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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Total Hip Replacement, Visual Biofeedback, Weight Bearing

Intervention / Treatment
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* Device: Visual biofeedback with the use of sensorized insoles
* Other: Standard rehabilitation based on physiotherapist's verbal instructions


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>The Experimental Group followed the training wearing sensorized insoles that provided plantar pressures and shift of foot center of pressure images reported on monitors. | Device: Visual biofeedback with the use of sensorized insoles<br>* 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.<br>|
| Active Comparator: Control Group<br>The Control Group followed verbal instructions of physiotherapist during training. | Other: Standard rehabilitation based on physiotherapist's verbal instructions<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Bearing Absolute difference between lower limbs (ΔWBA) | Weight Bearing Absolute difference between lower limbs in kg as reported by the stabilometric platform | 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 | 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 | 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 | 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 | 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 | between the 4th and the 10th day post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mid Step Length Healthy limb (MSLH) | Mid Step Length Healthy limb in mm as reported by the stabilometric platform | 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 | between the 4th and the 10th day post surgery | 
| Sway Healthy limb (SWH) | Sway Healthy limb in mm as reported by the stabilometric platform | between the 4th and the 10th day post surgery | 
| Sway Surgical limb (SWS) | Sway Surgical limb in mm as reported by the stabilometric platform | between the 4th and the 10th day post surgery | 
| Double Support Time (DST) | Double Support Time in ms as reported by the stabilometric platform | between the 4th and the 10th day post surgery | 
| Numeric Rating Scale (NRS) | Numeric Rating Scale | between the 4th and the 10th day post surgery | 
| Six Minutes Walking Test (6MWT) | Six Minutes Walking Test in m | between the 4th and the 10th day post surgery | 
| World Health Organization Quality of Life Questionnaire (WHOQOL) | World Health Organization Quality of Life Questionnaire | between the 4th and the 10th day post surgery |