Hypermobility, JointNCT05573880
The Influence of Whole-body Vibration Training on Postural Stability in People With Generalized Joint Hypermobility
A study testing Galileo Med35 in people with Hypermobility, Joint, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
Trial summary
The aim of this study was the assessment of muscle flexibility after 2-weeks of whole-body vibration (WBV) training in people with generalized joint hypermobility (GJH). The study included 33 participants aged 22-25 years. 12 participants were classified into the GJH group and 21 into the control group (CG). Read more about this study
- Who is it for?
- Ages 22 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypermobility, Joint
- What is being tested?
- Galileo Med35
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePoland
- Study dates
- 22 Aug 2022to 5 Sep 2022
- 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 22 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy young adults
Who cannot join
- rheumatological disease
- orthopaedic disease
- neurological disease
- genetic disease
- cardiovascular system disease
- previous injuries of lower limbs
Show all 12Show fewer
- surgeries of lower limbs and spine
- pain over 3 months of lower limbs and spine
- pregnancy
- implants
- the benign joint hypermobility syndrome (the Brighton criteria)
- the absence during one or more training day
Trial locations and contacts
1 site in 1 country.
Poland1 site
Gdansk University of Physical Education and Sport
Gdansk, Pomeranian Voivodeship, 80-336
About this study
The aim of this study was the assessment of muscle flexibility after 2-weeks of whole-body vibration (WBV) training in people with generalized joint hypermobility (GJH). The study included 33 participants aged 22-25 years. 12 participants were classified into the GJH group and 21 into the control group (CG). The study included the Beighton score and muscle flexibility tests: straight leg raise test (SLR), popliteal angle test (PA), and the modified Thomas test. These tests were performed before and after the short-term WBV program, which consisted of six sessions (frequency: 15 Hz and 30 Hz, amplitude 3 mm, 3 trials x 3 min.).
- Conditions
- Hypermobility, Joint
- Being tested
- Galileo Med35
- Medical subject headings
- Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galileo Med35Device
whole-body vibration training on the platform
| Study group | Role | What they receive |
|---|---|---|
| generalized joint hypermobility | Experimental | Not described Receives: Device: Galileo Med35 |
| without generalized joint hypermobility | Experimental | Not described Receives: Device: Galileo Med35 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beigthon score
The test consisted of the abduction of the thumb to the forearm, the knee hyperextension above 10 degrees, the extension of the metacarpophalangeal joint in the 5th finger above 90 degrees, the elbow hyperextension above 10 degrees, and the placing flat hands on the floor. Each positive test scored 1 point.
Measured: Before the main test of muscles flexibility and whole-body vibration training
Secondary outcomes (1)
Straight Leg Raise Test
The participant laid in a supine position. The researcher 1 controlled the position of the participant and raised their lower extremity with the knee extended to the first resistance of the hamstring. The researcher 2 assessed the range of hip flexion with an inclinometer, which was placed 10 cm proximally to the patella.
Measured: Twice - before and after 2-weeks of the whole-body vibration training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start22 Aug 2022
- Primary completion5 Sep 2022
- Study completion5 Sep 2022
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gdansk University of Physical Education and Sport
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paulina W Ewertowska, PhD, Study chair, Gdansk University of Physical Education and Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573880
- Sponsor's protocol ID
- AWFiS/2022_EP
- Status last verified
- Aug 2022
- First submitted
- 14 Sep 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Whole-body Vibration Training on Postural Stability in People With Generalized Joint Hypermobility
- ClinicalTrials.gov ID
- NCT05573880
- Acronym / sponsor ID
- AWFiS/2022_EP
- Conditions
- Hypermobility, Joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Gdansk University of Physical Education and SportUniversity, hospital or other
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 10 Oct 2022 (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.
The aim of this study was the assessment of muscle flexibility after 2-weeks of whole-body vibration (WBV) training in people with generalized joint hypermobility (GJH). The study included 33 participants aged 22-25 years. 12 participants were classified into the GJH group and 21 into the control group (CG). The study included the Beighton score and muscle flexibility tests: straight leg raise test (SLR), popliteal angle test (PA), and the modified Thomas test. These tests were performed before and after the short-term WBV program, which consisted of six sessions (frequency: 15 Hz and 30 Hz, amplitude 3 mm, 3 trials x 3 min.).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| generalized joint hypermobility | Experimental | Device: Galileo Med35 |
| without generalized joint hypermobility | Experimental | Device: Galileo Med35 |
Who may qualify
- Ages
- 22 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy young adults
Key exclusion criteria (12 listed)
- rheumatological disease
- orthopaedic disease
- neurological disease
- genetic disease
- cardiovascular system disease
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 |
|---|---|---|
| Galileo Med35whole-body vibration training on the platform | Device | generalized joint hypermobility, without generalized joint hypermobility |
Primary outcome
Beigthon score
Time frame: Before the main test of muscles flexibility and whole-body vibration training
The test consisted of the abduction of the thumb to the forearm, the knee hyperextension above 10 degrees, the extension of the metacarpophalangeal joint in the 5th finger above 90 degrees, the elbow hyperextension above 10 degrees, and the placing flat hands on the floor. Each positive test scored 1 point.
1 secondary outcome
Straight Leg Raise Test
Time frame: Twice - before and after 2-weeks of the whole-body vibration training
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 10 Oct 2022.
- 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.
Paulina W Ewertowska, PhD study chair
Gdansk University of Physical Education and Sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Galileo Med35 in people with Hypermobility, Joint, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
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 1 inclusion and 12 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 10 Oct 2022. 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 Poland. 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?
Beigthon score (time frame: Before the main test of muscles flexibility and whole-body vibration training). 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 10 Oct 2022.