FallNCT05018455
The Effectiveness of Remote Fall Prevention Program vs. Face-to-Face
A study testing Fall prevention program training based on Otago principles in people with Fall, run by University of Haifa at 2 sites in Israel.
Trial summary
Falls are a serious problem in the elderly leading to injuries, morbidity, and consequently a heavy impact on the individual suffering, and society at large. This study aims to investigate the effectiveness of a remote fall prevention program in comparison with a similar face-to-face program. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall
- What is being tested?
- Fall prevention program training based on Otago principles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 2 sitesIsrael
- Study dates
- 28 Nov 2021to 26 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- home-dwelling elderly, aged 65 years or more
- Identified to be at low to moderate risk of falling
- Risk of falling will be assessed according to a combination of subjective and objective evaluation. Subjective questions from the STEADI (stopping elderly accidents death, and injuries), an algorithm for fall risk screening, assessment, and intervention, developed by the American Center for Disease Control and Prevention, relate to (1) Feels unsteady when standing/walking, (2) Worries about falling, and (3) Has fallen no more than 3 times in the past year.
- An additional inclusion criterion is scoring 21 or more in the Mini-Best test (a balance test).
Who cannot join
- Subjects suffering from severe musculoskeletal pain or disorders that will limit completion of the assessment procedure such as pain limiting weight-bearing for no longer than a few minutes
- Unstable cardiovascular/pulmonary disease
- Unbalanced diabetes
- Neurological diseases such as stroke, Parkinson's, or multiple sclerosis
- Use of a walking aid (except for a cane)
- visual or hearing impairment that will not allow the use of technology for remote practice
Show all 9Show fewer
- A score lower than 21/30 on the Montreal Cognitive Assessment score (MoCA),
- High risk of falling on the balance test (Mini-BESTest ≤ 20)
- Comment: exclusion criteria will be based on self-report and completed at the initial baseline assessment
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
The Faculty of Social Welfare and Health Science, Haifa University
Haifa
Gold club Kfar vradim
Kfar Vradim, 2017000
About this study
Official title: The Effectiveness of Remote Fall Prevention Program vs. Face-to-Face in Low-medium Risk Elderly- A Cross Over Randomized Controlled Trial
Falls are a serious problem in the elderly leading to injuries, morbidity, and consequently a heavy impact on the individual suffering, and society at large.
This study aims to investigate the effectiveness of a remote fall prevention program in comparison with a similar face-to-face program. This study design is a randomized control trial (RCT) with a cross-over in group allocation. The population will include 106 home-dwelling elderly, aged 65 years or more, with low to moderate risk of fall. Participants will be randomized to start intervention in the remote or face-to-face group. Training will be twice weekly for 3 months, after which there will be two weeks of washout, followed by a cross-over between groups. Outcome measures will include fall rate over a year (primary measure), balance, functional testing, subjective measures of fear of falls, quality of life, satisfaction from intervention, adherence, and compliance.
Read the detailed description
The aim of the proposed study is to investigate the effectiveness of a remote fall prevention training program. The proposed intervention program includes an Otago-based fall prevention training program to improve lower extremity strength, balance, and walking, directed by physical therapists, over 6 months. The remote group will train at home, using video communication software, while the face-to-face group will train at a local community center.
The proposed study will be designed as a randomized control trial (RCT) with a cross-over design. The population will include 106 home-dwelling elderly, aged 65 years or more, walking independently, that will be identified at low to moderate risk of fall. Candidates with unbalanced systemic disease or disorders, cognitive and physical Impairments that will prevent participation in the program, will not be included. A full description of the inclusion and exclusion criteria is provided below in the Eligibility section.
Participants will be randomized into two groups that will receive similar Otago-based fall prevention group training, either remotely or face-to-face.
The training sessions: The training starts with five minutes of gentle warm-up with the same five flexibility exercises, followed by structured lower limb muscles strengthening, balance exercises, and instruction for independent walking for up to 30 minutes at least twice a week. The training will be delivered to groups of ten participants. The duration of each session will be one hour, twice a week for three months. After three months of training, there will be a two weeks break, serving as a washout period, after which the groups will switch, for another three months. At the end of the intervention period (6.5 months), each participant will be trained by both remote and face-to-face programs. Assessments will be conducted at 4-time points: baseline, 3 months after completion of the first-ordered training, 6.5 months after completion of both trainings, and 12 months follow up.
The primary outcome measure is the number of falls during a year. secondary outcome measures include Objective measures as balance, Walking speed, lower extremities functional strength, adherence, and compliance to the training program. The subjective outcome measure will include participant Satisfaction from the program, Fear of falls, and Quality of life. More details regarding outcome measures are provided below in the outcome measure section.
Statistical analysis: The equivalence test will be used to examine if the remote fall prevention training is as good as the face-to-face. In order to check if there is a period-treatment effect on the objective outcome measures we will employ a mixed-model repeated-measures analysis of variance (ANOVA): 4-time points (baseline, 3 months, 6 months, 12 months follow up) X 2 interventions (remote vs. face-to-face), counting for the fact that subjects are nested in sequence. When interaction will be significant simple mean analysis will be used to reveal a significant source. Studentized Maximum Modulus (SMM) post-hoc adjustment method will be used to reveal significance between pairs of periods.
If this study will manage to show remote fall prevention is feasible, safe, and effective, it will promote a solution in one of the most serious health problems in the elderly, in one of the most challenging eras for the elderly, when remote healthcare is vital.
- Conditions
- Fall
- Being tested
- Fall prevention program training based on Otago principles
- Keywords
- Telehealth, fall prevention, home dwelling elderly, Otago
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fall prevention program training based on Otago principlesOther
balance and strength exercises
| Study group | Role | What they receive |
|---|---|---|
| Fall prevention intervention program conducted through telehealth | Experimental | The training program is based on the principles of the Otago program, designed specifically to prevent falls. It consists set of leg muscle strengthening and balance retraining exercises progressing in difficulty, and a walking plan. The training will be delivered to a group of 10 participants. Each participant will practice from home, using a zoom system. The duration of each training will be one hour, the frequency of training will be twice a week for three months. Receives: Other: Fall prevention program training based on Otago principles |
| Similar fall prevention intervention program conducted through face to face group training | Active comparator | The training program is based on the principles of the Otago program, designed specifically to prevent falls. It consists set of leg muscle strengthening and balance retraining exercises progressing in difficulty, and a walking plan. The training will be delivered to a group of 10 participants. The training sessions will be delivered at the local community center, twice a week for one hour for three months. Receives: Other: Fall prevention program training based on Otago principles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of falls during the study period
Subjects will self-report falls weekly in a personal fall diary. This will be supported by a telephone call from one of the investigators once a month.
Measured: Falls will be monitored for one year
Secondary outcomes (11)
Mini Balance Evaluation Systems Tests
Mini Balance Evaluation Systems Tests (Mini-BESTest) is a clinical balance assessment tool. This test includes 14 items, each scored from 0 (severe balance impairment) to 2 (no balance impairment). The maximal possible score is 28 points. Higher scores indicate better balance performance. A score of 20 points or below indicates a high fall risk.
Measured: Change from baseline at 3, 6 and 12 months
Time-Up and Go Test
The Timed Up and Go Test (TUG) assesses mobility, balance, and fall risk in older adults. The test measures the time required for a subject to stand up from sitting on a chair, walk for 3 meters, turn, walk back, and sit down. A score of 12 seconds or more indicates risk of falling in community dwelling adults.
Measured: Change from baseline at 3, 6 and 12 months
Berg Balance Scale
The Berg Balance Scale (BBS) is a 14- item objective measure that assesses static and dynamic balance, and fall risk in adults. Each item is scored from 0 (unable to perform) to 4 (normal performance). The maximal possible score is 56 points. Any score from 0 to 36 indicate 100% fall risk for older adults. The Berg Balance Scale (BBS) is widely used in clinical practice to predict falls in the older adults. lately, due to ceiling effect, the use of BBS as a single measure to accurately predict future falls seems to be insufficient.
Measured: Change from baseline at 3, 6 and 12 months
Four Stage Balance Test
The 4-Stage Balance Test assess static balance at four standing positions, that get progressively harder to maintain. The person is asked to hold a position for 10 seconds without moving his feet or supporting. An older adult, who cannot hold the tandem stand, which is the forth position, for at least 10 seconds, is at increased risk of falling.
Measured: Change from baseline at 3, 6 and 12 months
Walking speed
Walking speed will be measured using the 4-Meter Walk Test in seconds. Walking speed lower than 1.0 seconds/meter is considered a strong predictor of falls in the elderly population living in the community.
Measured: Change from baseline at 3, 6 and 12 months
Lower extremities functional strength
Functional strength of the lower limbs will be measured by the 30-second Sit to Stand Test. This is also used for fall prediction. A result lower than expected by age and sex indicates a risk of falls
Measured: Change from baseline at 3, 6 and 12 months
Attendance
Attendance to the program will be recorded each class by the physiotherapist who will conduct the training. Total attendance will be defined as the number/percentage of classes attended out of the total number of sessions conducted, for example attending 75 sessions out of 100 will be calculated as total attendance of 75%.
Measured: Will be monitored and record in any session time, for 6 months
Completion (retention)
Completion of the full period of the program- 6 months, will be recorded for each participant, and will reflect retention. Non-completion will be recorded for the participants who will withdrawal from the program before the end of the program, and will not complete the 6 months, end of program, assessment.
Measured: Will be monitored and record in any session time, for 6 months
Satisfaction from program
Participant satisfaction will be assessed using a satisfaction rating scale of 0-10, with a score of 0 indicating complete dissatisfaction and a score of 10 maximum satisfaction.
Measured: Twice- after each program session (after 3 and 6 months).
Fear of falls
Fear of falls will be assessed using the Modified Falls Efficacy Scale (MFES) questionnaire, which is one of the most common and reliable research tools in fall research. In this questionnaire, the subject rates his confidence in performing 10 daily tasks
Measured: Change from baseline at 3, 6 and 12 months
12-Item Short Form Survey (SF-12) Quality of life questionnaire
Quality of life will be assessed using the SF-12 questionnaire. This questionnaire assesses the perception of quality of life through 12 questions that relate to the subject's views about his state of health and ability to perform various actions and functions. The use of this questionnaire is common in fall studies.
Measured: Change from baseline at 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start28 Nov 2021
- Primary completion26 Mar 2023
- Study completion26 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FallStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The intervention program will include Otago- based fall prevention training face-to-face or remote. Each subject will receive the two types of interventions in sequence, with a cooling-off period between them. The intervention program in this study will last 6 months, however, the intervention arm will be swapped after 3 months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- Western Galilee Hospital-Nahariya
- Responsible party
- Sponsor
- Investigators
- Hilla Sarig Bahat, PT PhD, Principal investigator, Department of Physical Therapy, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018455
- Sponsor's protocol ID
- Remote fall prevention
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2021
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sherrington C, Fairhall NJ, Wallbank GK, Tiedemann A, Michaleff ZA, Howard K, Clemson L, Hopewell S, Lamb SE. Exercise for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2019 Jan 31;1(1):CD012424. doi: 10.1002/14651858.CD012424.pub2.
PubMed 30703272Kyrdalen IL, Moen K, Roysland AS, Helbostad JL. The Otago Exercise Program performed as group training versus home training in fall-prone older people: a randomized controlled Trial. Physiother Res Int. 2014 Jun;19(2):108-16. doi: 10.1002/pri.1571. Epub 2013 Dec 11.
PubMed 24339273Bernocchi P, Giordano A, Pintavalle G, Galli T, Ballini Spoglia E, Baratti D, Scalvini S. Feasibility and Clinical Efficacy of a Multidisciplinary Home-Telehealth Program to Prevent Falls in Older Adults: A Randomized Controlled Trial. J Am Med Dir Assoc. 2019 Mar;20(3):340-346. doi: 10.1016/j.jamda.2018.09.003. Epub 2018 Oct 23.
PubMed 30366759Toledano-Shubi A, Livne D, Hel-Or H, Bahat HS. Remote fall prevention training for community-dwelling older adults: comparison with face-to-face and effect of delivery sequence-A randomized controlled trial. Geriatr Nurs. 2026 Apr;69:103817. doi: 10.1016/j.gerinurse.2026.103817. Epub 2026 Jan 21.
PubMed 41570620
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Remote Fall Prevention Program vs. Face-to-Face in Low-medium Risk Elderly- A Cross Over Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05018455
- Acronym / sponsor ID
- Remote fall prevention
- Conditions
- Fall
- Keywords
- Telehealth, fall prevention, home dwelling elderly, Otago
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- Western Galilee Hospital-Nahariya
- Study start
- 28 Nov 2021 (actual)
- Primary completion
- 26 Mar 2023 (actual)
- Study completion
- 26 Mar 2023 (actual)
- First posted
- 24 Aug 2021 (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 are a serious problem in the elderly leading to injuries, morbidity, and consequently a heavy impact on the individual suffering, and society at large.
This study aims to investigate the effectiveness of a remote fall prevention program in comparison with a similar face-to-face program. This study design is a randomized control trial (RCT) with a cross-over in group allocation. The population will include 106 home-dwelling elderly, aged 65 years or more, with low to moderate risk of fall. Participants will be randomized to start intervention in the remote or face-to-face group. Training will be twice weekly for 3 months, after which there will be two weeks of washout, followed by a cross-over between groups. Outcome measures will include fall rate over a year (primary measure), balance, functional testing, subjective measures of fear of falls, quality of life, satisfaction from intervention, adherence, and compliance.
Detailed description
The aim of the proposed study is to investigate the effectiveness of a remote fall prevention training program. The proposed intervention program includes an Otago-based fall prevention training program to improve lower extremity strength, balance, and walking, directed by physical therapists, over 6 months. The remote group will train at home, using video communication software, while the face-to-face group will train at a local community center.
The proposed study will be designed as a randomized control trial (RCT) with a cross-over design. The population will include 106 home-dwelling elderly, aged 65 years or more, walking independently, that will be identified at low to moderate risk of fall. Candidates with unbalanced systemic disease or disorders, cognitive and physical Impairments that will prevent participation in the program, will not be included. A full description of the inclusion and exclusion criteria is provided below in the Eligibility section.
Participants will be randomized into two groups that will receive similar Otago-based fall prevention group training, either remotely or face-to-face.
The training sessions: The training starts with five minutes of gentle warm-up with the same five flexibility exercises, followed by structured lower limb muscles strengthening, balance exercises, and instruction for independent walking for up to 30 minutes at least twice a week. The training will be delivered to groups of ten participants. The duration of each session will be one hour, twice a week for three months. After three months of training, there will be a two weeks break, serving as a washout period, after which the groups will switch, for another three months. At the end of the intervention period (6.5 months), each participant will be trained by both remote and face-to-face programs. Assessments will be conducted at 4-time points: baseline, 3 months after completion of the first-ordered training, 6.5 months after completion of both trainings, and 12 months follow up.
The primary outcome measure is the number of falls during a year. secondary outcome measures include Objective measures as balance, Walking speed, lower extremities functional strength, adherence, and compliance to the training program. The subjective outcome measure will include participant Satisfaction from the program, Fear of falls, and Quality of life. More details regarding outcome measures are provided below in the outcome measure section.
Statistical analysis: The equivalence test will be used to examine if the remote fall prevention training is as good as the face-to-face. In order to check if there is a period-treatment effect on the objective outcome measures we will employ a mixed-model repeated-measures analysis of variance (ANOVA): 4-time points (baseline, 3 months, 6 months, 12 months follow up) X 2 interventions (remote vs. face-to-face), counting for the fact that subjects are nested in sequence. When interaction will be significant simple mean analysis will be used to reveal a significant source. Studentized Maximum Modulus (SMM) post-hoc adjustment method will be used to reveal significance between pairs of periods.
If this study will manage to show remote fall prevention is feasible, safe, and effective, it will promote a solution in one of the most serious health problems in the elderly, in one of the most challenging eras for the elderly, when remote healthcare is vital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention program will include Otago- based fall prevention training face-to-face or remote. Each subject will receive the two types of interventions in sequence, with a cooling-off period between them. The intervention program in this study will last 6 months, however, the intervention arm will be swapped after 3 months.
| Arm | Type | Receives |
|---|---|---|
| Fall prevention intervention program conducted through telehealth | Experimental | Other: Fall prevention program training based on Otago principlesThe training program is based on the principles of the Otago program, designed specifically to prevent falls. It consists set of leg muscle strengthening and balance retraining exercises progressing in difficulty, and a walking plan. The training will be delivered to a group of 10 participants. Each participant will practice from home, using a zoom system. The duration of each training will be one hour, the frequency of training will be twice a week for three months. |
| Similar fall prevention intervention program conducted through face to face group training | Active comparator | Other: Fall prevention program training based on Otago principlesThe training program is based on the principles of the Otago program, designed specifically to prevent falls. It consists set of leg muscle strengthening and balance retraining exercises progressing in difficulty, and a walking plan. The training will be delivered to a group of 10 participants. The training sessions will be delivered at the local community center, twice a week for one hour for three months. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- home-dwelling elderly, aged 65 years or more
- Identified to be at low to moderate risk of falling
- Risk of falling will be assessed according to a combination of subjective and objective evaluation. Subjective questions from the STEADI (stopping elderly accidents death, and injuries), an algorithm for fall risk screening, assessment, and intervention, developed by the American Center for Disease Control and Prevention, relate to (1) Feels unsteady when standing/walking, (2) Worries about falling, and (3) Has fallen no more than 3 times in the past year.
- An additional inclusion criterion is scoring 21 or more in the Mini-Best test (a balance test).
Key exclusion criteria (9 listed)
- Subjects suffering from severe musculoskeletal pain or disorders that will limit completion of the assessment procedure such as pain limiting weight-bearing for no longer than a few minutes
- Unstable cardiovascular/pulmonary disease
- Unbalanced diabetes
- Neurological diseases such as stroke, Parkinson's, or multiple sclerosis
- Use of a walking aid (except for a cane)
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 |
|---|---|---|
| Fall prevention program training based on Otago principlesbalance and strength exercises | Other | Fall prevention intervention program conducted through telehealth, Similar fall prevention intervention program conducted through face to face group training |
Primary outcome
Number of falls during the study period
Time frame: Falls will be monitored for one year
Subjects will self-report falls weekly in a personal fall diary. This will be supported by a telephone call from one of the investigators once a month.
11 secondary outcomes
Mini Balance Evaluation Systems Tests
Time frame: Change from baseline at 3, 6 and 12 months
Time-Up and Go Test
Time frame: Change from baseline at 3, 6 and 12 months
Berg Balance Scale
Time frame: Change from baseline at 3, 6 and 12 months
Four Stage Balance Test
Time frame: Change from baseline at 3, 6 and 12 months
Walking speed
Time frame: Change from baseline at 3, 6 and 12 months
Lower extremities functional strength
Time frame: Change from baseline at 3, 6 and 12 months
Attendance
Time frame: Will be monitored and record in any session time, for 6 months
Completion (retention)
Time frame: Will be monitored and record in any session time, for 6 months
Satisfaction from program
Time frame: Twice- after each program session (after 3 and 6 months).
Fear of falls
Time frame: Change from baseline at 3, 6 and 12 months
12-Item Short Form Survey (SF-12) Quality of life questionnaire
Time frame: Change from baseline at 3, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Background: PubMed 30703272Sherrington C, Fairhall NJ, Wallbank GK, Tiedemann A, Michaleff ZA, Howard K, Clemson L, Hopewell S, Lamb SE. Exercise for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2019 Jan 31;1(1):CD012424. doi: 10.1002/14651858.CD012424.pub2.
- Background: PubMed 24339273Kyrdalen IL, Moen K, Roysland AS, Helbostad JL. The Otago Exercise Program performed as group training versus home training in fall-prone older people: a randomized controlled Trial. Physiother Res Int. 2014 Jun;19(2):108-16. doi: 10.1002/pri.1571. Epub 2013 Dec 11.
- Background: PubMed 30366759Bernocchi P, Giordano A, Pintavalle G, Galli T, Ballini Spoglia E, Baratti D, Scalvini S. Feasibility and Clinical Efficacy of a Multidisciplinary Home-Telehealth Program to Prevent Falls in Older Adults: A Randomized Controlled Trial. J Am Med Dir Assoc. 2019 Mar;20(3):340-346. doi: 10.1016/j.jamda.2018.09.003. Epub 2018 Oct 23.
- Derived from this study: PubMed 41570620Toledano-Shubi A, Livne D, Hel-Or H, Bahat HS. Remote fall prevention training for community-dwelling older adults: comparison with face-to-face and effect of delivery sequence-A randomized controlled trial. Geriatr Nurs. 2026 Apr;69:103817. doi: 10.1016/j.gerinurse.2026.103817. Epub 2026 Jan 21.
- Otago Exercise Programme to prevent falls in older adultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Hilla Sarig Bahat, PT PhD principal investigator
Department of Physical Therapy, University of Haifa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fall prevention program training based on Otago principles in people with Fall, run by University of Haifa at 2 sites in Israel.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of falls during the study period (time frame: Falls will be monitored for one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05018455, which also lists 4 linked publications.
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 13 Nov 2023.