Innovative Models in the Rehabilitation of the Elderly With Hip Fractures Through Technological Innovation

Last updated: October 20, 2023
Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoporosis

Treatment

traditional rehabilitation

robotic treadmill intervention

virtual reality games intervention

Clinical Study ID

NCT04095338
INRCA_03_2019
  • Ages > 65
  • All Genders

Study Summary

The final goals of the present study is to propose a new approach in the hip fracture rehabilitation in elderly subjects, focused on the use of robotic device and to check the results not only at the end of the treatment but also in the long term, foreseeing 3 follow-up.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Capacity to consent
  • Traumatic event within 60 days
  • Romberg test: negative
  • Functional Ambulation Category (FAC) score ≤ 2
  • Ranking scale score ≤ 3;

Exclusion

Exclusion Criteria:

  • Past history of syncopal episodes
  • Presence of non-pharmacologically compensated behavioral syndromes
  • Presence of pain that prevents walking or standing
  • Presence of neurological pathologies that compromise balance (Multiple sclerosis,Parkinson's disease, stroke, ataxias, poliomyelitis)
  • Spinal stenosis
  • Radiculopathy
  • Neuropathies lower limbs
  • Disabling disabilities that impair walking (eg congenital malformations of the foot)
  • Heterometry > 2 cm
  • Clinical dementia rating (CDR) score ≥ 3
  • Severe systemic diseases with life expectancy < 1 year
  • Patients unable to follow up.

Study Design

Total Participants: 195
Treatment Group(s): 3
Primary Treatment: traditional rehabilitation
Phase:
Study Start date:
November 26, 2019
Estimated Completion Date:
March 30, 2024

Study Description

Balance and deficit in walking are some of the main characteristics of aging and are considered among the risk factors for falls. Falls are a risk factor for future falls and are associated with other adverse health outcomes such as fear of falling or fractures. In particular, hip fracture in aged patients is an important health problem. In fact, one in three patients dies within the first year after injury, while survivors have poor quality of life For this reason, the development of prevention tools and innovative strategies in the rehabilitation field should be one of the main objectives in the treatment of the diseases afflicting the elderly, such as hip fractures. Effective interventions to promote hip recovery post hip fracture are characterized by intensive and repetitive movements. One treatment approach to increase number of steps during rehabilitation sessions and to improve the balance and the endurance of the patients is the use of robotic systems.

This study is a randomized controlled trial. A total of 195 patients with hip fractures will be recruited and randomly divided into three groups, to receive a traditional rehabilitation program or a robotic rehabilitation in addition to the traditional therapy. Assessments will be performed at baseline, at the end of treatment and 6 months, 1 year and 2 years from the end of the treatment. For the study, post-hospitalization subjects will be taken into consideration, after four weeks from the hospitalization. A 20 treatment sessions will be conducted, divided into 3 training sessions per week, for 7 weeks. The control group will perform traditional therapy sessions lasting 50 minutes. The technological intervention group will carry out 30 minutes of traditional therapy and 20 minutes of treatment with a robotic system.

Connect with a study center

  • INRCA Research Hospital

    Ancona, 60131
    Italy

    Active - Recruiting

  • INRCA Research Hospital

    Fermo,
    Italy

    Active - Recruiting

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