Neurocognitive Rehabilitation After Hip Replacement

NCT02231567 | Terminated DMC

• 1 other identifier: 3298/2014
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Osteoarthritis

Keywords

hip replacement; neurocognitive rehabilitation; WOMAC questionnaire

Outcome Measures

Primary Outcomes (1)

• 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).

  baseline, 1 week, 8 weeks, 16 weeks, 24 weeks

Secondary Outcomes (5)

• Change of Barthel Index from baseline to 24 weeks

  baseline, 1 week, 8 weeks, 16 weeks, 24 weeks

• Change of Visual Analogue Scale (VAS) from baseline to 24 weeks

  baseline, 1 week, 8 weeks, 16 weeks, 24 weeks

• Change of SF-36 Health Survey Questionnaire from baseline to 24 weeks

  baseline, 1 week, 8 weeks, 16 weeks, 24 weeks

• Change of Psychological Well-Being Questionnaire (PWB) from baseline to 24 weeks

  baseline, 1 week, 8 weeks, 16 weeks, 24 weeks

• Change of parameters of Gait Analysis from baseline to 24 weeks

  baseline, 1 week, 8 weeks, 16 weeks, 24 weeks

Study Arms (2)

Neurocognitive Rehabilitation

EXPERIMENTAL

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

Traditional Rehabilitation

ACTIVE COMPARATOR

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

Interventions

Neurocognitive Rehabilitation OTHER

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.

Neurocognitive Rehabilitation

Traditional Rehabilitation OTHER

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.

Traditional Rehabilitation

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Umberto I Hospital

Rome, 00165, Italy

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Vincenzo Maria Saraceni

  Umberto I Hospital, Sapienza University of Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical director

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: September 4, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: March 24, 2020

Record last verified: 2016-01

Locations

IT (1)