- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07044999
- Original Trial
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
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
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
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 |
Intervention / Treatment |
|---|---|
|
Control group
|
no intervention
|
|
patients with hypermobility
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
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
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
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)
July 1, 2025
Primary Completion (Estimated)
August 1, 2025
Study Completion (Estimated)
August 1, 2025
Study Registration Dates
First Submitted
June 22, 2025
First Submitted That Met QC Criteria
June 22, 2025
First Posted (Estimated)
July 1, 2025
Study Record Updates
Last Update Posted (Estimated)
July 1, 2025
Last Update Submitted That Met QC Criteria
June 22, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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