NCT06202924

Brief Summary

Joint hypermobility is a clinical condition characterized by joints having a range of motion beyond their normal limits. Joint hypermobility (JH) makes the joints more vulnerable to trauma in individuals with increased joint range of motion, changes in neuromuscular reflexes and decreased joint position sense. Individuals with JH have difficulty in stabilization and end of extension range of motion compared to healthy individuals. Accordingly, findings such as balance problems and an increased risk of falling occur in these patients. Recent evidence suggests that children and adults with JH may be identified with seemingly unrelated, common clinical problems such as chronic fatigue, anxiety, and a range of gastrointestinal functional disorders. The use of internal and external focus in learning motor skills is important in terms of performance and activity. In the external focus of attention (EF), attention is directed to movement and an environmental stimulus. In the internal focus (IF), attention is directed directly to body movements. In revealing positive effects in external focus; Methods such as metaphor, analogy, imaginary objects, mental analogies can be used. Adopting an external focus of attention (focusing on the effects of movements on the object or environment), as opposed to an internal focus of attention (focusing on body movements), has been found to significantly improve performance on a variety of tasks. For example, to improve balance performance, while a patient performs a single-leg balance task on a Bosu ball, the therapist may instruct the patient using an internal focus of attention such as "minimize movement of the feet." However, instructions can also be given externally by changing just one word, such as "minimize Bosu's movement." Additionally, a metaphor (e.g., "stand still as if stuck to Velcro"), analogy ("imagine being on top of a mountain, stay on the mountain!"), an object attached to the body ("keep the tape stuck to the chest still"), or the target of the movement An imaginary object (e.g., straight line) of which a mental image is obtained has been used within external focus instructions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 2, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2024

Completed
Last Updated

March 15, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

January 2, 2024

Last Update Submit

March 14, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Static balance assessment:

    Before starting the test, the body will be asked to position their center of gravity on the target point in as comfortable a position as possible on one leg. The dominant will be asked to stand in a single-leg stance on his legs and have his arms crossed over his shoulders. In the evaluation, participants will be asked to maintain their position on one leg with their eyes open for 20 seconds. The test will be performed 3 times and postural stability indices will be reported. Individuals will focus on their own feet while performing the internally focused static balance test. When participants switch to the externally focused test, subjects will be asked to focus on the rectangular paper placed under their feet. Additionally, individuals will be given static balance assessments without the use of any instructions/focus.

    1-3 months

  • Dynamic balance assessment:Y balance test

    Before starting the test, the leg lengths of the individuals will be measured from spina iliaca anterior superior (SIAS) to Medial malleolus. Then, the participants will be positioned in a standing position with one leg at the middle point of the Y-shaped platform created on the ground. Then, the patient will be asked to reach out to the directions in the test apparatus with his other extremity and touch them with his big toe. While participants focus on their own feet in the internally focused dynamic balance test, when participants switch to the externally focused test, subjects will be asked to lie down by focusing on the cone placed at the end of the test platform. The test will be performed 3 times in all directions and the averages will be recorded in cm. Additionally, individuals will receive dynamic balance assessments without the use of any instruction/focus.

    1-3 months

  • Isokinetic strength evaluation

    The angular values of the dynamometer and the platform on which the measurement will be made will be adjusted according to the reference values provided with the software. After the participant is placed on the platform, the overlap level of the rotation axis of the dynamometer and the anatomical axis of the knee joint will be checked. While performing the internally focused strength test, individuals will be asked to look at the quadriceps muscle previously taught by the researcher and will perform the test with this method. When the externally focused force test is started, participants will be asked to focus on the pad on the distal tibia to which subjects apply force. The total joint range of motion at which the test will be performed is determined as 0°-90°. Additionally, individuals will receive muscle strength assessments without the use of any instruction/focus.

    1-3 months

Interventions

Biodex stabilometer device will be used to evaluate the static balance of the participants.

Individuals' dynamic balance performances were evaluated with the Y balance test. Y balance test is a test method with proven validity and reliability in athletes and healthy subjects. (Intra-class correlation 0.99-1, Inter-class correlation 0.85-0.91).

Quadriceps muscle strength of the participants will be evaluated with an isokinetic dynamometer. Isokinetic dynamometers are considered the gold standard in muscle strength measurements. These devices have the ability to objectively report the amount of force produced by individuals at predetermined angular speed and joint range of motion.

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals between the ages of 18-35 who score 5 or more out of 9 according to the Beighton scoring will be included in the research. Among these individuals, those with any pathology related to the musculoskeletal system or a history of surgery within the last 6 months will be excluded from the study. The study will be initiated with individuals who volunteer for the study as a result of the inclusion and exclusion criteria. Individuals will be evaluated for static balance, dynamic balance and lower extremity muscle strength without the use of any instructions/focus. Then, individuals' static balance, dynamic balance and lower extremity muscle strength will be evaluated according to internal and external focus techniques, respectively.

You may qualify if:

  • Scored 5 out of 9 or more according to Beighton scoring
  • Individuals between the ages of 18-35 will be included in the research.

You may not qualify if:

  • These individuals do not have any pathology related to the musculoskeletal system
  • Those with a history of surgery within the last 6 months will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabia ZORLULAR

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

  • Smits-Engelsman B, Klerks M, Kirby A. Beighton score: a valid measure for generalized hypermobility in children. J Pediatr. 2011 Jan;158(1):119-23, 123.e1-4. doi: 10.1016/j.jpeds.2010.07.021. Epub 2010 Sep 17.

  • Engelbert RH, Bank RA, Sakkers RJ, Helders PJ, Beemer FA, Uiterwaal CS. Pediatric generalized joint hypermobility with and without musculoskeletal complaints: a localized or systemic disorder? Pediatrics. 2003 Mar;111(3):e248-54. doi: 10.1542/peds.111.3.e248.

  • Lohse KR. The influence of attention on learning and performance: pre-movement time and accuracy in an isometric force production task. Hum Mov Sci. 2012 Feb;31(1):12-25. doi: 10.1016/j.humov.2011.06.001. Epub 2011 Jul 20.

  • Zachry T, Wulf G, Mercer J, Bezodis N. Increased movement accuracy and reduced EMG activity as the result of adopting an external focus of attention. Brain Res Bull. 2005 Oct 30;67(4):304-9. doi: 10.1016/j.brainresbull.2005.06.035.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Muscle Strength and Balance Assessment

MeSH Terms

Conditions

Joint Instability

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Ali ZORLULAR

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 2, 2024

First Posted

January 12, 2024

Study Start

January 15, 2024

Primary Completion

March 14, 2024

Study Completion

March 14, 2024

Last Updated

March 15, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations