NCT05573880

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.).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2022

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
Last Updated

October 10, 2022

Status Verified

August 1, 2022

Enrollment Period

14 days

First QC Date

September 14, 2022

Last Update Submit

October 7, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Before the main test of muscles flexibility and whole-body vibration training

Secondary Outcomes (1)

  • Straight Leg Raise Test

    Twice - before and after 2-weeks of the whole-body vibration training

Other Outcomes (2)

  • Popliteal Angle Test

    Twice - before and after 2-weeks of the whole-body vibration training

  • Modified Thomas Test

    Twice - before and after 2-weeks of the whole-body vibration training

Study Arms (2)

generalized joint hypermobility

EXPERIMENTAL
Device: Galileo Med35

without generalized joint hypermobility

EXPERIMENTAL
Device: Galileo Med35

Interventions

whole-body vibration training on the platform

generalized joint hypermobilitywithout generalized joint hypermobility

Eligibility Criteria

Age22 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy young adults

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gdansk University of Physical Education and Sport

Gdansk, Pomeranian Voivodeship, 80-336, Poland

Location

MeSH Terms

Conditions

Joint Instability

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Paulina W Ewertowska, PhD

    Gdansk University of Physical Education and Sport

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2022

First Posted

October 10, 2022

Study Start

August 22, 2022

Primary Completion

September 5, 2022

Study Completion

September 5, 2022

Last Updated

October 10, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations