Neurocognitive Rehabilitation After Hip Replacement

NCT ID: NCT02231567

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Neurocognitive Rehabilitation

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

Group Type: EXPERIMENTAL

Neurocognitive Rehabilitation

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Traditional Rehabilitation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Teresa Paolucci

medical director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vincenzo Maria Saraceni

Role: PRINCIPAL_INVESTIGATOR

Umberto I Hospital, Sapienza University of Rome

Locations

Umberto I Hospital

Rome, , Italy

Countries

Italy

Other Identifiers

3298/2014

Identifier Type: -

Identifier Source: org_study_id