Generalized Joint HypermobilityNCT06988631
Sensorimotor Organization in Individuals With General Joint Hypermobility
A study testing Sensory treatment and foot care booklet in people with Generalized Joint Hypermobility, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This study is the first to examine the effect of sole sensory training on sensorimotor organization in individuals with GEH. Individuals with a Beighton score of 5 and above were included in the study. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Generalized Joint Hypermobility
- What is being tested?
- Sensory treatment and foot care booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 15 Dec 2024
- Phase
- Interventional
- 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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Persons with a Beighton score ≥5 without any systemic disease
- Asymptomatic persons
Who cannot join
- People who have had an upper or lower extremity injury in the last 3 months,
- People who have a history of fractures or surgery in the last year,
- People who have been pregnant in the last year,
- Those diagnosed with Ehlers-Danlos Syndrome (EDS), hypermobile Ehlers-Danlos syndrome (hEDS), or hypermobility spectrum disorders (HSD)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzurum technical university
Erzurum, State/Province, 25200
About this study
Official title: Investigation of the Effect of Foot Sole Sensory Training on Sensorimotor Organization in Individuals With General Joint Hypermobility
This study is the first to examine the effect of sole sensory training on sensorimotor organization in individuals with GEH. Individuals with a Beighton score of 5 and above were included in the study. Within the scope of the study, individuals with general joint hypermobility (GEH) were divided into intervention and control groups by the Randomization method. The intervention group received sole sensory training in the home environment. Both groups were given a foot care brochure. The individuals' sole sensory and balance skills were evaluated before and after the intervention. As a result of the study, the intervention aimed to prevent injuries and disabilities that may occur due to joint laxity by improving sole sensory and balance.
- Conditions
- Generalized Joint Hypermobility
- Being tested
- Sensory treatment, foot care booklet
- Keywords
- joint hypermobility, food sense, Sensorimotor
- Medical subject headings
- Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory treatmentOther
Participants were asked to practice the foot sole sensory training program at home every day for 2 weeks.
foot care bookletOther
Participants were given a booklet about healthy feet and were informed.
| Study group | Role | What they receive |
|---|---|---|
| Kontrol group | Active comparator | Participants were given brochures and training on foot care and health. Receives: Other: foot care booklet |
| exercise group | Experimental | Participants were asked to practice the foot sole sensory training program at home every day for 2 weeks. Receives: Other: Sensory treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Light touch sensation
It was evaluated using the Semmes-Weinstein Monofilament (SWM) test kit.
Measured: 2 weeks
Two-Point Separation sensation
A discriminator was used to assess two-point discrimination perception.
Measured: 2 weeks
Vibration sense
A 128 Hz tuning fork was used to evaluate vibration sensation.
Measured: 2 weeks
Secondary outcomes (3)
Proprioception
Joint position sense test for proprioception assessment was performed using a digital goniometer device.
Measured: 2 weeks
Muscle Strength
A hand-held dynamometer (Lafayette Instrument®, Layafette, IN) was used to determine muscle strength for both lower extremities of the individuals.
Measured: 2 weeks
Balance
Dynamic balance of individuals was assessed with the Y Balance Test.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start15 Jan 2024
- Primary completion15 Nov 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Simsek, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988631
- Sponsor's protocol ID
- 16/07/28.12.2023
- Status last verified
- May 2025
- First submitted
- 16 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Foot Sole Sensory Training on Sensorimotor Organization in Individuals With General Joint Hypermobility
- ClinicalTrials.gov ID
- NCT06988631
- Acronym / sponsor ID
- 16/07/28.12.2023
- Conditions
- Generalized Joint Hypermobility
- Keywords
- joint hypermobility, food sense, Sensorimotor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 25 May 2025 (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.
This study is the first to examine the effect of sole sensory training on sensorimotor organization in individuals with GEH. Individuals with a Beighton score of 5 and above were included in the study. Within the scope of the study, individuals with general joint hypermobility (GEH) were divided into intervention and control groups by the Randomization method. The intervention group received sole sensory training in the home environment. Both groups were given a foot care brochure. The individuals' sole sensory and balance skills were evaluated before and after the intervention. As a result of the study, the intervention aimed to prevent injuries and disabilities that may occur due to joint laxity by improving sole sensory and balance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kontrol group | Active comparator | Other: foot care bookletParticipants were given brochures and training on foot care and health. |
| exercise group | Experimental | Other: Sensory treatmentParticipants were asked to practice the foot sole sensory training program at home every day for 2 weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Persons with a Beighton score ≥5 without any systemic disease
- Asymptomatic persons
Key exclusion criteria (4 listed)
- People who have had an upper or lower extremity injury in the last 3 months,
- People who have a history of fractures or surgery in the last year,
- People who have been pregnant in the last year,
- Those diagnosed with Ehlers-Danlos Syndrome (EDS), hypermobile Ehlers-Danlos syndrome (hEDS), or hypermobility spectrum disorders (HSD)
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 |
|---|---|---|
| Sensory treatmentParticipants were asked to practice the foot sole sensory training program at home every day for 2 weeks. | Other | exercise group |
| foot care bookletParticipants were given a booklet about healthy feet and were informed. | Other | Kontrol group |
Primary outcome
Light touch sensation
Time frame: 2 weeks
It was evaluated using the Semmes-Weinstein Monofilament (SWM) test kit.
Two-Point Separation sensation
Time frame: 2 weeks
A discriminator was used to assess two-point discrimination perception.
Vibration sense
Time frame: 2 weeks
A 128 Hz tuning fork was used to evaluate vibration sensation.
3 secondary outcomes
Proprioception
Time frame: 2 weeks
Muscle Strength
Time frame: 2 weeks
Balance
Time frame: 2 weeks
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 25 May 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory treatment and foot care booklet in people with Generalized Joint Hypermobility, 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 4 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 25 May 2025. 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?
Light touch sensation (time frame: 2 weeks). 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?
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 25 May 2025; AzTrials last refreshed its copy on 2 Nov 2026.