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

Primary Purpose

Total Hip Replacement, Visual Biofeedback, Weight Bearing

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Visual biofeedback with the use of sensorized insoles
Standard rehabilitation based on physiotherapist's verbal instructions
Sponsored by
University of Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Hip Replacement

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

The Experimental Group followed the training wearing sensorized insoles that provided plantar pressures and shift of foot center of pressure images reported on monitors.

The Control Group followed verbal instructions of physiotherapist during training.

Outcomes

Primary Outcome Measures

Weight Bearing Absolute difference between lower limbs (ΔWBA)
Weight Bearing Absolute difference between lower limbs in kg as reported by the stabilometric platform
Weight Bearing Percentage difference between lower limbs (ΔWBP)
Weight Bearing Percentage difference between lower limbs in % as reported by the stabilometric platform
Weight Bearing Percentage Healthy limb (WBPH)
Weight Bearing Percentage Healthy limb in % as reported by the stabilometric platform
Weight Bearing Percentage Surgical limb (WBPS)
Weight Bearing Percentage Surgical limb in % as reported by the stabilometric platform
Weight Bearing Absolute Healthy limb (WBAH)
Weight Bearing Absolute Healthy limb in kg as reported by the stabilometric platform
Weight Bearing Absolute Surgical limb (WBAS)
Weight Bearing Absolute Surgical limb in kg as reported by the stabilometric platform

Secondary Outcome Measures

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

Full Information

First Posted
February 6, 2020
Last Updated
February 12, 2020
Sponsor
University of Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT04268082
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pavia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Hip Replacement, Visual Biofeedback, Weight Bearing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The Experimental Group followed the training wearing sensorized insoles that provided plantar pressures and shift of foot center of pressure images reported on monitors.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The Control Group followed verbal instructions of physiotherapist during training.
Intervention Type
Device
Intervention Name(s)
Visual biofeedback with the use of sensorized insoles
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard rehabilitation based on physiotherapist's verbal instructions
Intervention Description
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 Outcome Measure Information:
Title
Weight Bearing Absolute difference between lower limbs (ΔWBA)
Description
Weight Bearing Absolute difference between lower limbs in kg as reported by the stabilometric platform
Time Frame
between the 4th and the 10th day post surgery
Title
Weight Bearing Percentage difference between lower limbs (ΔWBP)
Description
Weight Bearing Percentage difference between lower limbs in % as reported by the stabilometric platform
Time Frame
between the 4th and the 10th day post surgery
Title
Weight Bearing Percentage Healthy limb (WBPH)
Description
Weight Bearing Percentage Healthy limb in % as reported by the stabilometric platform
Time Frame
between the 4th and the 10th day post surgery
Title
Weight Bearing Percentage Surgical limb (WBPS)
Description
Weight Bearing Percentage Surgical limb in % as reported by the stabilometric platform
Time Frame
between the 4th and the 10th day post surgery
Title
Weight Bearing Absolute Healthy limb (WBAH)
Description
Weight Bearing Absolute Healthy limb in kg as reported by the stabilometric platform
Time Frame
between the 4th and the 10th day post surgery
Title
Weight Bearing Absolute Surgical limb (WBAS)
Description
Weight Bearing Absolute Surgical limb in kg as reported by the stabilometric platform
Time Frame
between the 4th and the 10th day post surgery
Secondary Outcome Measure Information:
Title
Mid Step Length Healthy limb (MSLH)
Description
Mid Step Length Healthy limb in mm as reported by the stabilometric platform
Time Frame
between the 4th and the 10th day post surgery
Title
Mid Step Length Surgical limb (MSLS)
Description
Mid Step Length Surgical limb in mm as reported by the stabilometric platform
Time Frame
between the 4th and the 10th day post surgery
Title
Sway Healthy limb (SWH)
Description
Sway Healthy limb in mm as reported by the stabilometric platform
Time Frame
between the 4th and the 10th day post surgery
Title
Sway Surgical limb (SWS)
Description
Sway Surgical limb in mm as reported by the stabilometric platform
Time Frame
between the 4th and the 10th day post surgery
Title
Double Support Time (DST)
Description
Double Support Time in ms as reported by the stabilometric platform
Time Frame
between the 4th and the 10th day post surgery
Title
Numeric Rating Scale (NRS)
Description
Numeric Rating Scale
Time Frame
between the 4th and the 10th day post surgery
Title
Six Minutes Walking Test (6MWT)
Description
Six Minutes Walking Test in m
Time Frame
between the 4th and the 10th day post surgery
Title
World Health Organization Quality of Life Questionnaire (WHOQOL)
Description
World Health Organization Quality of Life Questionnaire
Time Frame
between the 4th and the 10th day post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Marin, PhD
Organizational Affiliation
University of Pavia, Pavia, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Città di Pavia" University Hospital, Pavia, Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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

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