Robot-assisted physical training for older patients in the hospital
ROBot Assisted Physical Training of Older Patients During acUte hospitaliSaTion (ROBUST) - a Randomised Controlled Trial
This study tests if using robot-assisted physical training can help older patients in the hospital stay strong and avoid losing their ability to move around after they leave.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 488 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 1 site (Svendborg) |
| Trial ID | NCT05782855 on ClinicalTrials.gov |
What this trial studies
This study investigates whether robot-assisted physical training can prevent functional decline in older patients during acute hospitalization. It is a blinded randomized controlled trial involving 488 geriatric patients who will be assigned to either active robot-assisted strength training or passive sham training, alongside usual care. The primary outcome is functional decline, measured using the Barthel Index and a 30-second chair stand test, with follow-ups at one and three months post-discharge. Secondary outcomes include quality of life, depression, fear of falling, cognition, and healthcare costs.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 65 and above who are able to ambulate before hospitalization and have an expected length of stay of at least two days.
Not a fit: Patients who can ambulate independently during hospitalization or have severe dementia or other contraindications to robot training may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the functional outcomes and quality of life for older patients during and after hospitalization.
How similar studies have performed: While the use of robotic assistance in rehabilitation is gaining interest, this specific approach in acute hospitalization for older patients is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥65 years of age * Able to ambulate before hospitalisation (with/without assistance) * Able to communicate with the research team * Expected length of stay ≥2 days * Residing on Funen, Denmark Exclusion Criteria: * Able to ambulate without assistance during current hospitalisation * Known severe dementia * Positive Confusion and Assessment Method score (20) * Patients who have received less than 3 training sessions at discharge * Terminal illness * Recent major surgery or lower extremity bone fracture in the last 3 months * Conditions contradicting use of ROBERT (unstable vertebral-, pelvic, or lower extremity fractures; high intracranial pressure; pressure ulcers or risk of developing pressure ulcers due to fragile skin; patients with medical instability) * Metastases at femur or hip * Deemed not suitable for mobilization sessions with the robot by the healthcare professional * If the patient weighs more than 165 kg (the robot cannot lift the leg if the patient is severely overweight)
Where this trial is running
Svendborg
- Odense University Hospital/Svendborg Hospital — Svendborg, Denmark (Recruiting)
Study contacts
- Principal investigator: Jesper Ryg, Professor — Department of geriatric medicine Odense University hospital, Denmark
- Study coordinator: Ann Sophia Bertelsen, PhD student
- Email: ann.sophia.bertelsen@rsyd.dk
- Phone: +4529631326
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.