Clinical trial NCT04268082: Insole-based Visual Biofeedback for Weight-bearing in Total Hip Replacement
Official title: The Effects of Insole-based Visual Biofeedback on Weight-bearing in Patients Undergoing Total Hip Replacement. A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Replacement
Visual Biofeedback
Weight Bearing
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Weight Bearing Absolute difference between lower limbs (ΔWBA)
timeFrame: between the 4th and the 10th day post surgery
measure: Weight Bearing Percentage difference between lower limbs (ΔWBP)
timeFrame: between the 4th and the 10th day post surgery
measure: Weight Bearing Percentage Healthy limb (WBPH)
timeFrame: between the 4th and the 10th day post surgery
measure: Weight Bearing Percentage Surgical limb (WBPS)
timeFrame: between the 4th and the 10th day post surgery
measure: Weight Bearing Absolute Healthy limb (WBAH)
timeFrame: between the 4th and the 10th day post surgery
measure: Weight Bearing Absolute Surgical limb (WBAS)
timeFrame: between the 4th and the 10th day post surgery
Secondary outcomes:
measure: Mid Step Length Healthy limb (MSLH)
timeFrame: between the 4th and the 10th day post surgery
measure: Mid Step Length Surgical limb (MSLS)
timeFrame: between the 4th and the 10th day post surgery
measure: Sway Healthy limb (SWH)
timeFrame: between the 4th and the 10th day post surgery
measure: Sway Surgical limb (SWS)
timeFrame: between the 4th and the 10th day post surgery
measure: Double Support Time (DST)
timeFrame: between the 4th and the 10th day post surgery
measure: Numeric Rating Scale (NRS)
timeFrame: between the 4th and the 10th day post surgery
measure: Six Minutes Walking Test (6MWT)
timeFrame: between the 4th and the 10th day post surgery
measure: World Health Organization Quality of Life Questionnaire (WHOQOL)
timeFrame: between the 4th and the 10th day post surgery
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: "Città di Pavia" University Hospital, Pavia, Italy
Study officials:
affiliation: University of Pavia, Pavia, Italy
name: Luca Marin, PhD
role: PRINCIPAL_INVESTIGATOR
References: