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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Treadmill, conventional therapy.
- Who it may be relevant to
- Registry conditions: Balance Disorders, Rehabilitation, Falls, Falls Prevention. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- 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 \" - 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.
Primary outcome measures
- Change in Step Length of Gait Analysis [Time frame: Baseline, 6 weeks, 10 weeks]
Secondary outcome measures (8)
- Balance [Time frame: Baseline, 6 weeks, 10 weeks]
- Mobility [Time frame: Baseline, 6 weeks, 10 weeks]
- Risk of falling [Time frame: Baseline, 6 weeks, 10 weeks]
- Daily Living [Time frame: Baseline, 6 weeks, 10 weeks]
- Instrumental Activites of Daily Living [Time frame: Baseline, 6 weeks, 10 weeks]
- Muscle strength [Time frame: Baseline, 6 weeks, 10 weeks]
- Patient reported Quality of Life [Time frame: Baseline, 6 weeks, 10 weeks]
- Stability [Time frame: Baseline, 6 weeks, 10 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Policlinico Universitario Campus Bio Medico di Roma — Rome
Identifiers
NCT: NCT06649500 · 180.24 CET2cbm · PNC0000007