Robotic rehabilitation for elderly stroke patients
Assistive Robotic in the Elderly: Innovative Models in the Rehabilitation of the Elderly With Stroke Through Technological Innovation
This study is testing if a robotic device can help older stroke patients walk better and reduce their chances of falling compared to regular rehab programs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Istituto Nazionale di Ricovero e Cura per Anziani Academic / other |
| Locations | 2 sites (Ancona and 1 other locations) |
| Trial ID | NCT04087083 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a robotic gait training device, the G-EO system, in improving walking function and reducing fall risk in elderly patients recovering from stroke. A total of 150 participants will be randomly assigned to either a traditional rehabilitation program or a robotic-assisted rehabilitation program, with both groups receiving 20 treatment sessions over 7 weeks. The study will assess the impact of robotic therapy on gait performance and overall rehabilitation outcomes compared to standard care.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly individuals who have experienced an ischemic or hemorrhagic stroke within the last three months and have limited ambulation capabilities.
Not a fit: Patients with severe mobility impairments, cognitive deficits, or other conditions that prevent participation in robotic training may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance rehabilitation outcomes for elderly stroke patients, improving their mobility and quality of life.
How similar studies have performed: Previous studies have shown promising results with robotic gait training in stroke rehabilitation, indicating that this approach has potential based on existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Lack of written informed consent * Clinical dementia rating (CDR) score ≥ 3 * Severe systemic diseases with life expectancy \< 1 year
Where this trial is running
Ancona and 1 other locations
- IRCCS INRCA Hospital — Ancona, Italy (Recruiting)
- IRCCS INRCA Hospital — Fermo, Italy (Not_yet_recruiting)
Study contacts
- Study coordinator: Roberta Bevilacqua
- Email: r.bevilacqua@inrca.it
- Phone: 00390718004767
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.