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Neurocognitive Rehabilitation After Hip Replacement

Primary Purpose

Hip Osteoarthritis

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Neurocognitive Rehabilitation
Traditional Rehabilitation
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis focused on measuring hip replacement, neurocognitive rehabilitation, WOMAC questionnaire

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Presence of symptomatic unilateral primary hip osteoarthritis treated with surgical replacement with a posterior-lateral approach and the use of a non-cemented prosthesis (press-fit). All the implants are composed of a stem Symax (Stryker-Howmedica) and a ceramic head with coupling ceramic-ceramic and are implanted by the same surgeon.

Exclusion Criteria:

  • Different diagnosis from hip osteoarthritis (eg. Fracture)
  • Concomitant osteoarthrosis of the hip or knee with gait restrictions
  • Lameness for more than six months
  • Central nervous system or Peripheral nervous system disorders
  • Systemic inflammatory disorders (eg. Rheumatoid Arthritis)
  • Systemic infectious disorders
  • Cognitive impairment
  • Neoplastic disorders
  • Surgical revisions
  • Intraoperative complications
  • Suspected hip replacement infection
  • Hip replacement with endoprosthesis.

Sites / Locations

  • Umberto I Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neurocognitive Rehabilitation

Traditional Rehabilitation

Arm Description

Rehabilitative approach based on exercises proposed as sensory-motor problems, whose solution involves the use of higher cognitive functions (attention, memory, language).

It is a rehabilitative approach based on exercises for the recovery of hip's range of motion, muscle strengthening exercises, stretching exercises of the hamstring muscles, adductor and iliopsoas and proprioceptive exercises.

Outcomes

Primary Outcome Measures

Change of WOMAC Questionnaire from baseline to 24 weeks
Questionnaire for the assessment of pain, stiffness and physical function. It measures physical function and symptoms of the lower limb and explores the impact of disability and pain on activities of daily living. The questionnaire is self-administered and it is based on a metric scale ranging from 0 (no difficulty) to 100 (extreme difficulty).

Secondary Outcome Measures

Change of Barthel Index from baseline to 24 weeks
Index for the evaluation of patient's performance in activities of daily living. The index is divided into eleven sub-categories that assess activities of daily living (ability to feed themselves, to ensure personal hygiene and dressing) and the mobility of the individual (gait, postural changes and transfers, stairs). For each item is assigned a score variable from full to reduced or absent functionality. The questionnaire is administered by an examiner and is based on a metric scale ranging from 0 (total dependence) to 100 (minimum dependence).
Change of Visual Analogue Scale (VAS) from baseline to 24 weeks
It is based on a ten point scale, where 0 means no pain and 10 means the greatest pain ever. It enables the patients to express their pain intensity as numerical value.
Change of SF-36 Health Survey Questionnaire from baseline to 24 weeks
Assessment of health status using the SF-36 Health Survey Questionnaire. The questionnaire is divided into eight sub-categories that measure the physical activity, role limitations due to physical health and emotional problems, physical pain, the perception of general health, vitality, social activities, mental health and changes in health status and two indices that summarize the overall assessment of the subject with respect to his physical health (ISF) and mental (ISM). Indices are derived from 8 subcategories evaluated and allow to summarize the results. The questionnaire is self-administered and subcategories is that the indices are based on a metric scale ranging from 0 (worst health status) to 100 (best health status) 17, 18.
Change of Psychological Well-Being Questionnaire (PWB) from baseline to 24 weeks
Questionnaire for the assessment of psychological well-being and positive functioning of the individual. It includes 84 items and measures the six dimensions /scales of well-being proposed in the model developed by the American psychologist Carol Ryff: self-acceptance, positive interpersonal relationships, autonomy, environmental control, personal growth and purpose in life. The questionnaire is self-administered and each item is evaluated by a metric scale ranging from 1 (disagree) to 6 (totally agree). The negatively worded items are counted in reverse order. The sum score for each scale is calculated by summing the degree of agreement of each item.
Change of parameters of Gait Analysis from baseline to 24 weeks
It's used to define the pattern of gait. The Gait Analysis provides different types of information such as quantitative kinematics data (angles of flexion-extension, abduction-adduction and external rotation of the main joints), velocity data (moments and powers the major joints) and electromyographic data.

Full Information

First Posted
August 8, 2014
Last Updated
March 23, 2020
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT02231567
Brief Title
Neurocognitive Rehabilitation After Hip Replacement
Official Title
Effectiveness of Neurocognitive Rehabilitation in Pain Management and Functional Recovery After Hip Replacement: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to evaluate the effectiveness of an approach based on neurocognitive rehabilitation exercises in the form of sensory-motor problems, whose solution involves the use of higher cognitive functions (attention, memory, language), not required in a traditional approach proprioceptive, in order to obtain a more complete and long-lasting recovery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
hip replacement, neurocognitive rehabilitation, WOMAC questionnaire

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurocognitive Rehabilitation
Arm Type
Experimental
Arm Description
Rehabilitative approach based on exercises proposed as sensory-motor problems, whose solution involves the use of higher cognitive functions (attention, memory, language).
Arm Title
Traditional Rehabilitation
Arm Type
Active Comparator
Arm Description
It is a rehabilitative approach based on exercises for the recovery of hip's range of motion, muscle strengthening exercises, stretching exercises of the hamstring muscles, adductor and iliopsoas and proprioceptive exercises.
Intervention Type
Other
Intervention Name(s)
Neurocognitive Rehabilitation
Intervention Description
The patients will be treated in inpatient clinic with a neurocognitive rehabilitation approach. The frequency will be two times a day for six days a week for four consecutive weeks. Followed by outpatient treatment three times a week for four weeks. Each session lasts about one hour.
Intervention Type
Other
Intervention Name(s)
Traditional Rehabilitation
Intervention Description
The patients will be treated in inpatient clinic with a traditional rehabilitation approach. The frequency will be two times a day for six days a week for four consecutive weeks. Followed by outpatient treatment three times a week for four weeks. Each session lasts about one hour.
Primary Outcome Measure Information:
Title
Change of WOMAC Questionnaire from baseline to 24 weeks
Description
Questionnaire for the assessment of pain, stiffness and physical function. It measures physical function and symptoms of the lower limb and explores the impact of disability and pain on activities of daily living. The questionnaire is self-administered and it is based on a metric scale ranging from 0 (no difficulty) to 100 (extreme difficulty).
Time Frame
baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Change of Barthel Index from baseline to 24 weeks
Description
Index for the evaluation of patient's performance in activities of daily living. The index is divided into eleven sub-categories that assess activities of daily living (ability to feed themselves, to ensure personal hygiene and dressing) and the mobility of the individual (gait, postural changes and transfers, stairs). For each item is assigned a score variable from full to reduced or absent functionality. The questionnaire is administered by an examiner and is based on a metric scale ranging from 0 (total dependence) to 100 (minimum dependence).
Time Frame
baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
Title
Change of Visual Analogue Scale (VAS) from baseline to 24 weeks
Description
It is based on a ten point scale, where 0 means no pain and 10 means the greatest pain ever. It enables the patients to express their pain intensity as numerical value.
Time Frame
baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
Title
Change of SF-36 Health Survey Questionnaire from baseline to 24 weeks
Description
Assessment of health status using the SF-36 Health Survey Questionnaire. The questionnaire is divided into eight sub-categories that measure the physical activity, role limitations due to physical health and emotional problems, physical pain, the perception of general health, vitality, social activities, mental health and changes in health status and two indices that summarize the overall assessment of the subject with respect to his physical health (ISF) and mental (ISM). Indices are derived from 8 subcategories evaluated and allow to summarize the results. The questionnaire is self-administered and subcategories is that the indices are based on a metric scale ranging from 0 (worst health status) to 100 (best health status) 17, 18.
Time Frame
baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
Title
Change of Psychological Well-Being Questionnaire (PWB) from baseline to 24 weeks
Description
Questionnaire for the assessment of psychological well-being and positive functioning of the individual. It includes 84 items and measures the six dimensions /scales of well-being proposed in the model developed by the American psychologist Carol Ryff: self-acceptance, positive interpersonal relationships, autonomy, environmental control, personal growth and purpose in life. The questionnaire is self-administered and each item is evaluated by a metric scale ranging from 1 (disagree) to 6 (totally agree). The negatively worded items are counted in reverse order. The sum score for each scale is calculated by summing the degree of agreement of each item.
Time Frame
baseline, 1 week, 8 weeks, 16 weeks, 24 weeks
Title
Change of parameters of Gait Analysis from baseline to 24 weeks
Description
It's used to define the pattern of gait. The Gait Analysis provides different types of information such as quantitative kinematics data (angles of flexion-extension, abduction-adduction and external rotation of the main joints), velocity data (moments and powers the major joints) and electromyographic data.
Time Frame
baseline, 1 week, 8 weeks, 16 weeks, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presence of symptomatic unilateral primary hip osteoarthritis treated with surgical replacement with a posterior-lateral approach and the use of a non-cemented prosthesis (press-fit). All the implants are composed of a stem Symax (Stryker-Howmedica) and a ceramic head with coupling ceramic-ceramic and are implanted by the same surgeon. Exclusion Criteria: Different diagnosis from hip osteoarthritis (eg. Fracture) Concomitant osteoarthrosis of the hip or knee with gait restrictions Lameness for more than six months Central nervous system or Peripheral nervous system disorders Systemic inflammatory disorders (eg. Rheumatoid Arthritis) Systemic infectious disorders Cognitive impairment Neoplastic disorders Surgical revisions Intraoperative complications Suspected hip replacement infection Hip replacement with endoprosthesis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincenzo Maria Saraceni
Organizational Affiliation
Umberto I Hospital, Sapienza University of Rome
Official's Role
Principal Investigator
Facility Information:
Facility Name
Umberto I Hospital
City
Rome
ZIP/Postal Code
00165
Country
Italy

12. IPD Sharing Statement

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Neurocognitive Rehabilitation After Hip Replacement

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