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)

March 17, 2025 updated by: Federica Bressi, Fondazione Policlinico Universitario Campus Bio-Medico

Comparison Between Treatment with Sensorized Treadmill and Conventional Therapy in Balance Disorders and Use of Artificial Intelligence in Identifying Predictive and Prognostic Indices of the Risk of Falling in Balance Disorders in Adult-elderly Subjects

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Rome, Italy, 00128
        • Recruiting
        • Policlinico Universitario Campus Bio Medico di Roma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: 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.
Active Comparator: 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.
Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Step Length of Gait Analysis
Time Frame: Baseline, 6 weeks, 10 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance
Time Frame: Baseline, 6 weeks, 10 weeks

Balance will be assessed through the Tinetti Scale, a validated tool to measure balance skills, including risk of falls and walking in elderly subjects.

Each item is given a score ranging from 0 to 2, where zero equals inability, 1 ability with aid or adaptation and 2 complete ability. A lower score indicates lower capabilities. A score < or equal to 18 indicates high risk of falling, 19-24 indicates medium risk of falling, > or equal to 25 low risk of falling.
Baseline, 6 weeks, 10 weeks
Mobility
Time Frame: Baseline, 6 weeks, 10 weeks
Mobility is assessed through the Time Up and Go Test that measures the level of mobility and requires static and dynamic balancing skills to perform the test
Baseline, 6 weeks, 10 weeks
Risk of falling
Time Frame: Baseline, 6 weeks, 10 weeks
Risk of falling is assessed through the Berg Scale used to assess balance and the risk of falling. 14 items will be evaluated, each item assigns a score from 0 to 4 (with 0 = unable to perform the task, 4 = able to perform the task within the times and conditions indicated). Scores below 20 points indicate the need for the patient to use a wheelchair or aids; scores between 21 and 45 suggest using an aid when walking; scores above 45 suggest patients are able to move safely without the need of aids.
Baseline, 6 weeks, 10 weeks
Daily Living
Time Frame: Baseline, 6 weeks, 10 weeks
Daily Living is assessed with the Barthel Index for Activities of Daily Living. It is an ordinal scale which measures a persons ability to complete activities of daily living (ADL) and it assesses functional independence. The scale assigns one point for each independent function in order to obtain a total performance result that varies from 0 (complete dependence) to 6 (independence in all functions).
Baseline, 6 weeks, 10 weeks
Instrumental Activites of Daily Living
Time Frame: Baseline, 6 weeks, 10 weeks
These activities will be assessed through the IADL scale and it respectively investigates the ability of elderly subjects to carry out fundamental functions of daily life. One point will be assigned for each independent function in order to obtain a total performance result that varies from 0 (complete dependence) to 8 (independence in all functions)
Baseline, 6 weeks, 10 weeks
Muscle strength
Time Frame: Baseline, 6 weeks, 10 weeks
This will be assessed with the Motricity Index which aims to measure muscle strength and motor skills at the limb level.
Baseline, 6 weeks, 10 weeks
Patient reported Quality of Life
Time Frame: Baseline, 6 weeks, 10 weeks
This will be assessed by the QoL scale SF-36. It measures 36 items in order to objectify to quantify health status and measure health-related quality of life. The aggregate scores for each domain range from 0 to 100, as a percentage, where the higher the score, the more favorable the health status.
Baseline, 6 weeks, 10 weeks
Stability
Time Frame: Baseline, 6 weeks, 10 weeks
This outcome measure will be assessed with the stabilometric platform, which measures the average position of the body's centre of gravity and its small movements around that position.
Baseline, 6 weeks, 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Campus Bio-Medico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

October 14, 2024

First Submitted That Met QC Criteria

October 17, 2024

First Posted (Actual)

October 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 180.24 CET2cbm
  • PNC0000007 (Other Grant/Funding Number: Ministry of University and Research of Italy)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rehabilitation

Clinical Trials on Treadmill

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe