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Completed

NCT Number: NCT04803578

The Effectiveness of Rehabilitation in Gait Recovery After Knee or Hip Arthroplasty

This study aims to evaluate the effectiveness of rehabilitation on gait recovery in subjects after knee or hip arthroplasty. Assessment is performed the day after admission (T0) and the day of discharge (T1), in a post-acute rehabilitation hospital, through an optoelectronic system (BTS DX-400). Other functional scales are administered to the subjects. during the rehabilitation period, subjects received conventional physiotherapy.

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Key information

Conditions

Arthroplasty, Replacement, Hip Arthroplasty, Replacement, Knee

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Fondazione Don Carlo Gnocchi

Milan, 20148, Italy

Who can participate

Healthy volunteers accepted: Yes

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

Knee and Hip Arthroplasty subjects

Inclusion criteria

  • Subjects > 18 years;
  • Both Sexs;
  • Knee or Hip Arthroplasty in the previous 3-4 days before admission;
  • Subjects with clinical stability at admission (Hemoglobin > 9 g/l).

Exclusion criteria

  • Fever at admission;
  • Any rheumatic or systemic diseases;
  • Previous surgery at the lower limbs (6 months before admission) or other arthroplasties at the lower limbs;
  • MiniMental State Examination < 24;
  • Other neurologic disorders.

For the healthy volunteers

Inclusion criteria

  • Subjects age-matched with the subjects in the hip and knee group.

Exclusion criteria

  • Any disorder that could negatively affect gait perfomance.

Treatment and study plan

Conventional Physiotherapy

Other

The subjects will receive rehabilitation according to the guidelines on the management of subjects after knee or hip arthroplasty, recovery of joint Range of Motion, recovery of lower limb strength, education to the crutches management, and stairs climbing and descending

Primary outcomes

  1. Change in Gait Profile Score

    Time frame: From Admission (T0) up to 15/21 days (discharge) (T1)

    Change from Admission of Gait Profile Score untill 15/21 days (Discharge)

  2. Change in Gai Deviation Index

    Time frame: From Admission (T0) up to 15/21 days (discharge) (T1)

    Change from Admission of Gait Deviation Index untill 15/21 days (Discharge)

  3. Change in Gait Variable Scores

    Time frame: From Admission (T0) up to 15/21 days (discharge) (T1)

    Change from Admission of Gait Variable Score untill 15/21 days (Discharge)

  4. Change in gait speed

    Time frame: From Admission (T0) up to 15/21 days (discharge) (T1)

    Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)

  5. Change in gait cycle length

    Time frame: From Admission (T0) up to 15/21 days (discharge) (T1)

    Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)

  6. Change in step length

    Time frame: From Admission (T0) up to 15/21 days (discharge) (T1)

    Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)

  7. Change in gait cadence

    Time frame: From Admission (T0) up to 15/21 days (discharge) (T1)

    Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)

  8. Change in gait cycle duration

    Time frame: From Admission (T0) up to 15/21 days (discharge) (T1)

    Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)

  9. Change in stance phase duration

    Time frame: From Admission (T0) up to 15/21 days (discharge) (T1)

    Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)

  10. Change in swing phase duration

    Time frame: From Admission (T0) up to 15/21 days (discharge) (T1)

    Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)

  11. Change in single support phase duration

    Time frame: From Admission (T0) up to 15/21 days (discharge) (T1)

    Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)

  12. Change in double support phase duration

    Time frame: From Admission (T0) up to 15/21 days (discharge) (T1)

    Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)

Secondary outcomes

  1. Change in Modified Barthel Index

    Time frame: From Admission (T0) up to 15/21 days (discharge) (T1)

    Change from Admission of Modified Bathel Index untill 15/21 days (Discharge)

  2. Change in International Knee Society score

    Time frame: From Admission (T0) up to 15/21 days (discharge) (T1)

    Change from Admission of International Knee Society score untill 15/21 days (Discharge)

  3. Change in Merlè D'Aubigne score

    Time frame: From Admission (T0) up to 15/21 days (discharge) (T1)

    Change from Admission of Merlè D'Aubigne score untill 15/21 days (Discharge)

  4. Change in Numerical Pain Rating Scale

    Time frame: From Admission (T0) up to 15/21 days (discharge) (T1)

    Change from Admission of Numerical Pain Rating Scale untill 15/21 days (Discharge)

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

The Effectiveness of Rehabilitation in Gait Recovery After Knee or Hip Arthroplasty: a Pilot Observational Study Based on Kinematic and Kinetic Parameters

Acronym: Fast-Track2

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Mar 17, 2021
Registry last updated
Aug 30, 2023

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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