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Clinical Trials in Italy / NCT06649500
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Identify the Most Effective Rehabilitation Method Between a Treatment with a Sensorized Treadmill (Walker View) and a Treatment with Conventional Group Therapy in Balance Disorders and the Use of Artificial Intelligence to Identify Predictive Indices to Prevent Falls and Diagnose Promptly the Risk

NCT06649500 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-12-04
Last updated
2025-03-19

Condition(s) studied

Balance DisordersRehabilitationFallsFalls PreventionArtificial Intelligence (AI)Elderly (people Aged 65 or More)

Investigational drug(s) / intervention(s)

Treadmillconventional therapy

Treadmill: The Walker View system is a treadmill equipped with a loaded cell sensor belt and a 3D camera that allows you to detect every single angular movement of the subject. Furthermore, thanks to the two optics, a classic one for 2D shooting in high resolution, and a revolutionary one for infrared rays, it is possible to reconstruct the position of the subject in space in three-dimensional mode and in real time. The reflected image reconstructed by the system helps to improve movement through the \"continuous feedback system\" method.

conventional therapy: Conventional therapy intervention will follow the usual treatment according to current clinical practice. This treatment will be delivered to patients in a group session in order the balance disorders.

Study summary

Falls in the elderly are one of the main sources of disability and hospitalization, with a significant impact on quality of life and social and healthcare costs. Falls represent a significant health concern for people over 60 years old. Numerous studies have shown that falls cause serious health consequences. Around 30% of people over the age of 60 experience a fall during the year.

According to the impact falls have, the investigators decided to analyze the effectiveness of training on a Walker View sensorized treadmill, with the possibility of exercises for coordination and balance, compared to training with a conventional group therapy, in order to understand the best training to reduce the risk of falling and observe the possible improvements in daily life activities.

So the study aims to identify the most effective rehabilitation method between a treatment with a sensorized treadmill (Walker View) and a conventional group therapy in balance disorders.

The study also aims to identify predictive indices, with the use of Artificial Intelligence, that can contribute to the prevention and diagnosis of balance disorders in a short time and prevent falls in the elderly.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 65 years * Consent to participate in the study * Positive history of balance disorders * Absence of cognitive deficits (MMSE ≥ 24) * Tinetti \< 25 Exclusion Criteria: * Clinical pictures associated with musculoskeletal, cardiovascular, cerebrovascular, neuro-psychic problems and post-surgical outcomes that make the planned evaluation tests unfeasible. * Inability to carry out a walking test. * History of more than one fall in the last six months. * Subjects who have not expressed informed consent to participate in the study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Policlinico Universitario Campus Bio Medico di Roma Rome Rome Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06649500 on ClinicalTrials.gov ↗ ← All trials in Italy