StrokeNCT04087083
Innovative Models in the Rehabilitation of the Elderly With Stroke Through Technological Innovation
A study testing Technological intervention arm in people with Stroke and Aging Problems, run by Istituto Nazionale di Ricovero e Cura per Anziani at 2 sites in Italy.
Trial summary
The final goal of the present study is to propose a new approach and an innovative therapeutic plan in the post-stroke rehabilitation of elderly patients, focused on the use of robotic device, in order to obtain the beneficial effects of this treatment. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Stroke, Aging Problems, Innovative Rehabilitation Treatment Based on Robotics
- What is being tested?
- Technological intervention arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesItaly
- Study dates
- 15 Feb 2021to 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
- Ischemic or hemorrhagic stroke within 3 months to the recruitment, proven by computerized axial tomography or nuclear magnetic resonance
- Functional Ambulation Category (FAC) score ≤ 2
- Ranking scale score ≤ 3
- Complete communication and comprehension skills, assessed during the objective examination
- Ability to stand upright, supported or unsupported, for 1 minute
Who cannot join
- Concomitant participation in other studies
- Severe hypertonus of the hip, knee, ankle of the paretic leg with a modified Ashworth scale score ≥3
- Severe hip, knee or ankle contracture or orthopedic problem affecting ambulation that would preclude passive range of motion of the paretic leg
- Deep vein thrombosis of the lower limbs
- Other cognitive, motor and sensory deficits that negatively condition robotic training
- Treatment of spasticity of the lower limb within 3 months to the start of the study or during the study
Show all 9Show fewer
- Lack of written informed consent
- Clinical dementia rating (CDR) score ≥ 3
- Severe systemic diseases with life expectancy < 1 year
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS INRCA Hospital
Ancona, 60131
Elvira Maranesi, e.maranesi@inrca.it
Giovanni R Riccardi, MD
- Not yet recruiting
IRCCS INRCA Hospital
Fermo
Valentina Di Donna, v.didonna@inrca.it
Pietro Scendoni, MD
About this study
Official title: Assistive Robotic in the Elderly: Innovative Models in the Rehabilitation of the Elderly With Stroke Through Technological Innovation
The final goal of the present study is to propose a new approach and an innovative therapeutic plan in the post-stroke rehabilitation of elderly patients, focused on the use of robotic device, in order to obtain the beneficial effects of this treatment.
Read the detailed description
Stroke is a leading cause of disability, injury, and death in elderly people and represents a major public health problem with substantial medical and economic consequences. The incidence of stroke rapidly increases with age, doubling for each decade after age 55 years. Gait impairment is one of the most important problems after stroke and improve walking function is often a key component of any rehabilitation program. To achieve this goal, robotic gait trainer seems to be promising. In fact, some studies underline the efficacy of robotic gait training based on end-effector technology, for different diseases, in particular in stroke patients. In this randomized controlled trial, we verify the efficacy of the robotic treatment in terms of improving the gait and reducing the risk of falling and its long-term effects.
In this single blind randomized controlled trial the investigators will include 150 elderly subacute stroke patients divided in two groups to receive a traditional rehabilitation program or a robotic rehabilitation using G-EO system, an end-effector device for the gait rehabilitation, in addition to the traditional therapy. 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, using G-EO system, will carry out 30 minutes of traditional therapy and 20 minutes of treatment with a robotic system. The primary outcome of the study is the evaluation of the falling risk. Secondary outcomes are the assessment of the gait improvements and the fear of falling. Further evaluations, such as length and asymmetry of the step, walking and functional status, acceptance of the technology, will be carried.
- Being tested
- Technological intervention arm, Control arm
- Keywords
- stroke, robotic rehabilitation, frail elderly, gait performance, balance, risk of falling, quality of life
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technological intervention armOther
Each session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic training (G-EO system, Reha Technology, Switzerland), an end-effector technology that simulates floor walking and stairs climbing (up and down)
Control armOther
Each session will include 50 minutes of traditional physical rehabilitation therapy
| Study group | Role | What they receive |
|---|---|---|
| technological intervention arm | Experimental | Twenty technological treatment sessions divided into 3 training sessions per week for 7 weeks. Receives: Other: Technological intervention arm |
| Control arm | Active comparator | Twenty traditional treatment sessions divided into 3 training sessions per week for 7 weeks. Receives: Other: Control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in falling risk between experimental arm and control arm
falling risk will be evaluated by the Tinetti performance oriented mobility assessment (POMA). Balance section of Tinetti Performance Oriented Mobility Assessment (Tinetti Performance Oriented Mobility Assessment has two subscales, Balance and Gait section.) Balance section has 9 items. Each item can be scored in a 3 point ordinal scale (0-2). "0" indicates the lowest level of function and "2" the highest level of function. Total Score = 16. Total score is obtained by adding the individual scores.
Measured: before treatment, at the end of rehabilitation sessions and 6 months, 12 months and 24 months after intervention
Secondary outcomes (3)
difference in gait performance between experimental arm and control arm
gait performance will be evaluated by the walking speed evaluated by instrumental gait analysis
Measured: before treatment, at the end of rehabilitation sessions and 6 months, 12 months and 24 months after intervention
difference in fear of falling between experimental 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, at the end of rehabilitation sessions and 6 months, 12 months and 24 months after intervention
difference in quality of life between experimental arm and control arm: SF-12 health survey
Quality of life will be measured using the Hausa SF-12 Health Survey (SF-12-H). The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health
Measured: before treatment, at the end of rehabilitation sessions and 6 months, 12 months and 24 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start15 Feb 2021
- 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 (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087083
- Sponsor's protocol ID
- INRCA-01-2019
- Status last verified
- Oct 2023
- First submitted
- 10 Sep 2019
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maranesi E, Bevilacqua R, Di Rosa M, Pelliccioni G, Di Donna V, Luzi R, Morettini M, Sbrollini A, Casoni E, Rinaldi N, Baldoni R, Lattanzio F, Burattini L, Riccardi GR. An innovative training based on robotics for older people with subacute stroke: study protocol for a randomized controlled trial. Trials. 2021 Jun 14;22(1):400. doi: 10.1186/s13063-021-05357-8.
PubMed 34127032
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 Stroke Through Technological Innovation
- ClinicalTrials.gov ID
- NCT04087083
- Acronym / sponsor ID
- INRCA-01-2019
- Keywords
- stroke, robotic rehabilitation, frail elderly, gait performance, balance, risk of falling, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 12 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 goal of the present study is to propose a new approach and an innovative therapeutic plan in the post-stroke rehabilitation of elderly patients, focused on the use of robotic device, in order to obtain the beneficial effects of this treatment.
Detailed description
Stroke is a leading cause of disability, injury, and death in elderly people and represents a major public health problem with substantial medical and economic consequences. The incidence of stroke rapidly increases with age, doubling for each decade after age 55 years. Gait impairment is one of the most important problems after stroke and improve walking function is often a key component of any rehabilitation program. To achieve this goal, robotic gait trainer seems to be promising. In fact, some studies underline the efficacy of robotic gait training based on end-effector technology, for different diseases, in particular in stroke patients. In this randomized controlled trial, we verify the efficacy of the robotic treatment in terms of improving the gait and reducing the risk of falling and its long-term effects.
In this single blind randomized controlled trial the investigators will include 150 elderly subacute stroke patients divided in two groups to receive a traditional rehabilitation program or a robotic rehabilitation using G-EO system, an end-effector device for the gait rehabilitation, in addition to the traditional therapy. 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, using G-EO system, will carry out 30 minutes of traditional therapy and 20 minutes of treatment with a robotic system. The primary outcome of the study is the evaluation of the falling risk. Secondary outcomes are the assessment of the gait improvements and the fear of falling. Further evaluations, such as length and asymmetry of the step, walking and functional status, acceptance of the technology, will be carried.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| technological intervention arm | Experimental | Other: Technological intervention armTwenty technological treatment sessions divided into 3 training sessions per week for 7 weeks. |
| Control arm | Active comparator | Other: Control armTwenty traditional treatment sessions divided into 3 training sessions per week for 7 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Capacity to consent
- Ischemic or hemorrhagic stroke within 3 months to the recruitment, proven by computerized axial tomography or nuclear magnetic resonance
- Functional Ambulation Category (FAC) score ≤ 2
- Ranking scale score ≤ 3
- Complete communication and comprehension skills, assessed during the objective examination
Key exclusion criteria (9 listed)
- Concomitant participation in other studies
- Severe hypertonus of the hip, knee, ankle of the paretic leg with a modified Ashworth scale score ≥3
- Severe hip, knee or ankle contracture or orthopedic problem affecting ambulation that would preclude passive range of motion of the paretic leg
- Deep vein thrombosis of the lower limbs
- Other cognitive, motor and sensory deficits that negatively condition robotic training
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 |
|---|---|---|
| Technological intervention armEach session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic training (G-EO system, Reha Technology, Switzerland), an end-effector technology that simulates floor walking and stairs climbing (up and down) | Other | technological intervention arm |
| Control armEach session will include 50 minutes of traditional physical rehabilitation therapy | Other | Control arm |
Primary outcome
difference in falling risk between experimental arm and control arm
Time frame: before treatment, at the end of rehabilitation sessions and 6 months, 12 months and 24 months after intervention
falling risk will be evaluated by the Tinetti performance oriented mobility assessment (POMA). Balance section of Tinetti Performance Oriented Mobility Assessment (Tinetti Performance Oriented Mobility Assessment has two subscales, Balance and Gait section.) Balance section has 9 items. Each item can be scored in a 3 point ordinal scale (0-2). "0" indicates the lowest level of function and "2" the highest level of function. Total Score = 16. Total score is obtained by adding the individual scores.
3 secondary outcomes
difference in gait performance between experimental arm and control arm
Time frame: before treatment, at the end of rehabilitation sessions and 6 months, 12 months and 24 months after intervention
difference in fear of falling between experimental arm and control arm
Time frame: before treatment, at the end of rehabilitation sessions and 6 months, 12 months and 24 months after intervention
difference in quality of life between experimental arm and control arm: SF-12 health survey
Time frame: before treatment, at the end of rehabilitation sessions and 6 months, 12 months and 24 months after intervention
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 34127032Maranesi E, Bevilacqua R, Di Rosa M, Pelliccioni G, Di Donna V, Luzi R, Morettini M, Sbrollini A, Casoni E, Rinaldi N, Baldoni R, Lattanzio F, Burattini L, Riccardi GR. An innovative training based on robotics for older people with subacute stroke: study protocol for a randomized controlled trial. Trials. 2021 Jun 14;22(1):400. doi: 10.1186/s13063-021-05357-8.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technological intervention arm in people with Stroke and Aging Problems, 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 6 inclusion and 9 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 between experimental arm and control arm (time frame: before treatment, at the end of rehabilitation sessions and 6 months, 12 months and 24 months after intervention). 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 NCT04087083, which also lists 1 linked publication.
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.