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van CCT (UK)

van CCT (UK)

Use of auditory feedback to improve a patients compliance with partial weight bearing

- candidate number21932
- NTR NumberNTR5404
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-apr-2015
- Secondary IDsABR Number: 52008 METC number: METc 2015/141
- Public TitleUse of auditory feedback to improve a patients compliance with partial weight bearing
- Scientific TitleUse of an Auditory BioFeedback system to improve a patient's Partial Weight Bearing compliance: A feasibility study
- ACRONYMImproving partial weight bearing compliance using an auditory biofeedback device
- hypothesisUse of the auditory biofeedback device, will improve partial weight bearing compliance
- Healt Condition(s) or Problem(s) studiedAnterior cruciate ligament (ACL) injury
- 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
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-mei-2015
- planned closingdate1-jul-2015
- Target number of participants20
- InterventionsIn 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.
- Primary outcome1. 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 outcomeAn 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.
- TimepointsTwo weeks after surgery the first session will be conducted.
Three weeks after surgery the second session will be conducted.
- Trial web site
- statusplanned
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summaryAfter 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.
- Main changes (audit trail)
- RECORD9-apr-2015 - 21-okt-2015

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