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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 108
- Locations
- 2
- Primary Endpoint
- Change in Step Length of Gait Analysis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- Muscle strength(Baseline, 6 weeks, 10 weeks)
- Patient reported Quality of Life(Baseline, 6 weeks, 10 weeks)
- Stability(Baseline, 6 weeks, 10 weeks)
Investigators
Federica Bressi
Professor
Fondazione Policlinico Universitario Campus Bio-Medico