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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: Hip Fractures; Frail Elderly; Robotic Rehabilitation

Treatments: Other: virtual reality games intervention; Other: traditional rehabilitation; Other: robotic treadmill intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04095338

INRCA_03_2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 195 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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195 participants in 3 patient groups

control group

Active Comparator group

Description:

Ten traditional physical treatment sessions divided into 2 training sessions per week for 5 weeks

Treatment:

Other: traditional rehabilitation

virtual reality games arm

Experimental group

Description:

Ten technological treatment sessions divided into 2 training sessions per week for 5 weeks.

Treatment:

Other: virtual reality games intervention

robotic treadmill arm

Experimental group

Description:

Ten traditional physical treatment sessions divided into 2 training sessions per week for 5 weeks.

Treatment:

Other: robotic treadmill intervention