Physical ActivityNCT06939881
"11 For Health" in Türkiye; Effect on Physical Performance and Executive Function in 10-11-Year-Olds
A study testing "11 for Health" training group in people with Physical Activity and Executive Function (Cognition), run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this study was to evaluate whether the school-based "11 for Health" program could improve physical performance and executive function among 10-11-year-old Turkish schoolchildren. Read more about this study
- Who is it for?
- Ages 10 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Executive Function (Cognition), Physical Performance
- What is being tested?
- "11 for Health" training group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2024to 14 Jun 2024
- 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 10 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Typically developing children
- Aged between 10 and 11 years
- Enrolled in the 5th grade of primary school
- Not currently taking any medication
- Provided informed consent from both the child and their parent/guardian
Who cannot join
- Having any diagnosed cardiovascular, neurological, orthopedic, or psychiatric condition
- Taking regular medication
- Outside the age range of 10-11 years
- Presence of any developmental disorder or learning disability
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tekirdag Namik Kemal University, Sports Sciences Research and Development Centre, Tekirdag, Suleymanpasa 59030
Tekirdağ, Suleymanpasa, 59030
About this study
Official title: "11 For Health" in Türkiye - Effects on Physical Performance and Executive Function in 10-11-Years-Old Schoolchildren
The goal of this study was to evaluate whether the school-based "11 for Health" program could improve physical performance and executive function among 10-11-year-old Turkish schoolchildren. The main questions it aimed to answer were:
Does the program enhance physical performance, including agility, balance, and vertical jump? Does it improve executive function skills such as response inhibition, problem solving, and working memory? Researchers compared students who participated in the 11-week "11 for Health" intervention to those who continued their regular school curriculum.
Read more
Participants:
A total of 56 children (28 girls and 28 boys) from 5th grade participated. The training group attended two 45-minute "11 for Health" sessions per week for 11 weeks.
Both groups were assessed before and after the intervention on physical performance (e.g., balance, agility, countermovement jump) and executive function (Go/No-Go, Tower of Hanoi, and Corsi Block tests).
Read the detailed description
This study examined the impact of the school-based "11 for Health" program on the physical performance and executive function of 10-11-year-old Turkish schoolchildren. The program, developed by FIFA in collaboration with global health experts, integrates football-based physical activities with health education content. Given the growing concern over insufficient physical activity levels among children in Türkiye, the intervention sought to explore how structured school-based programs could enhance not only physical performance but also higher-order cognitive processes.
The rationale for the study stems from evidence indicating that physical activity is not only essential for maintaining cardiovascular and musculoskeletal health but also closely linked to cognitive functions such as attention, response inhibition, and planning. Executive functions are critical during late childhood as they influence academic performance, behavior regulation, and social competence.
The "11 for Health" intervention consisted of two 45-minute sessions per week for 11 weeks, implemented during school hours. Each week included one session focused on football-related physical activities (e.g., passing, dribbling, shooting) and another on health education topics (e.g., hygiene, nutrition, mental well-being), both delivered in an engaging and inclusive format. The program emphasized social interaction, autonomy-supportive teaching, and real-life applicability through take-home tasks.
Participants were divided into a training group and a control group using convenience sampling. The training group received the intervention, while the control group continued their standard physical education curriculum. Pre- and post-intervention assessments were conducted over separate days to measure changes in physical and cognitive outcomes.
Physical performance was assessed using standardized protocols to evaluate balance (static, proprioceptive, dynamic), agility (pro-agility shuttle test), and vertical jump (countermovement jump). Executive function was measured using three computer-based tasks: the Go/No-Go test (response inhibition), the Tower of Hanoi (planning/problem-solving), and the Corsi Block Test (visuospatial working memory).
The study contributes to the growing literature on school-based physical activity interventions and their multifaceted impact on children's development, offering insights relevant to both educators and policymakers seeking to optimize school curricula for health and cognitive outcomes.
- Being tested
- "11 for Health" training group
- Keywords
- 11 for Health in Türkiye, executive function, schoolchildren
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"11 for Health" training groupOther
The "11 for Health" intervention consisted of two 45-minute sessions per week for 11 weeks, implemented during school hours. Each week included one session focused on football-related physical activities (e.g., passing, dribbling, shooting) and another on health education topics (e.g., hygiene, nutrition, mental well-being), both delivered in an engaging and inclusive format. The program emphasized social interaction, autonomy-supportive teaching, and real-life applicability through take-home tasks.
| Study group | Role | What they receive |
|---|---|---|
| "11 for Health" program | Experimental | "11 for Health" program training group Receives: Other: "11 for Health" training group |
| control group | No intervention | Control Group; The control group continued with their regular school curriculum, which included two 45-minute physical education classes per week, and did not receive any additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Static Balance Performance (% Score)
Static balance was measured using the Sensbalance MiniBoard device. Participants were asked to stand still on the platform for approximately 30 seconds. The device calculated the participant's ability to maintain posture without significant sway.
Measured: before and at the end of the 11-week intervention.
Changes in Dynamic Balance Performance - Left-Right and Front-Back (% Score)
Dynamic balance was evaluated using the Sensbalance MiniBoard through controlled weight shifting in mediolateral and anteroposterior directions.
Measured: before and at the end of the 11-week intervention.
Changes in Proprioceptive Balance Performance (% Score)
Proprioceptive balance was assessed via subtle postural adjustments on the Sensbalance MiniBoard. Scores were automatically generated based on sway control.
Measured: before and at the end of the 11-week intervention.
Changes in Countermovement Jump Performance (cm)
Vertical jump height was measured using an accelerometer-based system (IVMES, Ankara, Turkey) during countermovement jump (CMJ) trials. Unit of Measurement: Centimeter (cm) - Highest jump height
Measured: before and at the end of the 11-week intervention.
Changes in Agility (seconds)
Assessed via the Pro-Agility Test (20-yard shuttle run) using photocell timing gates. The total time to complete the right-left-center shuttle sequence was recorded. Unit of Measurement: Seconds (s) - Time to complete the test
Measured: before and at the end of the 11-week intervention.
Changes in Inhibitory Control (Number of correct responses and Reaction Time (ms))
Inhibitory control was assessed using a computer-based Go/No-Go task, which measured participants' ability to suppress automatic motor responses. The task included 200 trials: 100 Go (letter X) and 100 No-Go (letter O) stimuli. Participants were instructed to press a button as quickly as possible for Go stimuli and withhold responses for No-Go stimuli. Key outcome variables included:
Accuracy of correct responses to Go stimuli (AC-Go) Accuracy of correct inhibitions to No-Go stimuli (AC-NoGo) Mean reaction time for correct Go responses (Go RT)
Unit of Measurement: Number of correct responses and reaction time in milliseconds (ms)
Measured: before and at the end of the 11-week intervention.
Changes in Planning and Problem-Solving Skills (Number of moves and seconds)
Description: Executive function was assessed using a computer-based Tower of Hanoi task, designed to evaluate planning, problem-solving, and rule-based learning. Participants moved three disks across three pegs while following predefined rules to match a target configuration. Four outcome variables were recorded:
Total number of moves Total time to solution (seconds) Average time per move (seconds) Latency to first move (planning time in seconds)
Unit of Measurement: Number of moves and seconds (s)
Measured: before and at the end of the 11-week intervention.
Changes in Visuospatial Working Memory (correctly repeated number score)
Description: The Corsi Block Test was used to evaluate visual working memory and attention. In this computerized task, participants were asked to reproduce increasingly complex sequences of illuminated blocks. The task terminated when the participant failed to correctly repeat sequences of a given length twice in a row.
Unit of Measurement: Span score (maximum sequence length correctly repeated)
Measured: before and at the end of the 11-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start5 Feb 2024
- Primary completion23 Feb 2024
- Study completion14 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study sample was determined and divided into groups using the convenience sampling method. This non-random sampling approach involves selecting participants based on the researcher's judgment, allowing for practical, fast, and cost-effective data collection. At this stage, two 5th-grade classes from the same school that met the inclusion criteria and agreed to participate were selected. One class was assigned as the control group (CG; n=29) and the other as the training group (TG; n=27).
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, umut canlı, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939881
- Sponsor's protocol ID
- NamikemalUU
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Measurements: Data obtained from physical fitness parameters (e.g., static, dynamic and proprioceptive balance, agility, countermovement jump) and executive function assessments (e.g., Go/No-Go, Tower of Hanoi, and Corsi Block tests) will be shared. Data Anonymization: All shared data will be fully anonymized to ensure participant confidentiality. Personal identifiers such as names, birth dates, and school affiliations will be removed. Data will be reviewed and aggregated where necessary to prevent the possibility of participant re-identification. Data Format: The data will be provided in standardized file formats such as CSV or Excel (.xlsx) to support compatibility and ease of use in secondary analyses. Access Control: Access to the shared IPD will be granted to qualified researchers who provide a valid research proposal and agree to comply with data use agreements that ensure the data will be used solely for research purposes and not for commercial gain.
Publications
Lind RR, Geertsen SS, Orntoft C, Madsen M, Larsen MN, Dvorak J, Ritz C, Krustrup P. Improved cognitive performance in preadolescent Danish children after the school-based physical activity programme "FIFA 11 for Health" for Europe - A cluster-randomised controlled trial. Eur J Sport Sci. 2018 Feb;18(1):130-139. doi: 10.1080/17461391.2017.1394369. Epub 2017 Nov 21.
PubMed 29161988Madsen M, Elbe AM, Madsen EE, Ermidis G, Ryom K, Wikman JM, Rasmussen Lind R, Larsen MN, Krustrup P. The "11 for Health in Denmark" intervention in 10- to 12-year-old Danish girls and boys and its effects on well-being-A large-scale cluster RCT. Scand J Med Sci Sports. 2020 Sep;30(9):1787-1795. doi: 10.1111/sms.13704. Epub 2020 May 27.
PubMed 32353906Sendil AM, Canli U, Larsen MN, Tarantino G, Krustrup P, Aldhahi MI. Effects of the 11 for Health program on physical performance and executive functions in schoolchildren. Sci Rep. 2026 Feb 12;16(1):8439. doi: 10.1038/s41598-026-38837-5.
PubMed 41673200
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "11 For Health" in Türkiye - Effects on Physical Performance and Executive Function in 10-11-Years-Old Schoolchildren
- ClinicalTrials.gov ID
- NCT06939881
- Acronym / sponsor ID
- NamikemalUU
- Keywords
- 11 for Health in Türkiye, executive function, schoolchildren
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 23 Apr 2025 (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 goal of this study was to evaluate whether the school-based "11 for Health" program could improve physical performance and executive function among 10-11-year-old Turkish schoolchildren. The main questions it aimed to answer were:
Does the program enhance physical performance, including agility, balance, and vertical jump? Does it improve executive function skills such as response inhibition, problem solving, and working memory? Researchers compared students who participated in the 11-week "11 for Health" intervention to those who continued their regular school curriculum.
Participants:
A total of 56 children (28 girls and 28 boys) from 5th grade participated. The training group attended two 45-minute "11 for Health" sessions per week for 11 weeks.
Both groups were assessed before and after the intervention on physical performance (e.g., balance, agility, countermovement jump) and executive function (Go/No-Go, Tower of Hanoi, and Corsi Block tests).
Detailed description
This study examined the impact of the school-based "11 for Health" program on the physical performance and executive function of 10-11-year-old Turkish schoolchildren. The program, developed by FIFA in collaboration with global health experts, integrates football-based physical activities with health education content. Given the growing concern over insufficient physical activity levels among children in Türkiye, the intervention sought to explore how structured school-based programs could enhance not only physical performance but also higher-order cognitive processes.
The rationale for the study stems from evidence indicating that physical activity is not only essential for maintaining cardiovascular and musculoskeletal health but also closely linked to cognitive functions such as attention, response inhibition, and planning. Executive functions are critical during late childhood as they influence academic performance, behavior regulation, and social competence.
The "11 for Health" intervention consisted of two 45-minute sessions per week for 11 weeks, implemented during school hours. Each week included one session focused on football-related physical activities (e.g., passing, dribbling, shooting) and another on health education topics (e.g., hygiene, nutrition, mental well-being), both delivered in an engaging and inclusive format. The program emphasized social interaction, autonomy-supportive teaching, and real-life applicability through take-home tasks.
Participants were divided into a training group and a control group using convenience sampling. The training group received the intervention, while the control group continued their standard physical education curriculum. Pre- and post-intervention assessments were conducted over separate days to measure changes in physical and cognitive outcomes.
Physical performance was assessed using standardized protocols to evaluate balance (static, proprioceptive, dynamic), agility (pro-agility shuttle test), and vertical jump (countermovement jump). Executive function was measured using three computer-based tasks: the Go/No-Go test (response inhibition), the Tower of Hanoi (planning/problem-solving), and the Corsi Block Test (visuospatial working memory).
The study contributes to the growing literature on school-based physical activity interventions and their multifaceted impact on children's development, offering insights relevant to both educators and policymakers seeking to optimize school curricula for health and cognitive outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study sample was determined and divided into groups using the convenience sampling method. This non-random sampling approach involves selecting participants based on the researcher's judgment, allowing for practical, fast, and cost-effective data collection. At this stage, two 5th-grade classes from the same school that met the inclusion criteria and agreed to participate were selected. One class was assigned as the control group (CG; n=29) and the other as the training group (TG; n=27).
| Arm | Type | Receives |
|---|---|---|
| "11 for Health" program | Experimental | Other: "11 for Health" training group"11 for Health" program training group |
| control group | No intervention | –Control Group; The control group continued with their regular school curriculum, which included two 45-minute physical education classes per week, and did not receive any additional intervention. |
Who may qualify
- Ages
- 10 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Typically developing children
- Aged between 10 and 11 years
- Enrolled in the 5th grade of primary school
- Not currently taking any medication
- Provided informed consent from both the child and their parent/guardian
Key exclusion criteria (4 listed)
- Having any diagnosed cardiovascular, neurological, orthopedic, or psychiatric condition
- Taking regular medication
- Outside the age range of 10-11 years
- Presence of any developmental disorder or learning disability
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 |
|---|---|---|
| "11 for Health" training groupThe "11 for Health" intervention consisted of two 45-minute sessions per week for 11 weeks, implemented during school hours. Each week included one session focused on football-related physical activities (e.g., passing, dribbling, shooting) and another on health education topics (e.g., hygiene, nutrition, mental well-being), both delivered in an engaging and inclusive format. The program emphasized social interaction, autonomy-supportive teaching, and real-life applicability through take-home tasks. | Other | "11 for Health" program |
Primary outcome
Changes in Static Balance Performance (% Score)
Time frame: before and at the end of the 11-week intervention.
Static balance was measured using the Sensbalance MiniBoard device. Participants were asked to stand still on the platform for approximately 30 seconds. The device calculated the participant's ability to maintain posture without significant sway.
Changes in Dynamic Balance Performance - Left-Right and Front-Back (% Score)
Time frame: before and at the end of the 11-week intervention.
Dynamic balance was evaluated using the Sensbalance MiniBoard through controlled weight shifting in mediolateral and anteroposterior directions.
Changes in Proprioceptive Balance Performance (% Score)
Time frame: before and at the end of the 11-week intervention.
Proprioceptive balance was assessed via subtle postural adjustments on the Sensbalance MiniBoard. Scores were automatically generated based on sway control.
Changes in Countermovement Jump Performance (cm)
Time frame: before and at the end of the 11-week intervention.
Vertical jump height was measured using an accelerometer-based system (IVMES, Ankara, Turkey) during countermovement jump (CMJ) trials. Unit of Measurement: Centimeter (cm) - Highest jump height
Changes in Agility (seconds)
Time frame: before and at the end of the 11-week intervention.
Assessed via the Pro-Agility Test (20-yard shuttle run) using photocell timing gates. The total time to complete the right-left-center shuttle sequence was recorded. Unit of Measurement: Seconds (s) - Time to complete the test
Changes in Inhibitory Control (Number of correct responses and Reaction Time (ms))
Time frame: before and at the end of the 11-week intervention.
Inhibitory control was assessed using a computer-based Go/No-Go task, which measured participants' ability to suppress automatic motor responses. The task included 200 trials: 100 Go (letter X) and 100 No-Go (letter O) stimuli. Participants were instructed to press a button as quickly as possible for Go stimuli and withhold responses for No-Go stimuli. Key outcome variables included: Accuracy of correct responses to Go stimuli (AC-Go) Accuracy of correct inhibitions to No-Go stimuli (AC-NoGo) Mean reaction time for correct Go responses (Go RT) Unit of Measurement: Number of correct responses and reaction time in milliseconds (ms)
Changes in Planning and Problem-Solving Skills (Number of moves and seconds)
Time frame: before and at the end of the 11-week intervention.
Description: Executive function was assessed using a computer-based Tower of Hanoi task, designed to evaluate planning, problem-solving, and rule-based learning. Participants moved three disks across three pegs while following predefined rules to match a target configuration. Four outcome variables were recorded: Total number of moves Total time to solution (seconds) Average time per move (seconds) Latency to first move (planning time in seconds) Unit of Measurement: Number of moves and seconds (s)
Changes in Visuospatial Working Memory (correctly repeated number score)
Time frame: before and at the end of the 11-week intervention.
Description: The Corsi Block Test was used to evaluate visual working memory and attention. In this computerized task, participants were asked to reproduce increasingly complex sequences of illuminated blocks. The task terminated when the participant failed to correctly repeat sequences of a given length twice in a row. Unit of Measurement: Span score (maximum sequence length correctly repeated)
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 23 Apr 2025.
- Background: PubMed 29161988Lind RR, Geertsen SS, Orntoft C, Madsen M, Larsen MN, Dvorak J, Ritz C, Krustrup P. Improved cognitive performance in preadolescent Danish children after the school-based physical activity programme "FIFA 11 for Health" for Europe - A cluster-randomised controlled trial. Eur J Sport Sci. 2018 Feb;18(1):130-139. doi: 10.1080/17461391.2017.1394369. Epub 2017 Nov 21.
- Background: PubMed 32353906Madsen M, Elbe AM, Madsen EE, Ermidis G, Ryom K, Wikman JM, Rasmussen Lind R, Larsen MN, Krustrup P. The "11 for Health in Denmark" intervention in 10- to 12-year-old Danish girls and boys and its effects on well-being-A large-scale cluster RCT. Scand J Med Sci Sports. 2020 Sep;30(9):1787-1795. doi: 10.1111/sms.13704. Epub 2020 May 27.
- Derived from this study: PubMed 41673200Sendil AM, Canli U, Larsen MN, Tarantino G, Krustrup P, Aldhahi MI. Effects of the 11 for Health program on physical performance and executive functions in schoolchildren. Sci Rep. 2026 Feb 12;16(1):8439. doi: 10.1038/s41598-026-38837-5.
- Individual participant dataSharing planned: Yes. Measurements: Data obtained from physical fitness parameters (e.g., static, dynamic and proprioceptive balance, agility, countermovement jump) and executive function assessments (e.g., Go/No-Go, Tower of Hanoi, and Corsi Block tests) will be shared. Data Anonymization: All shared data will be fully anonymized to ensure participant confidentiality. Personal identifiers such as names, birth dates, and school affiliations will be removed. Data will be reviewed and aggregated where necessary to prevent the possibility of participant re-identification. Data Format: The data will be provided in standardized file formats such as CSV or Excel (.xlsx) to support compatibility and ease of use in secondary analyses. Access Control: Access to the shared IPD will be granted to qualified researchers who provide a valid research proposal and agree to comply with data use agreements that ensure the data will be used solely for research purposes and not for commercial gain.
Related trials for Physical Activity
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "11 for Health" training group in people with Physical Activity and Executive Function (Cognition), run by Namik Kemal University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 23 Apr 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 Turkey (Türkiye). 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?
Changes in Static Balance Performance (% Score) (time frame: before and at the end of the 11-week intervention.). The study lists 8 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 NCT06939881, which also lists 3 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 23 Apr 2025.