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NCT Number: NCT04268082

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

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.

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Key information

Conditions

Total Hip Replacement Visual Biofeedback Weight Bearing

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

"Città di Pavia" University Hospital, Pavia, Italy

Pavia, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Visual biofeedback with the use of sensorized insoles

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.

Standard rehabilitation based on physiotherapist's verbal instructions

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.

Primary outcomes

  1. Weight Bearing Absolute difference between lower limbs (ΔWBA)

    Time frame: between the 4th and the 10th day post surgery

    Weight Bearing Absolute difference between lower limbs in kg as reported by the stabilometric platform

  2. Weight Bearing Percentage difference between lower limbs (ΔWBP)

    Time frame: between the 4th and the 10th day post surgery

    Weight Bearing Percentage difference between lower limbs in % as reported by the stabilometric platform

  3. Weight Bearing Percentage Healthy limb (WBPH)

    Time frame: between the 4th and the 10th day post surgery

    Weight Bearing Percentage Healthy limb in % as reported by the stabilometric platform

  4. Weight Bearing Percentage Surgical limb (WBPS)

    Time frame: between the 4th and the 10th day post surgery

    Weight Bearing Percentage Surgical limb in % as reported by the stabilometric platform

  5. Weight Bearing Absolute Healthy limb (WBAH)

    Time frame: between the 4th and the 10th day post surgery

    Weight Bearing Absolute Healthy limb in kg as reported by the stabilometric platform

  6. Weight Bearing Absolute Surgical limb (WBAS)

    Time frame: between the 4th and the 10th day post surgery

    Weight Bearing Absolute Surgical limb in kg as reported by the stabilometric platform

Secondary outcomes

  1. Mid Step Length Healthy limb (MSLH)

    Time frame: between the 4th and the 10th day post surgery

    Mid Step Length Healthy limb in mm as reported by the stabilometric platform

  2. Mid Step Length Surgical limb (MSLS)

    Time frame: between the 4th and the 10th day post surgery

    Mid Step Length Surgical limb in mm as reported by the stabilometric platform

  3. Sway Healthy limb (SWH)

    Time frame: between the 4th and the 10th day post surgery

    Sway Healthy limb in mm as reported by the stabilometric platform

  4. Sway Surgical limb (SWS)

    Time frame: between the 4th and the 10th day post surgery

    Sway Surgical limb in mm as reported by the stabilometric platform

  5. Double Support Time (DST)

    Time frame: between the 4th and the 10th day post surgery

    Double Support Time in ms as reported by the stabilometric platform

  6. Numeric Rating Scale (NRS)

    Time frame: between the 4th and the 10th day post surgery

    Numeric Rating Scale

  7. Six Minutes Walking Test (6MWT)

    Time frame: between the 4th and the 10th day post surgery

    Six Minutes Walking Test in m

  8. World Health Organization Quality of Life Questionnaire (WHOQOL)

    Time frame: between the 4th and the 10th day post surgery

    World Health Organization Quality of Life Questionnaire

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 13, 2020
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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