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

Not Applicable

Recruiting

• Conditions: Hip Fractures; Frail Elderly; Robotic Rehabilitation
• Interventions: Other: traditional rehabilitation; Other: virtual reality games intervention; Other: robotic treadmill intervention

• Registration Number: NCT04095338
• Lead Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-09-16
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-19
• Study Start: 2019-11-26
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-23
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 195

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	traditional rehabilitation	Ten traditional physical treatment sessions divided into 2 training sessions per week for 5 weeks
virtual reality games arm	virtual reality games intervention	Ten technological treatment sessions divided into 2 training sessions per week for 5 weeks.
robotic treadmill arm	robotic treadmill intervention	Ten traditional physical treatment sessions divided into 2 training sessions per week for 5 weeks.

Primary Outcome Measures

Name	Time	Method
difference in falling risk among virtual reality games arm, robotic treadmill arm and control arm	before treatment, and 5 weeks, 6 months, 12 months and 24 months after intervention commencement	falling risk will be evaluated by the Tinetti performance oriented mobility assessment (POMA). POMA test has two subscales, Balance and Gait sections. Total score is obtained by adding the scores of the two subscales (balance + gait) . Total score \< 19 high fall risk, total score 19-24 medium fall risk, total score 25-28 low fall risk

Secondary Outcome Measures

Name	Time	Method
difference in fear of falling among virtual reality games arm, robotic treadmill arm and control arm	before treatment, and 5 weeks, 6 months, 12 months and 24 months after intervention commencement	fear of falling will be evaluated by the Falls Efficacy Scale - International (FES-I). Higher scores represent greater the fear of falling (ranging from 16 to 64)
difference in gait performance among virtual reality games arm, robotic treadmill arm and control arm	before treatment, and 5 weeks, 6 months, 12 months and 24 months after intervention commencement	gait performance will be evaluated by the walking speed evaluated by instrumental gait analysis

Trial Locations

Locations (1)

INRCA Research Hospital; 🇮🇹 Fermo, Italy