Evaluation of Balance and Physical Performance Under Dual Task Conditions in Individuals With and Without Generalized Joint Hypermobility

June 22, 2025 updated by: Busra Sirin, Beylikduzu State Hospital
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

hypermobile patients and healthy controls

Description

Inclusion Criteria:

  • Aged between 18 and 40 years
  • A Beighton score of 4 or higher (indicative of Generalized Joint Hypermobility)
  • Willingness to participate in the study

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control group
Other: no intervention
no intervention
patients with hypermobility
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
0 day
Performance in the 30-Second Sit-to-Stand Test
Time Frame: 0 day
Evaluates lower extremity muscle endurance and functional strength under cognitive load
0 day
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.
0 day
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.
0 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Berg Balance Scale (BBS):
Time Frame: 0 day
Provides a comprehensive evaluation of functional balance through various static and dynamic tasks. The maximum score is 56. Higher scores indicate that good balance.
0 day
Activities-specific Balance Confidence Scale (ABC-16)
Time Frame: 0 day
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.
0 day
Falls Efficacy Scale-International (FES-I):
Time Frame: 0 day
Assesses fear of falling during daily life activities, indicating fall-related psychological concerns. Higher scores indicate that high degree fear of falling
0 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beylikduzu State Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BeylikduzuStateH22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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