Actively Recruiting
An Integrated and Multi-perspective Approach to Cognitive-motor Technology Rehabilitation and Telemedicine in Frail Individuals
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2026-02-03
80
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on frail individuals with chronic sensorimotor and/or cognitive disabilities, who often struggle to perform motor and cognitive tasks at the same time. Such difficulties can lead to increased fall risk and cognitive decline. The study aims to evaluate a new rehabilitation approach that combines robotic technology and asynchronous telerehabilitation to improve the ability to perform dual tasks and enhance quality of life for these patients. Participants will be randomly assigned to one of two groups. The first group (G-Tec) will receive four weeks of outpatient technological rehabilitation using robotic platforms (hunova and Senso), followed by four weeks of home-based telerehabilitation with a tablet containing cognitive exercises. The second group (G-Con) will receive conventional outpatient and home rehabilitation, mainly cognitive exercises provided via booklet. Both groups will then be observed for eight weeks without treatment. Throughout the study, patients will attend rehabilitation sessions three times weekly for 45 minutes during the outpatient and home phases. Researchers will assess clinical outcomes, treatment adherence, patient satisfaction, and technology acceptance. They will use multiple tests, including Dual-Task Cost, physical performance measures, cognitive assessments, and quality of life questionnaires, to evaluate changes from baseline. Data collected remotely during home telerehabilitation will monitor adherence and progress, with clinical evaluations at key timepoints over the 18-month trial.
CONDITIONS
Brief Title
Cognitive-motor Technology Rehabilitation in Frail Individuals
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 65 and 90 years
- Presence of chronic sensorimotor and/or cognitive disabilities
- Cognitive abilities allowing understanding and following simple instructions (Token Test score 26.5)
- Ability to walk independently or with minimal assistance
- Ability to understand and sign the informed consent form
You will not qualify if you...
- Presence of systemic, neurological, or cardiac conditions making walking risky or causing motor deficits
- Oncological conditions, orthopedic or postural problems, or presence of plantar ulcers
- Partial or total amputation of segments of the foot
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants undergo outpatient rehabilitation treatment for 4 weeks, 45 minutes a day, 3 times a week. Participants in the technological group use robotic and technological tools, while those in the conventional group perform similar exercises through conventional rehabilitation activities. Participant satisfaction, adherence, and acceptance of technology are assessed during this phase.
3 visits per week (in-person) for 4 weeks
Duration - 4 weeks
Participants continue rehabilitation at home for 4 weeks, 45 minutes a day, 3 times a week. The technological group uses a tablet with cognitive exercises for asynchronous telerehabilitation, while the conventional group uses a booklet of cognitive exercises. Weekly telephone contact supports adherence monitoring. Effectiveness and participant satisfaction are assessed at the end of this phase.
Weekly telephone contacts and 1 device return visit (in-person)
Duration - 8 weeks
Participants do not undergo rehabilitation treatment during this 8-week period. Effectiveness is assessed at the end of follow-up through clinical and instrumental evaluations to document maintenance of improvements.
1 visit (in-person)
Trial Site Locations
Total: 2 locations
1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Italy, Italy, 00168
Actively Recruiting
2
Poliambulatorio Moderata Durant
Vibo Valentia, VV, Italy, 89900
Not Yet Recruiting
Research Team
S
Silvia Giovannini, MD, PhD
L
Letizia Castelli, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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