An interventional study of Treadmill and conventional therapy in Balance Disorders, Rehabilitation and Falls, sponsored by Fondazione Policlinico Universitario Campus Bio-Medico. Recruiting at 1 site in Italy. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-03-19.
Sponsored by Fondazione Policlinico Universitario Campus Bio-Medico · Not applicable, Interventional, and Treatment
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.
Fondazione Policlinico Universitario Campus Bio-Medico is the lead sponsor of 29 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
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
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
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.
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.
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.
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.
Time frame: Baseline, 6 weeks, 10 weeks
Balance
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.
Time frame: Baseline, 6 weeks, 10 weeks
Mobility
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
Time frame: Baseline, 6 weeks, 10 weeks
Risk of falling
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.
Time frame: Baseline, 6 weeks, 10 weeks
Daily Living
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).
Time frame: Baseline, 6 weeks, 10 weeks
Instrumental Activites of Daily Living
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)
Time frame: Baseline, 6 weeks, 10 weeks
Muscle strength
This will be assessed with the Motricity Index which aims to measure muscle strength and motor skills at the limb level.
Time frame: Baseline, 6 weeks, 10 weeks
Patient reported Quality of Life
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.
Time frame: Baseline, 6 weeks, 10 weeks
Stability
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.
Time frame: Baseline, 6 weeks, 10 weeks
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Fondazione Policlinico Universitario Campus Bio-Medico