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Insole-based Visual Biofeedback for Weight-bearing in Total Hip Replacement

The Effects of Insole-based Visual Biofeedback on Weight-bearing in Patients Undergoing Total Hip Replacement. A Randomised Controlled Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04268082
Enrollment
40
Registered
2020-02-13
Start date
2018-04-01
Completion date
2018-07-31
Last updated
2020-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Hip Replacement, Visual Biofeedback, Weight Bearing

Brief 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. 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.

Interventions

DEVICEVisual biofeedback with the use of sensorized insoles

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.

OTHERStandard rehabilitation based on physiotherapist's verbal instructions

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.

Sponsors

University of Pavia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Weight Bearing Absolute difference between lower limbs (ΔWBA)between the 4th and the 10th day post surgeryWeight Bearing Absolute difference between lower limbs in kg as reported by the stabilometric platform
Weight Bearing Percentage difference between lower limbs (ΔWBP)between the 4th and the 10th day post surgeryWeight Bearing Percentage difference between lower limbs in % as reported by the stabilometric platform
Weight Bearing Percentage Healthy limb (WBPH)between the 4th and the 10th day post surgeryWeight Bearing Percentage Healthy limb in % as reported by the stabilometric platform
Weight Bearing Percentage Surgical limb (WBPS)between the 4th and the 10th day post surgeryWeight Bearing Percentage Surgical limb in % as reported by the stabilometric platform
Weight Bearing Absolute Healthy limb (WBAH)between the 4th and the 10th day post surgeryWeight Bearing Absolute Healthy limb in kg as reported by the stabilometric platform
Weight Bearing Absolute Surgical limb (WBAS)between the 4th and the 10th day post surgeryWeight Bearing Absolute Surgical limb in kg as reported by the stabilometric platform

Secondary

MeasureTime frameDescription
Sway Surgical limb (SWS)between the 4th and the 10th day post surgerySway Surgical limb in mm as reported by the stabilometric platform
Six Minutes Walking Test (6MWT)between the 4th and the 10th day post surgerySix Minutes Walking Test in m
Double Support Time (DST)between the 4th and the 10th day post surgeryDouble Support Time in ms as reported by the stabilometric platform
World Health Organization Quality of Life Questionnaire (WHOQOL)between the 4th and the 10th day post surgeryWorld Health Organization Quality of Life Questionnaire
Numeric Rating Scale (NRS)between the 4th and the 10th day post surgeryNumeric Rating Scale
Mid Step Length Healthy limb (MSLH)between the 4th and the 10th day post surgeryMid Step Length Healthy limb in mm as reported by the stabilometric platform
Mid Step Length Surgical limb (MSLS)between the 4th and the 10th day post surgeryMid Step Length Surgical limb in mm as reported by the stabilometric platform
Sway Healthy limb (SWH)between the 4th and the 10th day post surgerySway Healthy limb in mm as reported by the stabilometric platform

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026