Hip FracturesNCT04095338
Innovative Models in the Rehabilitation of the Elderly With Hip Fractures Through Technological Innovation
A study testing traditional rehabilitation, virtual reality games intervention and robotic treadmill intervention in people with Hip Fractures and Frail Elderly, run by Istituto Nazionale di Ricovero e Cura per Anziani at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Frail Elderly, Robotic Rehabilitation
- What is being tested?
- traditional rehabilitation, virtual reality games intervention and robotic treadmill intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 2 sitesItaly
- Study dates
- 26 Nov 2019to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Capacity to consent
- Traumatic event within 60 days
- Romberg test: negative
- Functional Ambulation Category (FAC) score ≤ 2
- Ranking scale score ≤ 3;
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
INRCA Research Hospital
Ancona, 60131
Elvira Maranesi, e.maranesi@inrca.it
Giovanni Riccardi
- Recruiting
INRCA Research Hospital
Fermo
Valentina Di Donna, v.didonna@inrca.it
Pietro Scendoni
About this study
Official title: Assistive Robotic in the Elderly: Innovative Models in the Rehabilitation of the Elderly With Hip Fractures Through Technological Innovation
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.
Read the 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
- Being tested
- traditional rehabilitation, virtual reality games intervention, robotic treadmill intervention
- Keywords
- hip fracture, rehabilitation, robotics
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional rehabilitationOther
Each session will include 50 minutes of traditional physical rehabilitation therapy
virtual reality games interventionOther
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 interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Ten traditional physical treatment sessions divided into 2 training sessions per week for 5 weeks Receives: Other: traditional rehabilitation |
| virtual reality games arm | Experimental | Ten technological treatment sessions divided into 2 training sessions per week for 5 weeks. Receives: Other: virtual reality games intervention |
| robotic treadmill arm | Experimental | Ten traditional physical treatment sessions divided into 2 training sessions per week for 5 weeks. Receives: Other: robotic treadmill intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
gait performance will be evaluated by the walking speed evaluated by instrumental gait analysis
Measured: 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
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)
Measured: before treatment, and 5 weeks, 6 months, 12 months and 24 months after intervention commencement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start26 Nov 2019
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Riccardi, Principal investigator, IRCCS-INRCA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095338
- Sponsor's protocol ID
- INRCA_03_2019
- Status last verified
- Oct 2023
- First submitted
- 16 Sep 2019
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36070134Maranesi 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.
PubMed 32546491
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistive Robotic in the Elderly: Innovative Models in the Rehabilitation of the Elderly With Hip Fractures Through Technological Innovation
- ClinicalTrials.gov ID
- NCT04095338
- Acronym / sponsor ID
- INRCA_03_2019
- Conditions
- Hip Fractures, Frail Elderly, Robotic Rehabilitation
- Keywords
- hip fracture, rehabilitation, robotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: traditional rehabilitationTen traditional physical treatment sessions divided into 2 training sessions per week for 5 weeks |
| virtual reality games arm | Experimental | Other: virtual reality games interventionTen technological treatment sessions divided into 2 training sessions per week for 5 weeks. |
| robotic treadmill arm | Experimental | Other: robotic treadmill interventionTen traditional physical treatment sessions divided into 2 training sessions per week for 5 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Capacity to consent
- Traumatic event within 60 days
- Romberg test: negative
- Functional Ambulation Category (FAC) score ≤ 2
- Ranking scale score ≤ 3;
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| traditional rehabilitationEach session will include 50 minutes of traditional physical rehabilitation therapy | Other | control group |
| virtual reality games interventionEach 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). | Other | virtual reality games arm |
| robotic treadmill interventionEach 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. | Other | robotic treadmill arm |
Primary outcome
difference in falling risk among virtual reality games arm, robotic treadmill arm and control arm
Time frame: 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
2 secondary outcomes
difference in gait performance among virtual reality games arm, robotic treadmill arm and control arm
Time frame: 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
Time frame: before treatment, and 5 weeks, 6 months, 12 months and 24 months after intervention commencement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 36070134Fairhall 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.
- Derived from this study: PubMed 32546491Maranesi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Riccardi principal investigator
IRCCS-INRCA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional rehabilitation, virtual reality games intervention and robotic treadmill intervention in people with Hip Fractures and Frail Elderly, run by Istituto Nazionale di Ricovero e Cura per Anziani at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberta Bevilacqua (00390718004767, r.bevilacqua@inrca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in falling risk among virtual reality games arm, robotic treadmill arm and control arm (time frame: before treatment, and 5 weeks, 6 months, 12 months and 24 months after intervention commencement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04095338, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.