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

Total Hip Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04268082
• Other study ID #: 20180036031
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: July 31, 2018

Study information

• Verified date: February 2020
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Body Weight
• Total Hip Replacement
• Visual Biofeedback
• Weight Bearing

Intervention

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.

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.

Locations

Country	Name	City	State
Italy	"Città di Pavia" University Hospital, Pavia, Italy	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Bearing Absolute difference between lower limbs (?WBA)	Weight Bearing Absolute difference between lower limbs in kg as reported by the stabilometric platform	between the 4th and the 10th day post surgery
Primary	Weight Bearing Percentage difference between lower limbs (?WBP)	Weight Bearing Percentage difference between lower limbs in % as reported by the stabilometric platform	between the 4th and the 10th day post surgery
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Sway Healthy limb (SWH)	Sway Healthy limb in mm as reported by the stabilometric platform	between the 4th and the 10th day post surgery
Secondary	Sway Surgical limb (SWS)	Sway Surgical limb in mm as reported by the stabilometric platform	between the 4th and the 10th day post surgery
Secondary	Double Support Time (DST)	Double Support Time in ms as reported by the stabilometric platform	between the 4th and the 10th day post surgery
Secondary	Numeric Rating Scale (NRS)	Numeric Rating Scale	between the 4th and the 10th day post surgery
Secondary	Six Minutes Walking Test (6MWT)	Six Minutes Walking Test in m	between the 4th and the 10th day post surgery
Secondary	World Health Organization Quality of Life Questionnaire (WHOQOL)	World Health Organization Quality of Life Questionnaire	between the 4th and the 10th day post surgery