Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
ID06649500

Comparison Between Sensorized Treadmill and Conventional Therapy for Balance Disorders Using Artificial Intelligence to Identify Fall Risk in Older Adults

Led by Fondazione Policlinico Universitario Campus Bio-Medico · Updated on 2025-03-19

108

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Falls are a major cause of disability and hospitalization in people over 60, significantly affecting quality of life and healthcare costs. This research aims to compare the effectiveness of rehabilitation using a sensorized treadmill called Walker View with conventional group therapy to reduce fall risk and improve daily activities in people with balance disorders. The study also explores using Artificial Intelligence to identify early signs that predict and help prevent falls in the elderly. Participants will be randomly assigned to one of three groups: one group will use the Walker View treadmill, which provides 3D visual feedback to help improve balance through 18 sessions of 30 minutes each; another group will receive conventional group therapy for balance rehabilitation with the same number of sessions; the third group will have clinical monitoring and educational support without active treatment. Treatments focus on enhancing coordination and balance. During the study, participants will be evaluated at baseline, 6 weeks, and 10 weeks for changes in walking step length, balance, mobility, fall risk, daily living activities, muscle strength, quality of life, and stability. These assessments will include gait analysis and various physical and patient-reported measures. The study uses double-blind methods and will monitor progress to identify the best rehabilitation approach.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 years or older
  • Consent to participate in the study
  • Positive history of balance disorders
  • Absence of cognitive deficits (Mini Mental State Examination score 24 or higher)
  • Tinetti score less than 25 indicating balance impairment
Not Eligible

You will not qualify if you...

  • Musculoskeletal, cardiovascular, cerebrovascular, neuro-psychic problems, or post-surgical conditions preventing evaluation tests
  • Inability to perform a walking test
  • History of more than one fall in the last six months
  • Lack of informed consent to participate in the study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 6 weeks

Participants undergo one of the following treatments: sensorized treadmill therapy with continuous feedback to improve balance, conventional group therapy for balance re-education, or clinical monitoring with educational intervention without active treatment.

18 treatment sessions, each lasting 30 minutes

Follow-up

Duration - Up to 4 weeks after treatment

Participants are assessed for changes in gait, balance, mobility, risk of falling, daily living activities, muscle strength, quality of life, and stability after treatment.

Assessments at 6 weeks and 10 weeks from baseline

Trial Site Locations

Total: 1 location

1

Policlinico Universitario Campus Bio Medico di Roma

Rome, Rome, Italy, 00128

Actively Recruiting

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Research Team

F

Federica Bressi, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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