Technology-based cognitive-motor rehabilitation for frail older adults
An Integrated and Multi-perspective Approach to Cognitive-motor Technology Rehabilitation and Telemedicine in Frail Individuals
NA · Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07292428
This trial tests whether a combination of outpatient robotic therapy and asynchronous home telerehabilitation can help frail older adults with sensorimotor or cognitive problems do motor-and-thinking tasks better and reduce related risks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 65 Years to 90 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 2 sites (Rome, Italy and 1 other locations) |
| Trial ID | NCT07292428 on ClinicalTrials.gov |
What this trial studies
The project compares a technology-enhanced rehabilitation program—using a robotic platform in outpatient sessions plus asynchronous telerehabilitation at home with visual, auditory, and tactile feedback—to conventional rehabilitation in older adults with chronic sensorimotor and/or cognitive deficits. Participants are aged 65–90, able to follow simple commands and to walk independently or with minimal assistance, and will receive personalized protocols adapted to their clinical status. Outcomes focus on dual-task (motor + cognitive) performance, functional mobility, and quality-of-life measures, with remote monitoring to support adherence in the home setting. The approach emphasizes scalability by using asynchronous telerehabilitation to extend access to patients who face travel or geographic barriers.
Who should consider this trial
Good fit: Ideal candidates are 65–90 years old with chronic sensorimotor and/or cognitive impairments who can follow simple instructions (Token Test ≥ 26.5), walk independently or with minimal assistance, and can give informed consent.
Not a fit: Patients unlikely to benefit include those with cardiac, neurological, systemic, oncological, major orthopedic or postural conditions that make walking risky, active foot amputations or ulcers, or those unable to provide informed consent or follow simple commands due to severe cognitive impairment.
Why it matters
Potential benefit: If successful, this approach could improve patients' ability to perform combined motor and cognitive tasks, lower fall risk, and expand access to tailored rehabilitation at home.
How similar studies have performed: Previous work shows dual-task training and telerehabilitation can improve attention and function in older adults, but combining outpatient robotics with asynchronous home telerehabilitation is relatively novel and evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 65 and 90 years; * Presence of chronic sensorimotor and/or cognitive disabilities; * Cognitive abilities that allow the patient to carry out simple orders and understand the physiotherapist's instructions \[assessed using the Token Test (score ≥ 26.5)\]; * Ability to walk independently or with minimal assistance; * Ability to understand and sign the informed consent form. Exclusion Criteria: * Presence of systemic, neurological, or cardiac conditions that make walking risky or cause motor deficits; * Oncological conditions, orthopedic or postural problems, presence of plantar ulcers; * Partial or total amputation of segments of the foot. * Inability to provide informed consent.
Where this trial is running
Rome, Italy and 1 other locations
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome, Italy, Italy (RECRUITING)
- Poliambulatorio Moderata Durant — Vibo Valentia, VV, Italy (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Silvia Giovannini, PhD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Silvia Giovannini, MD, PhD
- Email: silvia.giovannini@policlinicogemelli.it
- Phone: +390630154382
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: Frail, Sensorimotor Deficits, Frailty, Sensorimotor impairment, Technology rehabilitation, Dual-task condition