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

Not Applicable

Completed

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

• Registration Number: NCT04268082
• Lead Sponsor: University of Pavia

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.

Study Timeline

• Study Start: 2018-04-01
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31
• Status Verified: 2020-02
• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-12
• Last Update Submitted: 2020-02-12
• Study First Posted: 2020-02-13
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Visual biofeedback with the use of sensorized insoles	The 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	Standard rehabilitation based on physiotherapist's verbal instructions	The Control Group followed verbal instructions of physiotherapist during training.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

"Città di Pavia" University Hospital, Pavia, Italy; 🇮🇹 Pavia, Italy