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Trial record 96 of 611 for:    "Hip replacement"

Neurocognitive Rehabilitation After Hip Replacement

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ClinicalTrials.gov Identifier: NCT02231567
Recruitment Status : Suspended
First Posted : September 4, 2014
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
Teresa Paolucci, University of Roma La Sapienza

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.

Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Other: Neurocognitive Rehabilitation Other: Traditional Rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Neurocognitive Rehabilitation in Pain Management and Functional Recovery After Hip Replacement: Randomized Controlled Trial
Study Start Date : September 2014
Actual Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neurocognitive Rehabilitation
Rehabilitative approach based on exercises proposed as sensory-motor problems, whose solution involves the use of higher cognitive functions (attention, memory, language).
Other: Neurocognitive Rehabilitation
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.

Active Comparator: Traditional Rehabilitation
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.
Other: Traditional Rehabilitation
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 Measures :
  1. Change of WOMAC Questionnaire from baseline to 24 weeks [ Time Frame: baseline, 1 week, 8 weeks, 16 weeks, 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 :
  1. Change of Barthel Index from baseline to 24 weeks [ Time Frame: baseline, 1 week, 8 weeks, 16 weeks, 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).

  2. Change of Visual Analogue Scale (VAS) from baseline to 24 weeks [ Time Frame: baseline, 1 week, 8 weeks, 16 weeks, 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.

  3. Change of SF-36 Health Survey Questionnaire from baseline to 24 weeks [ Time Frame: baseline, 1 week, 8 weeks, 16 weeks, 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.

  4. Change of Psychological Well-Being Questionnaire (PWB) from baseline to 24 weeks [ Time Frame: baseline, 1 week, 8 weeks, 16 weeks, 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.

  5. Change of parameters of Gait Analysis from baseline to 24 weeks [ Time Frame: baseline, 1 week, 8 weeks, 16 weeks, 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.



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02231567


Locations
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Italy
Umberto I Hospital
Rome, Italy, 00165
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
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Principal Investigator: Vincenzo Maria Saraceni Umberto I Hospital, Sapienza University of Rome

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Responsible Party: Teresa Paolucci, medical director, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02231567     History of Changes
Other Study ID Numbers: 3298/2014
First Posted: September 4, 2014    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016

Keywords provided by Teresa Paolucci, University of Roma La Sapienza:
hip replacement
neurocognitive rehabilitation
WOMAC questionnaire

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases