Balance DisordersUAINCT06649500
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
A study testing Treadmill and conventional therapy in people with Balance Disorders and Rehabilitation, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Balance Disorders, Rehabilitation, Falls
- What is being tested?
- Treadmill and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteItaly
- Study dates
- 4 Dec 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years
- Consent to participate in the study
- Positive history of balance disorders
- Absence of cognitive deficits (MMSE ≥ 24)
- Tinetti \< 25
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Policlinico Universitario Campus Bio Medico di Roma
Rome, Rome, 00128
About this study
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
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.
Read more
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.
- Conditions
- Balance Disorders, Rehabilitation, Falls, Falls Prevention, Artificial Intelligence (AI), Elderly (people Aged 65 or More)
- Being tested
- Treadmill, conventional therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreadmillOther
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 therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Sensorized Treadmill | Experimental | 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 Receives: Other: Treadmill |
| Conventional Therapy | Active comparator | 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. Receives: Other: conventional therapy |
| Clinical monitoring | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks, 10 weeks
Secondary outcomes (8)
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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 weeks, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start4 Dec 2024
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federica Bressi, Fondazione Policlinico Universitario Campus Bio-Medico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649500
- Sponsor's protocol ID
- 180.24 CET2cbm
- Other IDs
- PNC0000007
- Acronym
- UAI
- Status last verified
- Mar 2025
- First submitted
- 14 Oct 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06649500
- Acronym / sponsor ID
- UAI / 180.24 CET2cbm
- Conditions
- Balance Disorders, Rehabilitation, Falls, Falls Prevention, Artificial Intelligence (AI), Elderly (people Aged 65 or More)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-MedicoUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Sensorized Treadmill | Experimental | Other: TreadmillPatients 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 |
| Conventional Therapy | Active comparator | Other: conventional therapyPatients 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. |
| Clinical monitoring | No intervention | –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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥ 65 years
- Consent to participate in the study
- Positive history of balance disorders
- Absence of cognitive deficits (MMSE ≥ 24)
- Tinetti \< 25
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreadmillThe 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. | Other | Experimental Sensorized Treadmill |
| conventional therapyConventional 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. | Other | Conventional Therapy |
Primary outcome
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill and conventional therapy in people with Balance Disorders and Rehabilitation, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federica Bressi, MD (+39 0622541624, f.bressi@policlinicocampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Step Length of Gait Analysis (time frame: Baseline, 6 weeks, 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.