NCT07044999

Brief 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. 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

1 month

First QC Date

June 22, 2025

Last Update Submit

June 22, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Performance in the One-Leg Stance Test

    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

    Evaluates lower extremity muscle endurance and functional strength under cognitive load

    0 day

  • Performance in the Timed Up and Go (TUG) test

    Measures dynamic balance, mobility, and the ability to maintain performance during divided attention.

    0 day

  • Dual Task Cost (DTC) percentage

    Quantifies the percentage change in performance when a cognitive task is added, reflecting dual-task interference.

    0 day

Secondary Outcomes (3)

  • Berg Balance Scale (BBS):

    0 day

  • Activities-specific Balance Confidence Scale (ABC-16)

    0 day

  • Falls Efficacy Scale-International (FES-I):

    0 day

Study Arms (2)

patients with hypermobility

Other: no intervention

Control group

Other: no intervention

Interventions

no intervention

Control grouppatients with hypermobility

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

hypermobile patients and healthy controls

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

June 22, 2025

First Posted

July 1, 2025

Study Start

July 1, 2025

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

July 1, 2025

Record last verified: 2025-06