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Whole-body Vibration and Manual Ability

Primary Purpose

Body Weight, Vibration, Motor Activity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Whole-body vibration (WBV)
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Weight

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

- Healthy subjects aged between 18 and 30 years.

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.

Sites / Locations

  • Universidad Rey Juan Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Whole body vibration

Control

Arm Description

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.

The controls did not receive any training.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 13, 2017
Last Updated
November 26, 2017
Sponsor
Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT03289689
Brief Title
Whole-body Vibration and Manual Ability
Official Title
The Acute Effects of Whole-Body Vibration on Manual Ability Performance: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
September 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight, Vibration, Motor Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Whole body vibration
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The controls did not receive any training.
Intervention Type
Device
Intervention Name(s)
Whole-body vibration (WBV)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Purdue Pegboard test (change)
Description
Change in Purdue Pegboard test. This tool evaluates the fine dexterity
Time Frame
Baseline, immediately after intervention and one month after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: - Healthy subjects aged between 18 and 30 years. 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.
Facility Information:
Facility Name
Universidad Rey Juan Carlos
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Whole-body Vibration and Manual Ability

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