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

NCT04095338 | Unknown

• 1 other identifier: INRCA_03_2019
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 2

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.

Conditions

Hip Fractures; Frail Elderly; Robotic Rehabilitation

Keywords

hip fracture; rehabilitation; robotics

Outcome Measures

Primary Outcomes (1)

• difference in falling risk among virtual reality games arm, robotic treadmill arm and control arm

  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

  before treatment, and 5 weeks, 6 months, 12 months and 24 months after intervention commencement

Secondary Outcomes (2)

• 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

• 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

Study Arms (3)

control group

ACTIVE COMPARATOR

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

Other: traditional rehabilitation

virtual reality games arm

EXPERIMENTAL

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

Other: virtual reality games intervention

robotic treadmill arm

EXPERIMENTAL

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

Other: robotic treadmill intervention

Interventions

traditional rehabilitation OTHER

Each session will include 50 minutes of traditional physical rehabilitation therapy

control group

virtual reality games intervention 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).

virtual reality games arm

robotic treadmill intervention 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.

robotic treadmill arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Nazionale di Ricovero e Cura per Anziani: lead

Study Sites (2)

INRCA Research Hospital

Ancona, 60131, Italy

RECRUITING

INRCA Research Hospital

Fermo, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 36070134 DERIVED

• 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.

  PMID: 32546491 DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Giovanni Riccardi

  IRCCS-INRCA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberta Bevilacqua

CONTACT

00390718004767; r.bevilacqua@inrca.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 19, 2019
• Study Start: November 26, 2019
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

IT (2)