Rehabilitation for elderly patients with hip fractures using robotic technology
Assistive Robotic in the Elderly: Innovative Models in the Rehabilitation of the Elderly With Hip Fractures Through Technological Innovation
NA · Istituto Nazionale di Ricovero e Cura per Anziani · NCT04095338
This study is testing if using robotic technology during rehab can help older adults recover better from hip fractures compared to regular rehab methods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 195 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Istituto Nazionale di Ricovero e Cura per Anziani (other) |
| Locations | 2 sites (Ancona and 1 other locations) |
| Trial ID | NCT04095338 on ClinicalTrials.gov |
What this trial studies
This study aims to improve rehabilitation outcomes for elderly patients who have suffered hip fractures by utilizing robotic devices alongside traditional rehabilitation methods. A total of 195 patients will be randomly assigned to receive either standard rehabilitation or robotic-assisted rehabilitation, with assessments conducted at multiple time points over two years. The focus is on enhancing balance, walking ability, and overall recovery through innovative technological interventions. The study will evaluate both immediate and long-term effects of the rehabilitation approaches.
Who should consider this trial
Good fit: Ideal candidates are elderly individuals who have experienced a hip fracture within the last 60 days and have the capacity to consent.
Not a fit: Patients with severe neurological conditions, significant disabilities affecting mobility, or those unable to participate in follow-up assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery and quality of life for elderly patients recovering from hip fractures.
How similar studies have performed: While robotic rehabilitation is an emerging field, similar studies have shown promising results in improving rehabilitation outcomes, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ancona and 1 other locations
- INRCA Research Hospital — Ancona, Italy (RECRUITING)
- INRCA Research Hospital — Fermo, Italy (RECRUITING)
Study contacts
- Principal investigator: Giovanni Riccardi — IRCCS-INRCA
- 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.
Conditions: Hip Fractures, Frail Elderly, Robotic Rehabilitation, hip fracture, rehabilitation, robotics