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
NCT ID: NCT06649500
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
108 participants
INTERVENTIONAL
2024-12-04
2026-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental Sensorized Treadmill
Patients will carry out treatment with a sensorized treadmill, Walker View. This treadmill gives the possibility to patients to see their image reconstructed in a 3D mode in order to observe the bad aligments that increase the patients balance disorders. The feedback systems are necessary to give continuous stimulation to the patients.
Each patients will carry out 18 treatment sessions and each session will last 30 minutes
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
Patients in this arm will carry out treatment with a conventional group therapy, consisting in usual treatment according to current clinical practice.
Each patient will undergo 18 sessions of conventional therapy based on group re-education.
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.
Clinical monitoring
Patients in this arm will take part in the 'no intervention' part of the study and they will not carry out treatment. Patients will undergo only a clinical monitoring with an educational intervention, which does not elvove treatment or exercises, and they will continue to follow their daily habits.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Consent to participate in the study
* Positive history of balance disorders
* Absence of cognitive deficits (MMSE ≥ 24)
* Tinetti \< 25
Exclusion Criteria
* 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.
65 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Campus Bio-Medico
OTHER
Responsible Party
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Federica Bressi
Professor
Locations
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Policlinico Universitario Campus Bio Medico di Roma
Rome, Rome, Italy
Countries
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Central Contacts
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Other Identifiers
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PNC0000007
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
180.24 CET2cbm
Identifier Type: -
Identifier Source: org_study_id
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