerland. 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?
Proportion of steps (%) over of the prescribed weight bearing limit on the injured leg while walking, assessed with the instrumented insoles. (time frame: At 2 weeks post-surgery). 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 10 Mar 2025.