Cognitive-motor Technology Rehabilitation in Frail Individuals
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-90
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Technological rehabilitation with robotic platfom and home telerehabilitation device
DeviceTechnological outpatient and home rehabilitation
Conventional rehabilitation
Other interventionConventional outpatient and home rehabilitation
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Technological Group (G-Tec)Experimental treatment 1 intervention
Group B: Conventional Group (G-Con)Active comparator 1 intervention
Trial outcomes
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.
Time frame
Change from Baseline DTC at 8 weeksSecondary outcomes
1
Hand Grip Strength Test (HSGT)
HGST is a test performed with a dynamometer, which goes to assess muscle strength (in kilograms). Starting with the elbow flexed to 90° the patient must squeeze the dynamometer as hard as they can at one time. Three repeated measurements are taken on each side 20 seconds apart. The average of the three assessments is used as the final value.
Time frame
Change from Baseline HGST at 8 weeks2
Short Physical Performance Battery (SPPB)
SPPB is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults (\>65 years of age). Three domains, which include balance, usual or self-selected gait speed, and lower limb strength, are assessed by a three-stage balance test (feet side-by-side, semitandem, and tandem positions), a 3-m or 4-m gait speed test (time spent to walk the course), and a repetitive chair stand test (five times chair sit-to-stand test), respectively. A 0- to 12-point scale is used to score the sum of the three assessments with higher point values corresponding with greater levels of physical function and lower disability, whereas lower point values correspond with lower levels of physical function and higher disability, respectively.
Time frame
Change from Baseline SPPB at 8 weeks3
Timed Up and Go Test (TUG)
The Timed Up and Go test (TUG) measures in seconds the time it takes a subject to rise from a chair, walk a distance of 3 meters, turn, walk back to the chair and sit down. The performance is rated on a scale of 1 to 5 (where 1 is normal and 5 is severely abnormal) according to the observer's perception of the patient's risk of falling. The timed part of the test records the mean time (in seconds) from initial getting up to re-seating. Patients are compared with the mean time of adults in their age group, 60 to 69, 70 to 79, and 80 to 99 years of age.
Time frame
Change from Baseline TUG at 8 weeks4
Six-minute walk test (6MWT)
The 6MWT is a sub-maximal exercise test used to assess walking endurance and aerobic capacity. Participants will walk around the perimeter of a set circuit for a total of six minutes. The score of the test is the distance a patient walks in 6 minutes (measured in meters and can round to the nearest decimal point). Distance (in meters) covered in six minutes is calculated by multiplying the number of total laps by 12 meters and adding the distance of the partial lap completed at the time the test ended.
Time frame
Change from Baseline 6MWT at 8 weeksSponsors and contacts
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Source ClinicalTrials.gov