Clinical trial NCT04095338: Innovative Models in the Rehabilitation of the Elderly With Hip Fractures Through Technological Innovation
Official title: Assistive Robotic in the Elderly: Innovative Models in the Rehabilitation of the Elderly With Hip Fractures Through Technological Innovation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Fractures
Frail Elderly
Robotic Rehabilitation
Keywords: hip fracture
rehabilitation
robotics
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 195
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: difference in falling risk among virtual reality games arm, robotic treadmill arm and control arm
timeFrame: before treatment, and 5 weeks, 6 months, 12 months and 24 months after intervention commencement
Secondary outcomes:
measure: difference in gait performance among virtual reality games arm, robotic treadmill arm and control arm
timeFrame: before treatment, and 5 weeks, 6 months, 12 months and 24 months after intervention commencement
measure: difference in fear of falling among virtual reality games arm, robotic treadmill arm and control arm
timeFrame: before treatment, and 5 weeks, 6 months, 12 months and 24 months after intervention commencement
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: INRCA Research Hospital
city: Fermo
country: Italy
facility: INRCA Research Hospital
Study officials:
affiliation: IRCCS-INRCA
name: Giovanni Riccardi
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.