Cognitive-motor Technology Rehabilitation in Frail Individuals

NCT07292428 | Recruiting

• 1 other identifier: 7943
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Dual performance, which involves the simultaneous execution of motor and cognitive tasks, is a fundamental aspect of everyday functioning. In the elderly population, for example, the ability to manage dual tasks can be significantly impaired, resulting in an increased risk of falls and further cognitive decline. The ability to perform two tasks simultaneously (one motor and one cognitive) is often impaired in patients with chronic sensorimotor and/or cognitive disabilities, with repercussions on both physical and cognitive abilities. Patients with chronic sensorimotor and/or cognitive disabilities consistently show greater deficits in dual performance than healthy individuals, with repercussions on both motor and cognitive functioning. These deficits are influenced by psychological, neural, and disease-specific factors, but targeted interventions and dual-task training can help improve outcomes. Some authors have pointed out that dual-task training can improve attention, functional mobility, and overall cognitive function more effectively than single-task training. One of the main advantages of dual-task training is the reduction of the risk of falls in the elderly population and in chronic patients with sensorimotor disorders: dual-task training has been shown to improve dynamic balance and stability, even during walking, and cognitive function. Telerehabilitation is a branch of telemedicine that uses different types of technology to provide remote rehabilitation services. Telerehabilitation, like telemedicine, can be delivered through three distinct mechanisms: synchronous mode, in which the patient and physician communicate in real time using technological tools; remote monitoring mode, in which the patient's condition is monitored remotely; and asynchronous mode, in which there is no simultaneous communication between the parties involved. This approach has proven particularly effective during the recent COVID-19 pandemic, minimizing risks and improving clinical outcomes. In addition, it has proven to be a safe way to monitor clinical parameters, with the possibility of personalized and timely intervention for patients with chronic conditions, leading to improved patient condition and quality of life, while also helping to reduce costs for both the patient and the healthcare system. Asynchronous telemedicine and/or telerehabilitation activities, in which the patient and operator are not online at the same time, also enable patients living in remote areas with limited or unreliable connectivity to receive convenient, flexible, and accessible healthcare services.

Conditions

Frail; Sensorimotor Deficits

Keywords

Frailty; Sensorimotor impairment; Technology rehabilitation; Dual-task condition

Outcome Measures

Primary Outcomes (1)

• Dual-Task Cost (DTC)

  DTC refers to the deterioration in performance in one or both tasks when two tasks are performed simultaneously compared to when they are performed individually. This cognitive cost manifests itself as a reduction in speed, accuracy or quality in task performance, and can be measured by comparing individual performance with that achieved in "dual task" mode. Specifically, DTC is calculated as the difference between the displacement of the centre of pressure during a cognitive task and the displacement of the centre of pressure during a single-task activity with eyes open, divided by the displacement of the centre of pressure during a single-task activity with eyes open. Higher DTC values correspond to a deterioration in performance.

  Change from Baseline DTC at 8 weeks

Secondary Outcomes (16)

• Hand Grip Strength Test (HSGT)

  Change from Baseline HGST at 8 weeks

• Short Physical Performance Battery (SPPB)

  Change from Baseline SPPB at 8 weeks

• Timed Up and Go Test (TUG)

  Change from Baseline TUG at 8 weeks

• Six-minute walk test (6MWT)

  Change from Baseline 6MWT at 8 weeks

• Timed-25 Foot Walk (T25FW)

  Change from Baseline T25FW at 8 weeks

Study Arms (2)

Technological Group (G-Tec)

EXPERIMENTAL

G-Tec patients will undergo outpatient technological rehabilitation treatment for 4 weeks using hunova® and Senso robots, followed by home-based technological rehabilitation treatment for another 4 weeks using a tablet with cognitive exercises developed specifically for home cognitive treatment, followed by 8 weeks of observation.

Device: Technological rehabilitation with robotic platfom and home telerehabilitation device

Conventional Group (G-Con)

ACTIVE COMPARATOR

G-Con patients will undergo conventional outpatient rehabilitation treatment for 4 weeks, followed by conventional home-based rehabilitation treatment, mainly cognitive in nature, for another 4 weeks, and then 8 weeks of observation.

Other: Conventional rehabilitation

Interventions

Technological rehabilitation with robotic platfom and home telerehabilitation device DEVICE

Technological outpatient and home rehabilitation

Technological Group (G-Tec)

Conventional rehabilitation OTHER

Conventional outpatient and home rehabilitation

Conventional Group (G-Con)

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (2)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italy, 00168, Italy

RECRUITING

Poliambulatorio Moderata Durant

Vibo Valentia, VV, 89900, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Silvia Giovannini, PhD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Giovannini, MD, PhD

CONTACT

+390630154382; silvia.giovannini@policlinicogemelli.it

Letizia Castelli, PhD

CONTACT

letizia.castelli@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 18, 2025
• Study Start: February 2, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-02

Locations

IT (2)