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.

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.

Study Overview

• Status: Completed
• Conditions: Total Hip Replacement; Visual Biofeedback; Weight Bearing
• Intervention / Treatment: Device: Visual biofeedback with the use of sensorized insoles; Other: Standard rehabilitation based on physiotherapist's verbal instructions

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • "Città di Pavia" University Hospital, Pavia, Italy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Active Comparator: Control Group; The Control Group followed verbal instructions of physiotherapist during training.	Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pavia
• Investigators: Principal Investigator: Luca Marin, PhD, University of Pavia, Pavia, Italy

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: February 6, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: 20180036031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No