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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

ConditionsBalance DisordersRehabilitationFallsFalls PreventionArtificial Intelligence (AI)Elderly (people Aged 65 or More)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorFondazione Policlinico Universitario Campus Bio-Medico

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 65 years

Consent to participate in the study

Positive history of balance disorders

Absence of cognitive deficits (MMSE ≥ 24)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Treadmill

    Other intervention

    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

    Other intervention

    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.

Treatment groups

108 Participants
are divided into 3 treatment groups
Group A: Experimental Sensorized TreadmillExperimental treatment 1 intervention
Group B: Conventional TherapyActive comparator 1 intervention
Group C: Clinical monitoringNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Policlinico Universitario Campus Bio-Medico

Lead sponsor

Source ClinicalTrials.gov
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