Innovative Models in the Rehabilitation of the Elderly With Hip Fractures Through Technological Innovation
Primary Purpose
Hip Fractures, Frail Elderly, Robotic Rehabilitation
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
traditional rehabilitation
virtual reality games intervention
robotic treadmill intervention
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures focused on measuring hip fracture, rehabilitation, robotics
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.
Sites / Locations
- INRCA Research HospitalRecruiting
- INRCA Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
control group
virtual reality games arm
robotic treadmill arm
Arm Description
Ten traditional physical treatment sessions divided into 2 training sessions per week for 5 weeks
Ten technological treatment sessions divided into 2 training sessions per week for 5 weeks.
Ten traditional physical treatment sessions divided into 2 training sessions per week for 5 weeks.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
difference in gait performance among virtual reality games arm, robotic treadmill arm and control arm
gait performance will be evaluated by the walking speed evaluated by instrumental gait analysis
difference in fear of falling among virtual reality games arm, robotic treadmill arm and control arm
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)
Full Information
NCT ID
NCT04095338
First Posted
September 16, 2019
Last Updated
October 20, 2023
Sponsor
Istituto Nazionale di Ricovero e Cura per Anziani
1. Study Identification
Unique Protocol Identification Number
NCT04095338
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 26, 2019 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Nazionale di Ricovero e Cura per Anziani
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Frail Elderly, Robotic Rehabilitation
Keywords
hip fracture, rehabilitation, robotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
195 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Ten traditional physical treatment sessions divided into 2 training sessions per week for 5 weeks
Arm Title
virtual reality games arm
Arm Type
Experimental
Arm Description
Ten technological treatment sessions divided into 2 training sessions per week for 5 weeks.
Arm Title
robotic treadmill arm
Arm Type
Experimental
Arm Description
Ten traditional physical treatment sessions divided into 2 training sessions per week for 5 weeks.
Intervention Type
Other
Intervention Name(s)
traditional rehabilitation
Intervention Description
Each session will include 50 minutes of traditional physical rehabilitation therapy
Intervention Type
Other
Intervention Name(s)
virtual reality games intervention
Intervention Description
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
Intervention Name(s)
robotic treadmill intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
difference in falling risk among virtual reality games arm, robotic treadmill arm and control arm
Description
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
Time Frame
before treatment, and 5 weeks, 6 months, 12 months and 24 months after intervention commencement
Secondary Outcome Measure Information:
Title
difference in gait performance among virtual reality games arm, robotic treadmill arm and control arm
Description
gait performance will be evaluated by the walking speed evaluated by instrumental gait analysis
Time Frame
before treatment, and 5 weeks, 6 months, 12 months and 24 months after intervention commencement
Title
difference in fear of falling among virtual reality games arm, robotic treadmill arm and control arm
Description
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)
Time Frame
before treatment, and 5 weeks, 6 months, 12 months and 24 months after intervention commencement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberta Bevilacqua
Phone
00390718004767
Email
r.bevilacqua@inrca.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Riccardi
Organizational Affiliation
IRCCS-INRCA
Official's Role
Principal Investigator
Facility Information:
Facility Name
INRCA Research Hospital
City
Ancona
ZIP/Postal Code
60131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elvira Maranesi
Email
e.maranesi@inrca.it
First Name & Middle Initial & Last Name & Degree
Giovanni Riccardi
Facility Name
INRCA Research Hospital
City
Fermo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentina Di Donna
Email
v.didonna@inrca.it
First Name & Middle Initial & Last Name & Degree
Pietro Scendoni
12. IPD Sharing Statement
Citations:
PubMed Identifier
36070134
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.
Results Reference
derived
PubMed Identifier
32546491
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.
Results Reference
derived
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Innovative Models in the Rehabilitation of the Elderly With Hip Fractures Through Technological Innovation
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