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 (UAI)

Fondazione Policlinico Universitario Campus Bio-Medico

Status: Enrolling

Conditions: Rehabilitation; Elderly (people Aged 65 or More); Balance Disorders; Falls; Falls Prevention; Artificial Intelligence (AI)

Treatments: Other: Treadmill; Other: conventional therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06649500

PNC0000007 (Other Grant/Funding Number)

180.24 CET2cbm

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 3 patient groups

Experimental Sensorized Treadmill

Experimental group

Description:

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

Treatment:

Other: Treadmill

Conventional Therapy

Active Comparator group

Description:

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.

Treatment:

Other: conventional therapy

Clinical monitoring

No Intervention group

Description:

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.