Total Hip ReplacementNCT04268082
Insole-based Visual Biofeedback for Weight-bearing in Total Hip Replacement
A study testing Visual biofeedback with the use of sensorized insoles and Standard rehabilitation based on physiotherapist's verbal instructions in people with Total Hip Replacement and Visual Biofeedback, run by University of Pavia at 1 site in Italy.
Trial summary
The study investigates the effects of visual biofeedback, based on a sensorized system for the dynamic evaluation of the plantar pressure versus rehabilitation with traditional verbal instructions of the physiotherapist, on weight bearing distribution in patients who underwent first total hip replacement. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Total Hip Replacement, Visual Biofeedback, Weight Bearing
- What is being tested?
- Visual biofeedback with the use of sensorized insoles and Standard rehabilitation based on physiotherapist's verbal instructions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2018to 31 Jul 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 75 ≤ years of age,
- absence of conditions that could alter the gait cycle,
- absence of conditions that could reduce or alter visual ability,
- etherometry ≤ 0.5 mm
- Mini-Mental State Examination (MMSE) score ≥ 24.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Insole-based Visual Biofeedback on Weight-bearing in Patients Undergoing Total Hip Replacement. A Randomised Controlled Trial.
The study investigates the effects of visual biofeedback, based on a sensorized system for the dynamic evaluation of the plantar pressure versus rehabilitation with traditional verbal instructions of the physiotherapist, on weight bearing distribution in patients who underwent first total hip replacement. The study is a randomized controlled trial, with parallel groups, without blinding.
Read the detailed description
Forty patients, who underwent first total hip replacement surgery were enrolled and divided into two groups on second postoperative day. Experimental group followed the training wearing sensorized insoles that provided plantar pressures and shift of foot center of pressure images on three monitors. Control Group followed verbal instructions of physiotherapist during training. From 4th to 10th postoperative day both groups followed the same rehabilitation program including exercises to restore correct weight bearing.
- Conditions
- Total Hip Replacement, Visual Biofeedback, Weight Bearing
- Being tested
- Visual biofeedback with the use of sensorized insoles, Standard rehabilitation based on physiotherapist's verbal instructions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual biofeedback with the use of sensorized insolesDevice
Between the 4th and the 10th day post surgery, both groups performed the same rehabilitation protocol. The experimental group was re-educated to the correct gait dynamics by wearing the sensorized insoles and by using a specific software's graphical interface as a visual biofeedback.
Standard rehabilitation based on physiotherapist's verbal instructionsOther
Between the 4th and the 10th day post surgery, both groups performed the same rehabilitation protocol.The Control group did not wear the insoles, but it carried out the rehabilitation programme under the physiotherapist supervision and with his verbal feedbacks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The Experimental Group followed the training wearing sensorized insoles that provided plantar pressures and shift of foot center of pressure images reported on monitors. Receives: Device: Visual biofeedback with the use of sensorized insoles |
| Control Group | Active comparator | The Control Group followed verbal instructions of physiotherapist during training. Receives: Other: Standard rehabilitation based on physiotherapist's verbal instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Bearing Absolute difference between lower limbs (ΔWBA)
Weight Bearing Absolute difference between lower limbs in kg as reported by the stabilometric platform
Measured: between the 4th and the 10th day post surgery
Weight Bearing Percentage difference between lower limbs (ΔWBP)
Weight Bearing Percentage difference between lower limbs in % as reported by the stabilometric platform
Measured: between the 4th and the 10th day post surgery
Weight Bearing Percentage Healthy limb (WBPH)
Weight Bearing Percentage Healthy limb in % as reported by the stabilometric platform
Measured: between the 4th and the 10th day post surgery
Weight Bearing Percentage Surgical limb (WBPS)
Weight Bearing Percentage Surgical limb in % as reported by the stabilometric platform
Measured: between the 4th and the 10th day post surgery
Weight Bearing Absolute Healthy limb (WBAH)
Weight Bearing Absolute Healthy limb in kg as reported by the stabilometric platform
Measured: between the 4th and the 10th day post surgery
Weight Bearing Absolute Surgical limb (WBAS)
Weight Bearing Absolute Surgical limb in kg as reported by the stabilometric platform
Measured: between the 4th and the 10th day post surgery
Secondary outcomes (8)
Mid Step Length Healthy limb (MSLH)
Mid Step Length Healthy limb in mm as reported by the stabilometric platform
Measured: between the 4th and the 10th day post surgery
Mid Step Length Surgical limb (MSLS)
Mid Step Length Surgical limb in mm as reported by the stabilometric platform
Measured: between the 4th and the 10th day post surgery
Sway Healthy limb (SWH)
Sway Healthy limb in mm as reported by the stabilometric platform
Measured: between the 4th and the 10th day post surgery
Sway Surgical limb (SWS)
Sway Surgical limb in mm as reported by the stabilometric platform
Measured: between the 4th and the 10th day post surgery
Double Support Time (DST)
Double Support Time in ms as reported by the stabilometric platform
Measured: between the 4th and the 10th day post surgery
Numeric Rating Scale (NRS)
Numeric Rating Scale
Measured: between the 4th and the 10th day post surgery
Six Minutes Walking Test (6MWT)
Six Minutes Walking Test in m
Measured: between the 4th and the 10th day post surgery
World Health Organization Quality of Life Questionnaire (WHOQOL)
World Health Organization Quality of Life Questionnaire
Measured: between the 4th and the 10th day post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start1 Apr 2018
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ReplacementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Marin, University of Pavia
- Investigators
- Luca Marin, PhD, Principal investigator, University of Pavia, Pavia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268082
- Sponsor's protocol ID
- 20180036031
- Status last verified
- Feb 2020
- First submitted
- 6 Feb 2020
- Last updated
- 13 Feb 2020
- Results posted
- No
- 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 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Insole-based Visual Biofeedback on Weight-bearing in Patients Undergoing Total Hip Replacement. A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT04268082
- Acronym / sponsor ID
- 20180036031
- Conditions
- Total Hip Replacement, Visual Biofeedback, Weight Bearing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 13 Feb 2020 (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 study investigates the effects of visual biofeedback, based on a sensorized system for the dynamic evaluation of the plantar pressure versus rehabilitation with traditional verbal instructions of the physiotherapist, on weight bearing distribution in patients who underwent first total hip replacement. The study is a randomized controlled trial, with parallel groups, without blinding.
Detailed description
Forty patients, who underwent first total hip replacement surgery were enrolled and divided into two groups on second postoperative day. Experimental group followed the training wearing sensorized insoles that provided plantar pressures and shift of foot center of pressure images on three monitors. Control Group followed verbal instructions of physiotherapist during training. From 4th to 10th postoperative day both groups followed the same rehabilitation program including exercises to restore correct weight bearing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Visual biofeedback with the use of sensorized insolesThe Experimental Group followed the training wearing sensorized insoles that provided plantar pressures and shift of foot center of pressure images reported on monitors. |
| Control Group | Active comparator | Other: Standard rehabilitation based on physiotherapist's verbal instructionsThe Control Group followed verbal instructions of physiotherapist during training. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 75 ≤ years of age,
- absence of conditions that could alter the gait cycle,
- absence of conditions that could reduce or alter visual ability,
- etherometry ≤ 0.5 mm
- Mini-Mental State Examination (MMSE) score ≥ 24.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Visual biofeedback with the use of sensorized insolesBetween the 4th and the 10th day post surgery, both groups performed the same rehabilitation protocol. The experimental group was re-educated to the correct gait dynamics by wearing the sensorized insoles and by using a specific software's graphical interface as a visual biofeedback. | Device | Experimental Group |
| Standard rehabilitation based on physiotherapist's verbal instructionsBetween the 4th and the 10th day post surgery, both groups performed the same rehabilitation protocol.The Control group did not wear the insoles, but it carried out the rehabilitation programme under the physiotherapist supervision and with his verbal feedbacks. | Other | Control Group |
Primary outcome
Weight Bearing Absolute difference between lower limbs (ΔWBA)
Time frame: between the 4th and the 10th day post surgery
Weight Bearing Absolute difference between lower limbs in kg as reported by the stabilometric platform
Weight Bearing Percentage difference between lower limbs (ΔWBP)
Time frame: between the 4th and the 10th day post surgery
Weight Bearing Percentage difference between lower limbs in % as reported by the stabilometric platform
Weight Bearing Percentage Healthy limb (WBPH)
Time frame: between the 4th and the 10th day post surgery
Weight Bearing Percentage Healthy limb in % as reported by the stabilometric platform
Weight Bearing Percentage Surgical limb (WBPS)
Time frame: between the 4th and the 10th day post surgery
Weight Bearing Percentage Surgical limb in % as reported by the stabilometric platform
Weight Bearing Absolute Healthy limb (WBAH)
Time frame: between the 4th and the 10th day post surgery
Weight Bearing Absolute Healthy limb in kg as reported by the stabilometric platform
Weight Bearing Absolute Surgical limb (WBAS)
Time frame: between the 4th and the 10th day post surgery
Weight Bearing Absolute Surgical limb in kg as reported by the stabilometric platform
8 secondary outcomes
Mid Step Length Healthy limb (MSLH)
Time frame: between the 4th and the 10th day post surgery
Mid Step Length Surgical limb (MSLS)
Time frame: between the 4th and the 10th day post surgery
Sway Healthy limb (SWH)
Time frame: between the 4th and the 10th day post surgery
Sway Surgical limb (SWS)
Time frame: between the 4th and the 10th day post surgery
Double Support Time (DST)
Time frame: between the 4th and the 10th day post surgery
Numeric Rating Scale (NRS)
Time frame: between the 4th and the 10th day post surgery
Six Minutes Walking Test (6MWT)
Time frame: between the 4th and the 10th day post surgery
World Health Organization Quality of Life Questionnaire (WHOQOL)
Time frame: between the 4th and the 10th day 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 13 Feb 2020.
- Individual participant dataSharing planned: No
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Developmental Dysplasia of the Hip, Acetabular Bone Loss
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Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
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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.
Luca Marin, PhD principal investigator
University of Pavia, Pavia, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual biofeedback with the use of sensorized insoles and Standard rehabilitation based on physiotherapist's verbal instructions in people with Total Hip Replacement and Visual Biofeedback, run by University of Pavia at 1 site in Italy.
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 5 inclusion and 1 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 13 Feb 2020. 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 Italy. 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?
Weight Bearing Absolute difference between lower limbs (ΔWBA) (time frame: between the 4th and the 10th day post surgery). The study lists 6 primary outcomes in all. 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 13 Feb 2020.