Hypermobility SyndromeNCT07044999
Evaluation of Balance and Physical Performance Under Dual Task Conditions in Individuals With and Without Generalized Joint Hypermobility
An observational study of Hypermobility Syndrome, run by Beylikduzu State Hospital.
Trial summary
This study aims to evaluate balance and physical performance under dual task conditions in individuals with and without Generalized Joint Hypermobility (GJH), as determined by the Beighton score. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Hypermobility Syndrome
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Aug 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 18 to 40 years
- All sexes
- Adult
Study population: hypermobile patients and healthy controls
Who may be able to join
- Aged between 18 and 40 years
- A Beighton score of 4 or higher (indicative of Generalized Joint Hypermobility)
- Willingness to participate in the study
Who cannot join
- Younger than 18 or older than 40 years
- Presence of neurological disorders (e.g., stroke, multiple sclerosis, peripheral neuropathy)
- History of vestibular system disorders (e.g., benign paroxysmal positional vertigo, vestibular neuritis)
- History of orthopedic conditions affecting the lower extremities (e.g., fracture, joint replacement, ligament injury)
- Cognitive impairment preventing the execution of cognitive tasks
- Diagnosis of systemic musculoskeletal diseases (e.g., rheumatoid arthritis, Ehlers-Danlos syndrome)
- Pregnancy
- Participation in balance training or neurological/physiotherapy programs within the last 6 months
About this study
This study aims to evaluate balance and physical performance under dual task conditions in individuals with and without Generalized Joint Hypermobility (GJH), as determined by the Beighton score. All participants will undergo the One-Leg Stance Test and 30-Second Sit-to-Stand Test under both single-task (balance only) and dual-task (simultaneous cognitive task) conditions. The cognitive task will involve counting backward by sevens from a given number. Participants will also complete the Timed Up and Go (TUG) test under both single- and dual-task conditions. Additionally, the Berg Balance Scale (BBS) will be used for comprehensive balance assessment. Balance confidence will be evaluated using the Activities-specific Balance Confidence Scale (ABC-16), and fear of falling will be assessed with the Falls Efficacy Scale-International (FES-I). Changes in performance under dual-task conditions will be expressed as a percentage using the Dual Task Cost (DTC) formula
- Conditions
- Hypermobility Syndrome
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| patients with hypermobility | Not described Receives: Other: no intervention | |
| Control group | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance in the One-Leg Stance Test
Assesses static balance capacity and the impact of a simultaneous cognitive task on postural control.
Measured: 0 day
Performance in the 30-Second Sit-to-Stand Test
Evaluates lower extremity muscle endurance and functional strength under cognitive load
Measured: 0 day
Performance in the Timed Up and Go (TUG) test
Measures dynamic balance, mobility, and the ability to maintain performance during divided attention.
Measured: 0 day
Dual Task Cost (DTC) percentage
Quantifies the percentage change in performance when a cognitive task is added, reflecting dual-task interference.
Measured: 0 day
Secondary outcomes (3)
Berg Balance Scale (BBS):
Provides a comprehensive evaluation of functional balance through various static and dynamic tasks. The maximum score is 56. Higher scores indicate that good balance.
Measured: 0 day
Activities-specific Balance Confidence Scale (ABC-16)
Reflects the individual's perceived confidence in performing daily activities without losing balance.The maximum score is 100, the minimum score is 0. Higher scores indicate that high confidence patient's balance.
Measured: 0 day
Falls Efficacy Scale-International (FES-I):
Assesses fear of falling during daily life activities, indicating fall-related psychological concerns. Higher scores indicate that high degree fear of falling
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypermobility SyndromeStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Beylikduzu State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Sirin, Beylikduzu State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044999
- Sponsor's protocol ID
- BeylikduzuStateH22
- Status last verified
- Jun 2025
- First submitted
- 22 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Balance and Physical Performance Under Dual Task Conditions in Individuals With and Without Generalized Joint Hypermobility
- ClinicalTrials.gov ID
- NCT07044999
- Acronym / sponsor ID
- BeylikduzuStateH22
- Conditions
- Hypermobility Syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Beylikduzu State HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 1 Jul 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.
This study aims to evaluate balance and physical performance under dual task conditions in individuals with and without Generalized Joint Hypermobility (GJH), as determined by the Beighton score. All participants will undergo the One-Leg Stance Test and 30-Second Sit-to-Stand Test under both single-task (balance only) and dual-task (simultaneous cognitive task) conditions. The cognitive task will involve counting backward by sevens from a given number. Participants will also complete the Timed Up and Go (TUG) test under both single- and dual-task conditions. Additionally, the Berg Balance Scale (BBS) will be used for comprehensive balance assessment. Balance confidence will be evaluated using the Activities-specific Balance Confidence Scale (ABC-16), and fear of falling will be assessed with the Falls Efficacy Scale-International (FES-I). Changes in performance under dual-task conditions will be expressed as a percentage using the Dual Task Cost (DTC) formula
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with hypermobility | – | Other: no intervention |
| Control group | – | Other: no intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- hypermobile patients and healthy controls
Key inclusion criteria (3 listed)
- Aged between 18 and 40 years
- A Beighton score of 4 or higher (indicative of Generalized Joint Hypermobility)
- Willingness to participate in the study
Key exclusion criteria (8 listed)
- Younger than 18 or older than 40 years
- Presence of neurological disorders (e.g., stroke, multiple sclerosis, peripheral neuropathy)
- History of vestibular system disorders (e.g., benign paroxysmal positional vertigo, vestibular neuritis)
- History of orthopedic conditions affecting the lower extremities (e.g., fracture, joint replacement, ligament injury)
- Cognitive impairment preventing the execution of cognitive tasks
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 |
|---|---|---|
| no interventionno intervention | Other | Control group, patients with hypermobility |
Primary outcome
Performance in the One-Leg Stance Test
Time frame: 0 day
Assesses static balance capacity and the impact of a simultaneous cognitive task on postural control.
Performance in the 30-Second Sit-to-Stand Test
Time frame: 0 day
Evaluates lower extremity muscle endurance and functional strength under cognitive load
Performance in the Timed Up and Go (TUG) test
Time frame: 0 day
Measures dynamic balance, mobility, and the ability to maintain performance during divided attention.
Dual Task Cost (DTC) percentage
Time frame: 0 day
Quantifies the percentage change in performance when a cognitive task is added, reflecting dual-task interference.
3 secondary outcomes
Berg Balance Scale (BBS):
Time frame: 0 day
Activities-specific Balance Confidence Scale (ABC-16)
Time frame: 0 day
Falls Efficacy Scale-International (FES-I):
Time frame: 0 day
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 1 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypermobility Syndrome, run by Beylikduzu State Hospital.
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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Performance in the One-Leg Stance Test (time frame: 0 day). The study lists 4 primary outcomes in all. 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 1 Jul 2025.