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

NCT ID: NCT04095338

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-26
• Study Completion Date: 2024-03-30

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.

Conditions

Hip Fractures; Frail Elderly; Robotic Rehabilitation

Study Design

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

Study Groups

control group

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

Group Type: ACTIVE_COMPARATOR

traditional rehabilitation

Intervention Type: OTHER

Each session will include 50 minutes of traditional physical rehabilitation therapy

virtual reality games arm

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

Group Type: EXPERIMENTAL

virtual reality games intervention

Intervention Type: OTHER

Each session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic training by Tymo system (Tyromotion, Austria), a wireless platform for the balance and the postural control training that simulates floor walking and stairs climbing. Tymo system is connected to a screen and provides virtual reality games, adaptable to the functional capacity of the patient. Through the games proposed, the physiotherapist will decide to work in a dimension (antero-posterior or medio-lateral dimension) or in two dimensions (combining the antero-posterior and medio-lateral movements).

robotic treadmill arm

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

Group Type: EXPERIMENTAL

robotic treadmill intervention

Intervention Type: OTHER

Each session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic training by Walker view (TecnoBody, Italy), a treadmill equipped with a sensorized belt with eight load cells and a 3D camera.to detect length, speed and symmetry of the pace and load, range of the trunk, hips and knees. Patients will be asked to walk at a comfortable speed, while the physiotherapist will be able to work on different parameters such as step length, load distribution, and step height. The setting will take place taking into account the clinical conditions of each patient, customizing the intervention. The Walker View will offer visual and auditory feedback to the patient, so as to correct gait in real time.

Interventions

traditional rehabilitation

Each session will include 50 minutes of traditional physical rehabilitation therapy

Intervention Type: OTHER

virtual reality games intervention

Each session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic training by Tymo system (Tyromotion, Austria), a wireless platform for the balance and the postural control training that simulates floor walking and stairs climbing. Tymo system is connected to a screen and provides virtual reality games, adaptable to the functional capacity of the patient. Through the games proposed, the physiotherapist will decide to work in a dimension (antero-posterior or medio-lateral dimension) or in two dimensions (combining the antero-posterior and medio-lateral movements).

Intervention Type: OTHER

robotic treadmill intervention

Each session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic training by Walker view (TecnoBody, Italy), a treadmill equipped with a sensorized belt with eight load cells and a 3D camera.to detect length, speed and symmetry of the pace and load, range of the trunk, hips and knees. Patients will be asked to walk at a comfortable speed, while the physiotherapist will be able to work on different parameters such as step length, load distribution, and step height. The setting will take place taking into account the clinical conditions of each patient, customizing the intervention. The Walker View will offer visual and auditory feedback to the patient, so as to correct gait in real time.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giovanni Riccardi

Role: PRINCIPAL_INVESTIGATOR

IRCCS-INRCA

Locations

INRCA Research Hospital

Ancona, , Italy

Site Status: RECRUITING

INRCA Research Hospital

Fermo, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Roberta Bevilacqua

Role: CONTACT

r.bevilacqua@inrca.it

00390718004767

Facility Contacts

Elvira Maranesi

Role: primary

e.maranesi@inrca.it

Valentina Di Donna

Role: primary

v.didonna@inrca.it

References

Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.

Reference Type: DERIVED

PMID: 36070134 (View on PubMed)

Maranesi E, Riccardi GR, Lattanzio F, Di Rosa M, Luzi R, Casoni E, Rinaldi N, Baldoni R, Di Donna V, Bevilacqua R. Randomised controlled trial assessing the effect of a technology-assisted gait and balance training on mobility in older people after hip fracture: study protocol. BMJ Open. 2020 Jun 15;10(6):e035508. doi: 10.1136/bmjopen-2019-035508.

Reference Type: DERIVED

PMID: 32546491 (View on PubMed)

Other Identifiers

INRCA_03_2019

Identifier Type: -

Identifier Source: org_study_id