An interventional study of Technological intervention arm and Control arm in Stroke, Aging Problems and Innovative Rehabilitation Treatment Based on Robotics, sponsored by Istituto Nazionale di Ricovero e Cura per Anziani. Status unknown at 2 sites in Italy. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Istituto Nazionale di Ricovero e Cura per Anziani · Not applicable, Interventional, and Treatment
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.
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.
7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's planned enrollment of 150 is above the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Istituto Nazionale di Ricovero e Cura per Anziani is the lead sponsor of 42 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
Twenty technological treatment sessions divided into 3 training sessions per week for 7 weeks.
Other: Technological intervention arm
Twenty traditional treatment sessions divided into 3 training sessions per week for 7 weeks.
Other: Control arm
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)
Each session will include 50 minutes of traditional physical rehabilitation therapy
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.
Time frame: before treatment, at the end of rehabilitation sessions and 6 months, 12 months and 24 months after intervention
difference in gait performance between experimental arm and control arm
gait performance will be evaluated by the walking speed evaluated by instrumental gait analysis
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
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, 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
Time frame: before treatment, at the end of rehabilitation sessions and 6 months, 12 months and 24 months after intervention
Plan to share: No
Started Feb 2021 (actual). Primary completion is estimated for Mar 2024, 37 months after the start.
Of 2,859 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 37 months is above that.
Counting every sponsor, half of 2,988 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Istituto Nazionale di Ricovero e Cura per Anziani