Hypermobility, JointNCT05896722
"Core" Muscle Endurance, Upper Extremity Muscle Strength, Grip Strength, and Hand-eye Coordination in Generalized Joint Hypermobility
An observational study of Hypermobility, Joint and Muscle Weakness, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Every individual with joint hypermobility may not apply to a health institution because they do not have a complaint that will affect their daily life. Although hypermobility is a common clinical entity in the society, this issue has not been fully understood yet. Read more about this study
- Who is it for?
- Ages 17 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypermobility, Joint, Muscle Weakness, Coordination Lack
- What is being tested?
- Core muscle endurance, Upper extremity muscle strength and Grip strength
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Apr 2023to 18 Sep 2023
- How long will I take part?
- 1 Day
- 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 17 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Young adults between the ages of 17-26 years with a score of 4 or higher according to the Beighton criteria.
Who may be able to join
- Getting a score of 4 or higher according to the Beighton criteria
- Being between the ages of 17-26
Who cannot join
- Presence of benign joint hypermobility syndrome
- Presence of any neurological, rheumatic, musculoskeletal, metabolic and connective tissue disease
- History of fracture in the upper extremity
- History of pain, deformity or surgery associated with the vertebral column and upper extremity
- Presence of cognitive, mental and/or serious psychiatric illness
- Participating in any exercise program or sportive activity in the last six months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Core Muscle Endurance, Upper Extremity Muscle Strength, Grip Strength, and Hand-eye Coordination in Young Adults With Generalized Joint Hypermobility
Every individual with joint hypermobility may not apply to a health institution because they do not have a complaint that will affect their daily life. Although hypermobility is a common clinical entity in the society, this issue has not been fully understood yet. In particular, individuals with GJH are either neglected in physiotherapy and rehabilitation evaluations and practices, or they encounter an incomplete assessment and physiotherapy practices. In this study, in order to better understand the effect of GJH on "core" muscle endurance, upper extremity strength, grip strength and coordination, we will include the individuals identified GJH among the university students (hypermobility severity ≥4/9 according to Beighton diagnostic criteria) as study group and the healthy peers as control group. We believe the results we will obtain at the end of our study will make a contribution to the literature in terms of revealing the role of "core" muscle endurance and upper extremity strength, grip strength and coordination in the evaluation and rehabilitation of individuals with GJH. In addition, it will contribute to the inclusion of individuals with GJH who are professional athletes, dancers or musicians in a more comprehensive evaluation program and the creation of physiotherapy and rehabilitation programs.
According to the information we have obtained from the literature, it is a fact that hypermobility can increase the susceptibility to musculoskeletal system diseases. For this reason, early solutions to problems can be provided by evaluating hypermobility in patients who apply to health institutions with various musculoskeletal complaints, raising awareness of patients with hypermobility to prevent injuries caused by hypermobility, and strengthening muscles.
Read the detailed description
Many people may have more than one hypermobile joint, and when certain conditions are met, this condition called generalized joint hypermobility (GJH) is not detrimental. In recent years, the spectrum of the disorder has been changed in the classification of joint hypermobility, from asymptomatic GJH to the multisystem involvement and painful condition called hypermobile Ehlers Danlos Syndrome. Beighton criteria are most commonly used in the diagnosis of hypermobility. The Beighton score is an easy scoring method that is scored by performing five maneuvers and includes a total of nine points. If four of these maneuvers are positive, the patient is considered to have hypermobility. Numerous studies associate hypermobility with conditions such as soft tissue injuries, pain, joint instability, decreased soft tissue strength, increased frequency of traumatic injuries, and pain-related inactivity.
The study was designed as a cross-sectional descriptive and comparative study. With this study, in order to better understand the effect of GJH on core muscle endurance, upper extremity strength, grip strength, and coordination, we aim to include volunteers with identified GEH among the university students (hypermobility severity ≥4/9 according to Beighton diagnostic criteria). 27 students between the ages of 17-26 who are studying at the Faculty of Health Sciences of Bezmialem Vakif University and scored 4 and above according to the Beighton score, and the 27 students who are in the same age group studying at the same faculty, do not have GJH will be included. In the study, after evaluating flexibility with sit-reach test, core muscle endurance, upper extremity muscle strength, hand grip strength, finger grip strength and hand-eye coordination tests will be applied to all participants. SPSS v.20 program will be used for data analysis. All data will be analyzed with the Kolmogorov-Smirnov test to determine the distribution characteristics. In the study, descriptive statistics (mean±standard deviation, minimum-maximum, number and percentile) will be given for discrete and continuous variables. When the differences between two independent groups are evaluated, "t-Test in Independent Groups" in case the parametric test prerequisites are met; If not, the "Mann Whitney -U Test" will be used. "Chi-Square Test" will be used to determine the relationships between two discrete variables. When the variables meet the parametric test prerequisites, the correlation coefficients and statistical significance will be calculated with the "Pearson Test", when they do not, the correlation coefficients and statistical significance for the relations between the variables will be calculated with the "Spearman Test".
Although there are studies in the literature evaluating muscle strength, grip strength and trunk endurance in individuals with joint hypermobility, no study evaluating hand-eye coordination has been encountered. However, no study has been encountered that evaluated core muscle endurance, upper extremity strength, grip strength, and hand-eye coordination in individuals with GJH. We believe that the results we will obtain at the end of our study will contribute to the literature in terms of revealing the role of core muscle endurance and upper extremity strength, grip and coordination in the evaluation and rehabilitation of individuals with GJH.
- Conditions
- Hypermobility, Joint, Muscle Weakness, Coordination Lack
- Being tested
- Core muscle endurance, Upper extremity muscle strength, Grip strength, Pinch strength, Alternate hand-wall toss test
- Medical subject headings
- Joint Instability, Muscle Weakness, Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core muscle enduranceOther
Trunk flexion, trunk extension, side bridge exercises and prone bridge test developed by McGill will be used to evaluate core muscle endurance.
Upper extremity muscle strengthOther
Isometric muscle strength assessment of the shoulder, elbow and wrist muscles will be performed with a hand-held dynamometer.
Grip strengthOther
Grip strength will be evaluated with a hand dynamometer in the position recommended by the American Association of Hand Therapists.
Pinch strengthOther
Pinch strength will be evaluated with a pinchmeter in three positions.
Alternate hand-wall toss testOther
To measure hand-eye coordination, it is performed by changing hands by throwing and catching the ball against the wall.
| Study group | Role | What they receive |
|---|---|---|
| Study group | 27 young adults aged 17-26 who scored 4 or more according to the Beighton scoring Receives: Other: Core muscle endurance; Other: Upper extremity muscle strength; Other: Grip strength; Other: Pinch strength; Other: Alternate hand-wall toss test | |
| Control group | 27 young adults aged 17-26 who scored less than 4 points according to the Beighton scoring Receives: Other: Core muscle endurance; Other: Upper extremity muscle strength; Other: Grip strength; Other: Pinch strength; Other: Alternate hand-wall toss test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alternate hand-wall toss test
To measure hand-eye coordination, it is performed by changing hands by throwing and catching the ball against the wall. The action is repeated for a period of 30 seconds.
Measured: One day
Core muscle endurance tests
Trunk flexion, trunk extension, side bridge exercises and prone bridge test developed by McGill will be used to evaluate core muscle endurance.
Measured: One day
Secondary outcomes (3)
Upper extremity muscle strength measurement
Isometric muscle strength assessment of the shoulder, elbow and wrist muscles will be performed with a hand-held dynamometer.
Measured: One day
Grip strength measurement
Grip strength will be evaluated with a hand grip dynamometer in the position recommended by the American Association of Hand Therapists.
Measured: One day
Pinch strength measurement
It will be evaluated with a pinchmeter. Measurements will be made bilaterally in three different positions as lateral, palmar and fingertip grips.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start25 Apr 2023
- Primary completion1 Sep 2023
- Study completion18 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypermobility, JointStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 54 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Tuncer, Bezmialem Vakif University
- Investigators
- Deniz Tuncer, PhD, PT, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896722
- Sponsor's protocol ID
- DT-03
- Status last verified
- Sep 2023
- First submitted
- 8 May 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Core Muscle Endurance, Upper Extremity Muscle Strength, Grip Strength, and Hand-eye Coordination in Young Adults With Generalized Joint Hypermobility
- ClinicalTrials.gov ID
- NCT05896722
- Acronym / sponsor ID
- DT-03
- Conditions
- Hypermobility, Joint, Muscle Weakness, Coordination Lack
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 9 Jun 2023 (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.
Every individual with joint hypermobility may not apply to a health institution because they do not have a complaint that will affect their daily life. Although hypermobility is a common clinical entity in the society, this issue has not been fully understood yet. In particular, individuals with GJH are either neglected in physiotherapy and rehabilitation evaluations and practices, or they encounter an incomplete assessment and physiotherapy practices. In this study, in order to better understand the effect of GJH on "core" muscle endurance, upper extremity strength, grip strength and coordination, we will include the individuals identified GJH among the university students (hypermobility severity ≥4/9 according to Beighton diagnostic criteria) as study group and the healthy peers as control group. We believe the results we will obtain at the end of our study will make a contribution to the literature in terms of revealing the role of "core" muscle endurance and upper extremity strength, grip strength and coordination in the evaluation and rehabilitation of individuals with GJH. In addition, it will contribute to the inclusion of individuals with GJH who are professional athletes, dancers or musicians in a more comprehensive evaluation program and the creation of physiotherapy and rehabilitation programs.
According to the information we have obtained from the literature, it is a fact that hypermobility can increase the susceptibility to musculoskeletal system diseases. For this reason, early solutions to problems can be provided by evaluating hypermobility in patients who apply to health institutions with various musculoskeletal complaints, raising awareness of patients with hypermobility to prevent injuries caused by hypermobility, and strengthening muscles.
Detailed description
Many people may have more than one hypermobile joint, and when certain conditions are met, this condition called generalized joint hypermobility (GJH) is not detrimental. In recent years, the spectrum of the disorder has been changed in the classification of joint hypermobility, from asymptomatic GJH to the multisystem involvement and painful condition called hypermobile Ehlers Danlos Syndrome. Beighton criteria are most commonly used in the diagnosis of hypermobility. The Beighton score is an easy scoring method that is scored by performing five maneuvers and includes a total of nine points. If four of these maneuvers are positive, the patient is considered to have hypermobility. Numerous studies associate hypermobility with conditions such as soft tissue injuries, pain, joint instability, decreased soft tissue strength, increased frequency of traumatic injuries, and pain-related inactivity.
The study was designed as a cross-sectional descriptive and comparative study. With this study, in order to better understand the effect of GJH on core muscle endurance, upper extremity strength, grip strength, and coordination, we aim to include volunteers with identified GEH among the university students (hypermobility severity ≥4/9 according to Beighton diagnostic criteria). 27 students between the ages of 17-26 who are studying at the Faculty of Health Sciences of Bezmialem Vakif University and scored 4 and above according to the Beighton score, and the 27 students who are in the same age group studying at the same faculty, do not have GJH will be included. In the study, after evaluating flexibility with sit-reach test, core muscle endurance, upper extremity muscle strength, hand grip strength, finger grip strength and hand-eye coordination tests will be applied to all participants. SPSS v.20 program will be used for data analysis. All data will be analyzed with the Kolmogorov-Smirnov test to determine the distribution characteristics. In the study, descriptive statistics (mean±standard deviation, minimum-maximum, number and percentile) will be given for discrete and continuous variables. When the differences between two independent groups are evaluated, "t-Test in Independent Groups" in case the parametric test prerequisites are met; If not, the "Mann Whitney -U Test" will be used. "Chi-Square Test" will be used to determine the relationships between two discrete variables. When the variables meet the parametric test prerequisites, the correlation coefficients and statistical significance will be calculated with the "Pearson Test", when they do not, the correlation coefficients and statistical significance for the relations between the variables will be calculated with the "Spearman Test".
Although there are studies in the literature evaluating muscle strength, grip strength and trunk endurance in individuals with joint hypermobility, no study evaluating hand-eye coordination has been encountered. However, no study has been encountered that evaluated core muscle endurance, upper extremity strength, grip strength, and hand-eye coordination in individuals with GJH. We believe that the results we will obtain at the end of our study will contribute to the literature in terms of revealing the role of core muscle endurance and upper extremity strength, grip and coordination in the evaluation and rehabilitation of individuals with GJH.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Core muscle endurance, Other: Upper extremity muscle strength, Other: Grip strength, Other: Pinch strength, Other: Alternate hand-wall toss test27 young adults aged 17-26 who scored 4 or more according to the Beighton scoring |
| Control group | – | Other: Core muscle endurance, Other: Upper extremity muscle strength, Other: Grip strength, Other: Pinch strength, Other: Alternate hand-wall toss test27 young adults aged 17-26 who scored less than 4 points according to the Beighton scoring |
Who may qualify
- Ages
- 17 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Young adults between the ages of 17-26 years with a score of 4 or higher according to the Beighton criteria.
Key inclusion criteria (2 listed)
- Getting a score of 4 or higher according to the Beighton criteria
- Being between the ages of 17-26
Key exclusion criteria (6 listed)
- Presence of benign joint hypermobility syndrome
- Presence of any neurological, rheumatic, musculoskeletal, metabolic and connective tissue disease
- History of fracture in the upper extremity
- History of pain, deformity or surgery associated with the vertebral column and upper extremity
- Presence of cognitive, mental and/or serious psychiatric illness
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 |
|---|---|---|
| Core muscle enduranceTrunk flexion, trunk extension, side bridge exercises and prone bridge test developed by McGill will be used to evaluate core muscle endurance. | Other | Control group, Study group |
| Upper extremity muscle strengthIsometric muscle strength assessment of the shoulder, elbow and wrist muscles will be performed with a hand-held dynamometer. | Other | Control group, Study group |
| Grip strengthGrip strength will be evaluated with a hand dynamometer in the position recommended by the American Association of Hand Therapists. | Other | Control group, Study group |
| Pinch strengthPinch strength will be evaluated with a pinchmeter in three positions. | Other | Control group, Study group |
| Alternate hand-wall toss testTo measure hand-eye coordination, it is performed by changing hands by throwing and catching the ball against the wall. | Other | Control group, Study group |
Primary outcome
Alternate hand-wall toss test
Time frame: One day
To measure hand-eye coordination, it is performed by changing hands by throwing and catching the ball against the wall. The action is repeated for a period of 30 seconds.
Core muscle endurance tests
Time frame: One day
Trunk flexion, trunk extension, side bridge exercises and prone bridge test developed by McGill will be used to evaluate core muscle endurance.
3 secondary outcomes
Upper extremity muscle strength measurement
Time frame: One day
Grip strength measurement
Time frame: One day
Pinch strength measurement
Time frame: One day
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 21 Sep 2023.
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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.
Deniz Tuncer, PhD, PT principal investigator
Bezmialem Vakif University
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 Hypermobility, Joint and Muscle Weakness, run by Bezmialem Vakif 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 6 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 21 Sep 2023. 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?
Alternate hand-wall toss test (time frame: One day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2023.