Peripheral Neuropathy Due to ChemotherapyNCT06313359
Fall Risk and Quality of Life: in Individuals With Cancer Treatment Related Peripheral Neuropathy.
An observational study of Peripheral Neuropathy Due to Chemotherapy, run by Texas Woman's University at 1 site in United States.
Trial summary
The purpose of this research is to examine the impact of peripheral neuropathy on fall risk and quality of life in people who had cancer and neuropathy from cancer treatments. The investigators are interested to find out if the participant have any difficulty with thinking, feeling, balancing, or moving around that… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Neuropathy Due to Chemotherapy
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2025to 16 Oct 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Non CNS Cancer population with neuropathy symptoms related to cancer treatments.
Who may be able to join
- Experimental group
- Individuals 18 years and older
- diagnosed with non- CNS cancer who underwent treatment and presents with peripheral neuropathy symptoms.
- Control group
- age (+/- one year) and gender matched individuals
- no diagnosed peripheral neuropathy
- No diagnosed cognitive symptoms.
Who cannot join
- Unable to follow two step commands.
- Unable to ambulate x 50 feet independently without use of an assistive device.
- Unable to use a phone to send text messages.
- Diagnosis of diabetic peripheral neuropathy
- Diagnosis of CNS cancer.
- Unable to speak/understand English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fall Risk and Quality of Life: Influence of Dual Task Performance, Cognition, and Sensorimotor Variables in Individuals With Cancer Treatment Related Peripheral Neuropathy.
The purpose of this research is to examine the impact of peripheral neuropathy on fall risk and quality of life in people who had cancer and neuropathy from cancer treatments. The investigators are interested to find out if the participant have any difficulty with thinking, feeling, balancing, or moving around that will contribute to risk for falls or quality of life. Investigators are also interested to see if the participants have any difficulty with doing two activities at the same time, such as walking and texting.
Read the detailed description
Cancer related cognitive impairment (CRCI) is a common side effect of treatment of cancer during and after chemotherapy and is seen in patients with non-central nervous system( non-CNS) cancer. Though common after chemotherapy, other treatments such as hormone therapies and targeted therapies can also cause cognitive deficits.. The self-reported prevalence of cognitive complains in cancer survivors was 75% in a large web based study with non CNS cancers . The clinical presentation of these cognitive impairments include memory deficits, difficulty with learning attention, concentration, reasoning, processing speed, executive functions and visuospatial skills. Therefore the cognitive impairment can have a negative impact on quality of life, daily functioning and ability to work in patients with cancer while undergoing treatment and while in remission.
Acquired Peripheral Neuropathy (APN) is another common side effect of treatment for cancer. While majority of the peripheral neuropathy symptoms are due to neurotoxic chemotherapy agents resulting in chemotherapy-induced peripheral neuropathy (CIPN), neuropathy symptoms can also occur as paraneoplastic, immune-mediated, or neoplastic neuropathies. The reported prevalence of CIPN is 68% within first month after chemotherapy and continued to be present in 47% of the survivors even 6 years later. The clinical presentation of the CIPN includes numbness, tingling, or burning, neuropathic pain, decrease of muscle tone and coordination, and loss of balance. The symptoms tends to begin distally in the fingers and toes and moves proximally through the extremities. CIPN is typically associated with treatment using platinum based drugs, taxanes, epothilones, vinca alkaloids, bortezomib and thalidomide.
Individuals with CIPN are significantly more likely to suffer falls and fall related injuries. In breast cancer survivors with neuropathy, 40.9% experienced falls on both flat surfaces and non-flat surfaces during upright activities. Gait is a complex functional activity that requires the integration of the musculoskeletal, sensory, neurological, and cognitive systems. Significant gait variability in step width and step length with forward walking has been reported in cancer survivors with peripheral neuropathy compared to healthy controls. However, normal daily walking does not include just walking in a forward direction, but rather it involves walking in different directions such as walking backwards to sit in a chair. Although gait variability has been reported with forward walking, the gait variability while walking backwards in patients with cancer with APN has not been investigated previously.
Cognitive impairment has been strongly associated with decreased performance in dual task abilities and higher number of falls in older adults. Performing concurrent tasks such as walking and talking or walking and texting is a normal aspect of life. Concurrent performance of two tasks with distinct motor and cognitive demands has been associated with increased fall risk in older adults. Ability to do such dual task (DT) has shown to be declined in persons with cognitive and motor impairments. Ability to perform DT has been also reported to be affected in persons with diabetic peripheral neuropathy. There is only one reported study that evaluated the cognitive and sensory deficits associated with orbital stability in gait on treadmill during single and dual task in cancer survivors with and without peripheral neuropathy. However, walking on the treadmill at fixed speed does not translate to the real-world adaptations on overground walking in different directions with the added challenge of a cognitive task. Though cognitive and peripheral neuropathy symptoms are reported in patients with non- CNS cancers who are undergoing treatment and while in remission, ability to perform dual task with forward and backward walking has not been assessed in this population and not compared with an age and gender matched control without peripheral neuropathy. Additionally, it is important to investigate what cognitive, motor and sensory impairments can predict fall risk and decreased quality of life in this population compared to an age and gender matched control.
The purpose of this proposed exploratory pilot study is to evaluate the dual task cost of variable walking in individuals diagnosed with cancer treatment induced peripheral neuropathy compared to age and gender matched individuals without peripheral neuropathy. backward walking on an over ground computerized mat. A secondary purpose will be to identify what type of cognitive, motor and sensory impairments can correlate quality of life in individuals diagnosed with cancer treatment induced peripheral neuropathy and can predict fall risk in this population compared to compared to age and gender.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cancer treatment induced peripheral neuropathy | Individuals with a history of non CNS cancer with cancer treatment induced peripheral neuropathy symptoms. | |
| Control group | Age and gender matched individuals without peripheral neuropathy symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall risk
Fall risk will be assessed using the Timed Up and Go (TUG)-Test. For the TUG, the participant will be asked to stand up from a chair, walk 3 m and touch a line on the floor, walk back to the chair and sit down. Timing of the test will begin when the tester gives the command "go" and will be stopped when the participant made contact with the chair as they sat down.
Measured: 5 minutes
Quality of life- in cancer patients
Participants in the cancer related peripheral neuropathy group will complete the Functional Assessment of Cancer Therapy- General (FACT-G ) to assess self-reported quality of life. The FACT-G uses a 5-point Likert scale, with higher numbers indicating a better health state.
Measured: 5 minutes
Secondary outcomes (10)
Trail Making Test (TMT) Parts A & B
Trail Making Test assesses attention, psychomotor, and higher-level cognitive function and has been recommended to be used to in cancer population. The time it takes to complete the parts A and B will be recorded in seconds
Measured: 5 minutes
Single Task- Working Memory
Single task assessment of working memory will be assessed by randomly picking one of the following tests (serial sevens (7s), spelling words backwards or recite months backwards) for 30 seconds in seated position.
Measured: 3 minutes
Single Task- Visual Attention Cognitive Task
Visual-attention cognitive tasks will be tested by randomly selecting one of the following texting activity for 30 seconds (texting animal names, cities, or colors on a smart phone) in a seated position.
Measured: 3 minutes
Protective Sensation
Protective sensation in the upper and lower extremities will be measured using the Semmes-Weinstein monofilament.
Measured: 5 minutes
Grip Strength
Grip strength will be assessed using a Jamar handheld dynamometer.
Measured: 5 minutes
LE strength assessment- HHD
Muscle strength testing of the ankle dorsiflexors, knee flexors, knee extensors, hip flexors, hip extensors and hip abductors using a handheld dynamometer using a make test.
Measured: 10 minutes
Dynamic Balance
Dynamic balance and coordination will be assessed using the Four-Square Step Test (FSST).
Measured: 5 minutes
Single Task- Gait Speed
For the single task gait component, we will utilize the Zeno© Electronic Walkway for assessing walking in both forward and backward directions using self-selected speed. Participants will commence/continue walking two feet prior to and after contacting the electronic walkway to account for acceleration and deceleration.
Measured: 8 minutes
Dual Task- Working Memory & Gait Speed - Composite measure
Participants will complete three trials of walking forward and three trials of walking backward with simultaneous execution of a randomly selected working memory task (serial sevens (7s), spelling words backwards or recite months backwards)
Measured: 5 minutes
Dual Task- Visual Attention Cognitive Task & Gait Speed - Composite measure
Participants will complete three trials of walking forward and three trials of walking backward with simultaneous execution of a randomly selected visual-attention cognitive task (texting animal names, cities, or colors on a smart phone)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start16 Oct 2025
- Primary completion16 Oct 2025
- Study completion16 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Peripheral Neuropathy Due to ChemotherapyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priya Karakkattil, Texas Woman's University
- Investigators
- Priya Karakkattil, PhD, Principal investigator, Texas Woman's UniversityAsha Vas, PhD, Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313359
- Sponsor's protocol ID
- FY2024-125
- Status last verified
- Oct 2024
- First submitted
- 1 Mar 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lange M, Joly F, Vardy J, Ahles T, Dubois M, Tron L, Winocur G, De Ruiter MB, Castel H. Cancer-related cognitive impairment: an update on state of the art, detection, and management strategies in cancer survivors. Ann Oncol. 2019 Dec 1;30(12):1925-1940. doi: 10.1093/annonc/mdz410.
PubMed 31617564Staff NP, Grisold A, Grisold W, Windebank AJ. Chemotherapy-induced peripheral neuropathy: A current review. Ann Neurol. 2017 Jun;81(6):772-781. doi: 10.1002/ana.24951. Epub 2017 Jun 5.
PubMed 28486769Small GH, Brough LG, Neptune RR. The influence of cognitive load on balance control during steady-state walking. J Biomech. 2021 Jun 9;122:110466. doi: 10.1016/j.jbiomech.2021.110466. Epub 2021 Apr 23.
PubMed 33962328Mounier NM, Abdel-Maged AE, Wahdan SA, Gad AM, Azab SS. Chemotherapy-induced cognitive impairment (CICI): An overview of etiology and pathogenesis. Life Sci. 2020 Oct 1;258:118071. doi: 10.1016/j.lfs.2020.118071. Epub 2020 Jul 14.
PubMed 32673664Montero-Odasso M, Sarquis-Adamson Y, Kamkar N, Pieruccini-Faria F, Bray N, Cullen S, Mahon J, Titus J, Camicioli R, Borrie MJ, Bherer L, Speechley M. Dual-task gait speed assessments with an electronic walkway and a stopwatch in older adults. A reliability study. Exp Gerontol. 2020 Dec;142:111102. doi: 10.1016/j.exger.2020.111102. Epub 2020 Oct 2.
PubMed 33017671Komatsu H, Yagasaki K, Komatsu Y, Yamauchi H, Yamauchi T, Shimokawa T, Doorenbos AZ. Falls and Functional Impairments in Breast Cancer Patients with Chemotherapy-Induced Peripheral Neuropathy. Asia Pac J Oncol Nurs. 2019 Jul-Sep;6(3):253-260. doi: 10.4103/apjon.apjon_7_19.
PubMed 31259221Autissier E. Chemotherapy-Induced Peripheral Neuropathy: Association With Increased Risk of Falls and Injuries. Clin J Oncol Nurs. 2019 Aug 1;23(4):405-410. doi: 10.1188/19.CJON.405-410.
PubMed 31322611
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fall Risk and Quality of Life: Influence of Dual Task Performance, Cognition, and Sensorimotor Variables in Individuals With Cancer Treatment Related Peripheral Neuropathy.
- ClinicalTrials.gov ID
- NCT06313359
- Acronym / sponsor ID
- FY2024-125
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 16 Oct 2025 (actual)
- First posted
- 15 Mar 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.
The purpose of this research is to examine the impact of peripheral neuropathy on fall risk and quality of life in people who had cancer and neuropathy from cancer treatments. The investigators are interested to find out if the participant have any difficulty with thinking, feeling, balancing, or moving around that will contribute to risk for falls or quality of life. Investigators are also interested to see if the participants have any difficulty with doing two activities at the same time, such as walking and texting.
Detailed description
Cancer related cognitive impairment (CRCI) is a common side effect of treatment of cancer during and after chemotherapy and is seen in patients with non-central nervous system( non-CNS) cancer. Though common after chemotherapy, other treatments such as hormone therapies and targeted therapies can also cause cognitive deficits.. The self-reported prevalence of cognitive complains in cancer survivors was 75% in a large web based study with non CNS cancers . The clinical presentation of these cognitive impairments include memory deficits, difficulty with learning attention, concentration, reasoning, processing speed, executive functions and visuospatial skills. Therefore the cognitive impairment can have a negative impact on quality of life, daily functioning and ability to work in patients with cancer while undergoing treatment and while in remission.
Acquired Peripheral Neuropathy (APN) is another common side effect of treatment for cancer. While majority of the peripheral neuropathy symptoms are due to neurotoxic chemotherapy agents resulting in chemotherapy-induced peripheral neuropathy (CIPN), neuropathy symptoms can also occur as paraneoplastic, immune-mediated, or neoplastic neuropathies. The reported prevalence of CIPN is 68% within first month after chemotherapy and continued to be present in 47% of the survivors even 6 years later. The clinical presentation of the CIPN includes numbness, tingling, or burning, neuropathic pain, decrease of muscle tone and coordination, and loss of balance. The symptoms tends to begin distally in the fingers and toes and moves proximally through the extremities. CIPN is typically associated with treatment using platinum based drugs, taxanes, epothilones, vinca alkaloids, bortezomib and thalidomide.
Individuals with CIPN are significantly more likely to suffer falls and fall related injuries. In breast cancer survivors with neuropathy, 40.9% experienced falls on both flat surfaces and non-flat surfaces during upright activities. Gait is a complex functional activity that requires the integration of the musculoskeletal, sensory, neurological, and cognitive systems. Significant gait variability in step width and step length with forward walking has been reported in cancer survivors with peripheral neuropathy compared to healthy controls. However, normal daily walking does not include just walking in a forward direction, but rather it involves walking in different directions such as walking backwards to sit in a chair. Although gait variability has been reported with forward walking, the gait variability while walking backwards in patients with cancer with APN has not been investigated previously.
Cognitive impairment has been strongly associated with decreased performance in dual task abilities and higher number of falls in older adults. Performing concurrent tasks such as walking and talking or walking and texting is a normal aspect of life. Concurrent performance of two tasks with distinct motor and cognitive demands has been associated with increased fall risk in older adults. Ability to do such dual task (DT) has shown to be declined in persons with cognitive and motor impairments. Ability to perform DT has been also reported to be affected in persons with diabetic peripheral neuropathy. There is only one reported study that evaluated the cognitive and sensory deficits associated with orbital stability in gait on treadmill during single and dual task in cancer survivors with and without peripheral neuropathy. However, walking on the treadmill at fixed speed does not translate to the real-world adaptations on overground walking in different directions with the added challenge of a cognitive task. Though cognitive and peripheral neuropathy symptoms are reported in patients with non- CNS cancers who are undergoing treatment and while in remission, ability to perform dual task with forward and backward walking has not been assessed in this population and not compared with an age and gender matched control without peripheral neuropathy. Additionally, it is important to investigate what cognitive, motor and sensory impairments can predict fall risk and decreased quality of life in this population compared to an age and gender matched control.
The purpose of this proposed exploratory pilot study is to evaluate the dual task cost of variable walking in individuals diagnosed with cancer treatment induced peripheral neuropathy compared to age and gender matched individuals without peripheral neuropathy. backward walking on an over ground computerized mat. A secondary purpose will be to identify what type of cognitive, motor and sensory impairments can correlate quality of life in individuals diagnosed with cancer treatment induced peripheral neuropathy and can predict fall risk in this population compared to compared to age and gender.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer treatment induced peripheral neuropathy | – | –Individuals with a history of non CNS cancer with cancer treatment induced peripheral neuropathy symptoms. |
| Control group | – | –Age and gender matched individuals without peripheral neuropathy symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Non CNS Cancer population with neuropathy symptoms related to cancer treatments.
Key inclusion criteria (7 listed)
- Experimental group
- Individuals 18 years and older
- diagnosed with non- CNS cancer who underwent treatment and presents with peripheral neuropathy symptoms.
- Control group
- age (+/- one year) and gender matched individuals
Key exclusion criteria (6 listed)
- Unable to follow two step commands.
- Unable to ambulate x 50 feet independently without use of an assistive device.
- Unable to use a phone to send text messages.
- Diagnosis of diabetic peripheral neuropathy
- Diagnosis of CNS cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fall risk
Time frame: 5 minutes
Fall risk will be assessed using the Timed Up and Go (TUG)-Test. For the TUG, the participant will be asked to stand up from a chair, walk 3 m and touch a line on the floor, walk back to the chair and sit down. Timing of the test will begin when the tester gives the command "go" and will be stopped when the participant made contact with the chair as they sat down.
Quality of life- in cancer patients
Time frame: 5 minutes
Participants in the cancer related peripheral neuropathy group will complete the Functional Assessment of Cancer Therapy- General (FACT-G ) to assess self-reported quality of life. The FACT-G uses a 5-point Likert scale, with higher numbers indicating a better health state.
10 secondary outcomes
Trail Making Test (TMT) Parts A & B
Time frame: 5 minutes
Single Task- Working Memory
Time frame: 3 minutes
Single Task- Visual Attention Cognitive Task
Time frame: 3 minutes
Protective Sensation
Time frame: 5 minutes
Grip Strength
Time frame: 5 minutes
LE strength assessment- HHD
Time frame: 10 minutes
Dynamic Balance
Time frame: 5 minutes
Single Task- Gait Speed
Time frame: 8 minutes
Dual Task- Working Memory & Gait Speed - Composite measure
Time frame: 5 minutes
Dual Task- Visual Attention Cognitive Task & Gait Speed - Composite measure
Time frame: 5 minutes
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 2 Oct 2026.
- Background: PubMed 31617564Lange M, Joly F, Vardy J, Ahles T, Dubois M, Tron L, Winocur G, De Ruiter MB, Castel H. Cancer-related cognitive impairment: an update on state of the art, detection, and management strategies in cancer survivors. Ann Oncol. 2019 Dec 1;30(12):1925-1940. doi: 10.1093/annonc/mdz410.
- Results publication: PubMed 28486769Staff NP, Grisold A, Grisold W, Windebank AJ. Chemotherapy-induced peripheral neuropathy: A current review. Ann Neurol. 2017 Jun;81(6):772-781. doi: 10.1002/ana.24951. Epub 2017 Jun 5.
- Results publication: PubMed 33962328Small GH, Brough LG, Neptune RR. The influence of cognitive load on balance control during steady-state walking. J Biomech. 2021 Jun 9;122:110466. doi: 10.1016/j.jbiomech.2021.110466. Epub 2021 Apr 23.
- Results publication: PubMed 32673664Mounier NM, Abdel-Maged AE, Wahdan SA, Gad AM, Azab SS. Chemotherapy-induced cognitive impairment (CICI): An overview of etiology and pathogenesis. Life Sci. 2020 Oct 1;258:118071. doi: 10.1016/j.lfs.2020.118071. Epub 2020 Jul 14.
- Results publication: PubMed 33017671Montero-Odasso M, Sarquis-Adamson Y, Kamkar N, Pieruccini-Faria F, Bray N, Cullen S, Mahon J, Titus J, Camicioli R, Borrie MJ, Bherer L, Speechley M. Dual-task gait speed assessments with an electronic walkway and a stopwatch in older adults. A reliability study. Exp Gerontol. 2020 Dec;142:111102. doi: 10.1016/j.exger.2020.111102. Epub 2020 Oct 2.
- Results publication: PubMed 31259221Komatsu H, Yagasaki K, Komatsu Y, Yamauchi H, Yamauchi T, Shimokawa T, Doorenbos AZ. Falls and Functional Impairments in Breast Cancer Patients with Chemotherapy-Induced Peripheral Neuropathy. Asia Pac J Oncol Nurs. 2019 Jul-Sep;6(3):253-260. doi: 10.4103/apjon.apjon_7_19.
- Results publication: PubMed 31322611Autissier E. Chemotherapy-Induced Peripheral Neuropathy: Association With Increased Risk of Falls and Injuries. Clin J Oncol Nurs. 2019 Aug 1;23(4):405-410. doi: 10.1188/19.CJON.405-410.
- Individual participant dataSharing planned: Undecided
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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.
Priya Karakkattil, PhD principal investigator
Texas Woman's University
Asha Vas, PhD principal investigator
Texas Woman's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Neuropathy Due to Chemotherapy, run by Texas Woman's University at 1 site in United States.
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 7 inclusion and 6 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 2 Oct 2026. 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 United States. 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?
Fall risk (time frame: 5 minutes). The study lists 2 primary outcomes in all. 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 NCT06313359, which also lists 7 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 2 Oct 2026.