Joint HypermobilityNCT06202924
Muscle Strength and Balance in Individuals With Joint Hypermobility
An observational study of Joint Hypermobility and Balance, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Joint Hypermobility, Balance, Muscle Strength
- What is being tested?
- Static balance assessment, Dynamic balance assessment: and Isokinetic strength evaluation:
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 14 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 35 years
- All sexes
- Adult
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.
Who may be able to join
- Scored 5 out of 9 or more according to Beighton scoring
- Individuals between the ages of 18-35 will be included in the research.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Attention Focus on Muscle Strength and Balance in Individuals With Joint Hypermobility
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.
Read the detailed description
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 (external focus) EF 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 benefit of an external focus of attention compared to an internal focus of attention to enhance motor skill learning and performance has been consistently demonstrated by a large body of evidence across different populations, tasks, and skill levels . These developments included tasks such as balance, running, agility performance, direction changing performance, force production, horizontal and vertical jumping performance. In general, an external focus of attention has been shown to produce more accurate performance, improved reaction time, and more efficient movement (e.g., reduced muscle activity). According to the constrained action hypothesis, an IF encourages broader involvement of cognitive processes due to greater reliance on conscious control strategies. These strategies interfere with the normal automatic control processes of the motor system. An EF, on the other hand, encourages these automatic control processes, thus further enhancing motor learning. With the use of external focus of attention in neuromuscular training; It has been stated that in addition to improving motor performance and biomechanical changes, the connection between the sensory areas of the brain and the thalamus has increased. It has been found to possibly reduce "noise" in the central nervous system that interferes with fine movement control and affects the outcome of movement; dopamine availability may increase, which may strengthen memory by increasing synaptogenesis processes; It has been stated in publications that newly learned motor skills can be preserved and resistance to stress and fatigue can be achieved. Considering all these situations, investigators think that young individuals with joint hypermobility may have problems with muscle strength and balance skills, which are among the physical fitness parameters. It is important to optimally evaluate physical fitness parameters in order to prevent injuries and ensure the effectiveness of the modalities used in treatment. This study was planned to investigate whether external focus of attention is effective in revealing balance skills and muscle strength at an optimal level compared to internal focus of attention in individuals with joint hypermobility.
- Conditions
- Joint Hypermobility, Balance, Muscle Strength
- Being tested
- Static balance assessment, Dynamic balance assessment:, Isokinetic strength evaluation:
- Medical subject headings
- Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static balance assessmentBehavioural
Biodex stabilometer device will be used to evaluate the static balance of the participants.
Dynamic balance assessment:Behavioural
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).
Isokinetic strength evaluation:Behavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start15 Jan 2024
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Joint HypermobilityStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali ZORLULAR, Gazi University
- Investigators
- Ali ZORLULAR, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202924
- Sponsor's protocol ID
- Joint Hypermobility
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20850761Engelbert 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.
PubMed 12612280Lohse 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.
PubMed 21777989Zachry 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.
PubMed 16182938
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Attention Focus on Muscle Strength and Balance in Individuals With Joint Hypermobility
- ClinicalTrials.gov ID
- NCT06202924
- Acronym / sponsor ID
- Joint Hypermobility
- Conditions
- Joint Hypermobility, Balance, Muscle Strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 12 Jan 2024 (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.
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.
Detailed description
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 (external focus) EF 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 benefit of an external focus of attention compared to an internal focus of attention to enhance motor skill learning and performance has been consistently demonstrated by a large body of evidence across different populations, tasks, and skill levels . These developments included tasks such as balance, running, agility performance, direction changing performance, force production, horizontal and vertical jumping performance. In general, an external focus of attention has been shown to produce more accurate performance, improved reaction time, and more efficient movement (e.g., reduced muscle activity). According to the constrained action hypothesis, an IF encourages broader involvement of cognitive processes due to greater reliance on conscious control strategies. These strategies interfere with the normal automatic control processes of the motor system. An EF, on the other hand, encourages these automatic control processes, thus further enhancing motor learning. With the use of external focus of attention in neuromuscular training; It has been stated that in addition to improving motor performance and biomechanical changes, the connection between the sensory areas of the brain and the thalamus has increased. It has been found to possibly reduce "noise" in the central nervous system that interferes with fine movement control and affects the outcome of movement; dopamine availability may increase, which may strengthen memory by increasing synaptogenesis processes; It has been stated in publications that newly learned motor skills can be preserved and resistance to stress and fatigue can be achieved. Considering all these situations, investigators think that young individuals with joint hypermobility may have problems with muscle strength and balance skills, which are among the physical fitness parameters. It is important to optimally evaluate physical fitness parameters in order to prevent injuries and ensure the effectiveness of the modalities used in treatment. This study was planned to investigate whether external focus of attention is effective in revealing balance skills and muscle strength at an optimal level compared to internal focus of attention in individuals with joint hypermobility.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Scored 5 out of 9 or more according to Beighton scoring
- Individuals between the ages of 18-35 will be included in the research.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Static balance assessmentBiodex stabilometer device will be used to evaluate the static balance of the participants. | Behavioural | – |
| Dynamic balance assessment: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). | Behavioural | – |
| Isokinetic strength evaluation: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. | Behavioural | – |
Primary outcome
Static balance assessment:
Time frame: 1-3 months
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.
Dynamic balance assessment:Y balance test
Time frame: 1-3 months
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.
Isokinetic strength evaluation
Time frame: 1-3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Results publication: PubMed 20850761Smits-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.
- Results publication: PubMed 12612280Engelbert 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.
- Results publication: PubMed 21777989Lohse 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.
- Results publication: PubMed 16182938Zachry 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ali ZORLULAR principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint Hypermobility and Balance, run by Gazi University at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Static balance assessment: (time frame: 1-3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06202924, which also lists 4 linked publications.
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 15 Mar 2024.