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 | Recruiting

• 2 other identifiers: 180.24 CET2cbmPNC0000007
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Step Length of Gait Analysis

  The Gait Analysis is used to assess individuals with conditions that affect their ability to walk. It is a useful test for studying gait, thanks to instruments that measure the load on each limb and walking in general. It allows us to evaluate progresses at different time frames.

  Baseline, 6 weeks, 10 weeks

Secondary Outcomes (8)

• Balance

  Baseline, 6 weeks, 10 weeks

• Mobility

  Baseline, 6 weeks, 10 weeks

• Risk of falling

  Baseline, 6 weeks, 10 weeks

• Daily Living

  Baseline, 6 weeks, 10 weeks

• Instrumental Activites of Daily Living

  Baseline, 6 weeks, 10 weeks

Study Arms (3)

Experimental Sensorized Treadmill

EXPERIMENTAL

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

Other: Treadmill

Conventional Therapy

ACTIVE COMPARATOR

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.

Other: conventional therapy

Clinical monitoring

NO INTERVENTION

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.

Interventions

Treadmill OTHER

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.

Experimental Sensorized Treadmill

conventional therapy OTHER

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.

Conventional Therapy

Eligibility Criteria

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

You may qualify if:

• Age ≥ 65 years
• Consent to participate in the study
• Positive history of balance disorders
• Absence of cognitive deficits (MMSE ≥ 24)
• Tinetti \< 25

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Campus Bio-Medico: lead

Study Sites (1)

Policlinico Universitario Campus Bio Medico di Roma

Rome, Rome, 00128, Italy

RECRUITING

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Central Study Contacts

Federica Bressi, MD

CONTACT

+39 0622541624; f.bressi@policlinicocampus.it

Study Design

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

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 18, 2024
• Study Start: December 4, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

IT (1)