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CompletedNCT03289689Updated Nov 28, 2017

Whole-body Vibration and Manual Ability

An interventional study of Whole-body vibration (WBV) in Body Weight, Vibration and Motor Activity, sponsored by Universidad Rey Juan Carlos. Completed at 1 site in Spain. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-28.

Sponsored by Universidad Rey Juan Carlos · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study summary

Purpose: To evaluate the short-term effects of whole-body vibration (WBV), using reciprocating plate technique, on manual ability performance in healthy younger.

Material and methods: 38 healthy young volunteers were randomized to WBV group (N=19; 6 men, 13 women; mean age 21, 3.8yrs) or control group (N=19; 6 men, 13 women; mean age 20.5, 3.5yrs). The subjects in the WBV group performed one series of five consecutive repetitions of 60 sec unsynchronised WBV (Zeptoring, Scisen GmbH, Germany; 4 Hz, amplitude 3mm) with a 1-min pause between administrations, three times a week. The controls did not receive any training. Both groups were evaluated at baseline and after intervention, in the Rey Juan Carlos University´s Gait Analysis Laboratory. Four outcome measures of Purdue Pegboard test (PPT): preferred hand (PH), non-preferred hand (NPH), both hands (BH) and assembly (A) was performed baseline and 5 min after intervention.

02

Conditions studied

  • Body Weight
  • Vibration
  • Motor Activity

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03

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy subjects aged between 18 and 30 years.

Exclusion criteria

Exclusion criteria:

  • Contraindication for WBV: pregnancy, recent fractures, malignancies, kidney stones, cardiac pacemaker, infectious disease or recent thromboembolic.
  • Subjects with any musculoskeletal o neurological disorders that affected their hands.
  • Individuals already treated with WBV were excluded.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Whole body vibration

    The subjects in the WBV group performed one series of five consecutive repetitions of 60 sec unsynchronised multidimensional WBV (Zeptoring, Scisen GmbH, Germany; 4 Hz, amplitude 3mm) with a 1-min pause between administrations, three times a week. The construction of this device is designed to perform a nonharmonious generation of oscillating movements in vertical and horizontal planes in order to prevent occurrences of resonance and habituation of receptors. During the intervention, subjects wore thin-soled gymnastic-type shoes, carrying out in a squatting standing position, with slight flexion at the hips, knees and ankle joint, on the vibration platform.

    Device: Whole-body vibration (WBV)

  • No intervention
    Control

    The controls did not receive any training.

Interventions

  • DeviceWhole-body vibration (WBV)

    Whole-body vibration (WBV) is a novel neuromuscular therapeutic intervention that has recently been developed since in the mid-1960s. Hagbart and Eklund showed in human experiments that a reflex muscle contraction can result as a consequence of applying vibrations to the muscular-tendon system. The subjects stand on a platform that generates stochastic vibrations at a frequency between 1-12.5 Hz.

05

What researchers measure

Primary outcomes

  1. Purdue Pegboard test (change)

    Change in Purdue Pegboard test. This tool evaluates the fine dexterity

    Time frame: Baseline, immediately after intervention and one month after the intervention

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Study locations

1 site
  • Universidad Rey Juan Carlos
    Alcorcón, Madrid 28922, Spain
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03289689
Lead sponsor
Universidad Rey Juan Carlos
Responsible party
Josue Fernandez Carnero (Principal Investigator, Universidad Rey Juan Carlos) — Principal investigator
First posted
Sep 21, 2017
Start date
Jul 1, 2017
Primary completion
Aug 31, 2017
Completion
Sep 10, 2017
Last update
Nov 28, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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