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ID
Source
Brief title
Health condition
Anterior cruciate ligament reconstruction
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Percentage of incorrect steps: This parameter will be used to evaluate the difference in fractions of incorrect steps, with or without the use of the ABF device.
2. Time interval between incorrect steps (exeeding either the maximum or minimum allowed weight): This parameter will be used to indicate the learning curve involved in adapting to the use of an ABF device.
Secondary outcome
An interview will be conducted after the seccond session, giving an indication of user acceptance of the auditory biofeedback training in general and the tested ABF device.
Background summary
After surgery or injury of the lower extremity, partial weight bearing (PWB) is often instructed to the patient. However it is very difficult for patients to comply with given PWB instructions. Currently available methods to improve a patient's PWB compliance are either insufficient or too expensive. The cheap and portable Auditory biofeedback device tested in this study, can give feedback about a patient's weight bearing during walking. It will be investigated whether it is feasible to improve a patient's PWB compliance with help of the ABF device. In case feedback from the ABF device can indeed improve a patient's PWB compliance, the device can also be used at home, due to the low costs of the device. Then a large scale RCT can be performed to investigate the effect of PWB after surgery on the rehabilitation process. All future patients to whom PWB is instructed, will benefit from this knowledge.
Study objective
Use of the auditory biofeedback device, will improve partial weight bearing compliance
Study design
Two weeks after surgery the first session will be conducted.
Three weeks after surgery the second session will be conducted.
Intervention
In this study an auditory biofeedback (ABF) device, giving feedback about partial weight bearing (PWB) to the paient will be tested. The device consists out of a measurement insole embedded in a sandal. Via a bluetooth connection this insole is connected to a smartphone. When the patient applies too much or too little force on his/her limb an auditory signal is given by the smartphone. To test whether an ABF device can improve a patient's PWB complicance 2 groups of 10 patients will be formed. the "feeback group" will receive feedback by an auditory signal from the ABF device. The control group will wear the ABF device as well but will not receive feedback from it. All patients will enroll in two sessions to test repeatability.
Iris Bokkes
A. Deusinglaan 1, Building 3215, room 1105B
Groningen 9713 AV
The Netherlands
i.bokkes@student.rug.nl
Iris Bokkes
A. Deusinglaan 1, Building 3215, room 1105B
Groningen 9713 AV
The Netherlands
i.bokkes@student.rug.nl
Inclusion criteria
- Patients recovering from ACL reconstruction
- Younger than 65 years of age
- Able to walk with crutches
- Able to speak Dutch
Exclusion criteria
- Significant orthopeadic disturbances or pain
- serious co-morbidities
- Clinically significant hearing problems
- Clinically significant neurological problems
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5295 |
| NTR-old | NTR5404 |
| Other | METC number: METc 2015/141 : ABR Number: 52008 |