The Influence of Whole-body Vibration Training on Postural Stability in People With Generalized Joint Hypermobility
Primary Purpose
Hypermobility, Joint
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Galileo Med35
Sponsored by
About this trial
This is an interventional supportive care trial for Hypermobility, Joint
Eligibility Criteria
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
Sites / Locations
- Gdansk University of Physical Education and Sport
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
generalized joint hypermobility
without generalized joint hypermobility
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05573880
First Posted
September 14, 2022
Last Updated
October 7, 2022
Sponsor
Gdansk University of Physical Education and Sport
1. Study Identification
Unique Protocol Identification Number
NCT05573880
Brief Title
The Influence of Whole-body Vibration Training on Postural Stability in People With Generalized Joint Hypermobility
Official Title
The Influence of Whole-body Vibration Training on Postural Stability in People With Generalized Joint Hypermobility
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
September 5, 2022 (Actual)
Study Completion Date
September 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gdansk University of Physical Education and Sport
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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). 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.).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypermobility, Joint
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
generalized joint hypermobility
Arm Type
Experimental
Arm Title
without generalized joint hypermobility
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Galileo Med35
Intervention Description
whole-body vibration training on the platform
Primary Outcome Measure Information:
Title
Beigthon score
Description
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.
Time Frame
Before the main test of muscles flexibility and whole-body vibration training
Secondary Outcome Measure Information:
Title
Straight Leg Raise Test
Description
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.
Time Frame
Twice - before and after 2-weeks of the whole-body vibration training
Other Pre-specified Outcome Measures:
Title
Popliteal Angle Test
Description
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
Time Frame
Twice - before and after 2-weeks of the whole-body vibration training
Title
Modified Thomas Test
Description
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
Time Frame
Twice - before and after 2-weeks of the whole-body vibration training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulina W Ewertowska, PhD
Organizational Affiliation
Gdansk University of Physical Education and Sport
Official's Role
Study Chair
Facility Information:
Facility Name
Gdansk University of Physical Education and Sport
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-336
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
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The Influence of Whole-body Vibration Training on Postural Stability in People With Generalized Joint Hypermobility
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