- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05573880
The Influence of Whole-body Vibration Training on Postural Stability in People With Generalized Joint Hypermobility
October 7, 2022 updated by: Gdansk University of Physical Education and Sport
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 Overview
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pomorskie
-
Gdańsk, Pomorskie, Poland, 80-336
- Gdansk University of Physical Education and Sport
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy young adults
Exclusion Criteria:
- rheumatological disease
- orthopaedic disease
- neurological disease
- genetic disease
- cardiovascular system disease
- previous injuries of lower limbs
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: generalized joint hypermobility
|
whole-body vibration training on the platform
|
Experimental: without generalized joint hypermobility
|
whole-body vibration training on the platform
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Before the main test of muscles flexibility and whole-body vibration training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Straight Leg Raise Test
Time Frame: Twice - before and after 2-weeks of the whole-body vibration training
|
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.
|
Twice - before and after 2-weeks of the whole-body vibration training
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Popliteal Angle Test
Time Frame: Twice - before and after 2-weeks of the whole-body vibration training
|
The participant laid in a supine position with the hip flexed to 90˚ and the extended untested lower extremity.
The researcher 1 controlled this position with a goniometer.
In this position, the participant had to straighten his knee.
The researcher 2 assessed the popliteal angle with an inclinometer, which was placed 10 cm below the tibial tuberosity
|
Twice - before and after 2-weeks of the whole-body vibration training
|
Modified Thomas Test
Time Frame: Twice - before and after 2-weeks of the whole-body vibration training
|
The modified Thomas test was used to assess the flexibility of One-JHF and Two-JHF.
During One-JHF test, the participant laid in a supine position with the pelvis close to the edge of the table.
The untested lower extremity was flexed at the hip and knee joint.
The researcher 1 controlled and stabilized the participant's position.
The tested lower extremity was placed in a relaxed position behind the table.
The researcher 2 assessed the range of hip extension/flexion with the inclinometer, which was placed 10 cm proximally to the patella.
During the Two-JHF test, the participant was in the same position.
The researcher 1 assessed the range of knee flexion with the inclinometer, which was placed 10 cm below the tibial tuberosity
|
Twice - before and after 2-weeks of the whole-body vibration training
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Paulina W Ewertowska, PhD, Gdansk University of Physical Education and Sport
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 22, 2022
Primary Completion (Actual)
September 5, 2022
Study Completion (Actual)
September 5, 2022
Study Registration Dates
First Submitted
September 14, 2022
First Submitted That Met QC Criteria
October 7, 2022
First Posted (Actual)
October 10, 2022
Study Record Updates
Last Update Posted (Actual)
October 10, 2022
Last Update Submitted That Met QC Criteria
October 7, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AWFiS/2022_EP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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