NCT04268082

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

4 months

First QC Date

February 6, 2020

Last Update Submit

February 12, 2020

Conditions

Total Hip ReplacementVisual BiofeedbackWeight Bearing

Outcome Measures

Primary Outcomes (6)

  • Weight Bearing Absolute difference between lower limbs (ΔWBA)

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

    between the 4th and the 10th day post surgery

  • Weight Bearing Percentage difference between lower limbs (ΔWBP)

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

    between the 4th and the 10th day post surgery

  • 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

  • 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

  • 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

  • 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 Outcomes (8)

  • Mid Step Length Healthy limb (MSLH)

    between the 4th and the 10th day post surgery

  • Mid Step Length Surgical limb (MSLS)

    between the 4th and the 10th day post surgery

  • Sway Healthy limb (SWH)

    between the 4th and the 10th day post surgery

  • Sway Surgical limb (SWS)

    between the 4th and the 10th day post surgery

  • Double Support Time (DST)

    between the 4th and the 10th day post surgery

  • +3 more secondary outcomes

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Device: Visual biofeedback with the use of sensorized insoles

Control Group

ACTIVE COMPARATOR

The Control Group followed verbal instructions of physiotherapist during training.

Other: Standard rehabilitation based on physiotherapist's verbal instructions

Interventions

Visual biofeedback with the use of sensorized insolesDEVICE

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.

Experimental Group
Standard rehabilitation based on physiotherapist's verbal instructionsOTHER

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.

Control Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≤ 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Città di Pavia" University Hospital, Pavia, Italy

Pavia, 27100, Italy

Location

Study Officials

  • Luca Marin, PhD

    University of Pavia, Pavia, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 13, 2020

Study Start

April 1, 2018

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

February 13, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)