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

NCT ID: NCT04268082

Last Updated: 2020-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2018-07-31

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.

Conditions

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Total Hip Replacement Visual Biofeedback Weight Bearing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental Group

The Experimental Group followed the training wearing sensorized insoles that provided plantar pressures and shift of foot center of pressure images reported on monitors.

Group Type EXPERIMENTAL

Visual biofeedback with the use of sensorized insoles

Intervention Type DEVICE

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.

Control Group

The Control Group followed verbal instructions of physiotherapist during training.

Group Type ACTIVE_COMPARATOR

Standard rehabilitation based on physiotherapist's verbal instructions

Intervention Type OTHER

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.

Interventions

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Visual 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.

Intervention Type DEVICE

Standard 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.

Intervention Type OTHER

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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Luca Marin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luca Marin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pavia, Pavia, Italy

Locations

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"Città di Pavia" University Hospital, Pavia, Italy

Pavia, , Italy

Site Status

Countries

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Italy

Other Identifiers

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20180036031

Identifier Type: -

Identifier Source: org_study_id

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