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Effects of Whole Body Vibration Training on Unstable Surface

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ClinicalTrials.gov Identifier: NCT02794194
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : June 9, 2016
Sponsor:
Information provided by (Responsible Party):
University of Castilla-La Mancha

Brief Summary:
After an initial ankle sprain, Chronic Ankle Instability is one of the most common residual symptoms which include pain, swelling, recurrent sprain, episodes of ankle joint "giving away" or decreased function. Recently, Whole Body Vibration (WBV) training has been introduced as a preventive and rehabilitative tool. It can be hypothesized that WBV on unstable surfaces might enhance neuromuscular control. Therefore, the aim of this study was to investigate the effects of a 6-week WBV training on an unstable surface on body composition, balance, strength and reflex and muscle activity of ankle muscles in recreational athletes with CAI.

Condition or disease Intervention/treatment Phase
Chronic Ankle Instability Other: Proprioceptive training on a whole body vibration platform Other: Proprioceptive training with the BOSU® on the floor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Whole Body Vibration Training on Unstable Surface in Recreational Athletes With Chronic Ankle Instability
Study Start Date : December 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
No Intervention: Control group
No intervention
Experimental: Vibration group
Proprioceptive training on a whole body vibration platform. Participants in the Vibration group trained with a BOSU® on a Fitvibe Excel Pro vibration platform (Fitvibe, Bilzen, Belgium).
Other: Proprioceptive training on a whole body vibration platform
The Training programme consisted of three series of 4 exercises of 45 seconds with 45 seconds rest between exercises. In this intervention participants trained with the BOSU® on a Fitvibe Excel Pro vibration platform (Fitvibe, Bilzen, Belgium).

Experimental: Non-vibration group
Proprioceptive training with the BOSU® on the floor. Participants in the Non-Vibration group trained with a BOSU® on the floor.
Other: Proprioceptive training with the BOSU® on the floor
The Training programme consisted of three series of 4 exercises of 45 seconds with 45 seconds rest between exercises. In this intervention participants trained with the BOSU® on the floor.




Primary Outcome Measures :
  1. Change in electromyographic activity [ Time Frame: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention ]
    Baseline: before the initiation of the exercise programs (at most 7 days before the initiation of the exercise programs). First follow-up measurement: after the completion of the exercise programs (at most 7 days after the completion of the last training session. Average time period: six weeks after the initiation of the intervention). Second follow-up measurement: 6 weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)

  2. Change in muscle strength [ Time Frame: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention ]
    Baseline: before the initiation of the exercise programs (at most 7 days before the initiation of the exercise programs). First follow-up measurement: after the completion of the exercise programs (at most 7 days after the completion of the last training session. Average time period: six weeks after the initiation of the intervention). Second follow-up measurement: 6 weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)

  3. Change in balance (Biodex Balance System test) [ Time Frame: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention ]
    Baseline: before the initiation of the exercise programs (at most 7 days before the initiation of the exercise programs). First follow-up measurement: after the completion of the exercise programs (at most 7 days after the completion of the last training session. Average time period: six weeks after the initiation of the intervention). Second follow-up measurement: 6 weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)

  4. Change in balance (Star Excursion Balance Test (SEBT) [ Time Frame: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention ]
    Baseline: before the initiation of the exercise programs (at most 7 days before the initiation of the exercise programs). First follow-up measurement: after the completion of the exercise programs (at most 7 days after the completion of the last training session. Average time period: six weeks after the initiation of the intervention). Second follow-up measurement: 6 weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)


Secondary Outcome Measures :
  1. Change in lean mass and fat mass (obtained using the enCORE software (GE Healthcare, v. 13.40) [ Time Frame: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention ]
    Baseline: before the initiation of the exercise programs (at most 7 days before the initiation of the exercise programs). First follow-up measurement: after the completion of the exercise programs (at most 7 days after the completion of the last training session. Average time period: six weeks after the initiation of the intervention). Second follow-up measurement: 6 weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)

  2. Change in bone mineral content and bone mineral density (obtained using the enCORE software (GE Healthcare, v. 13.40) [ Time Frame: baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention ]
    Baseline: before the initiation of the exercise programs (at most 7 days before the initiation of the exercise programs). First follow-up measurement: after the completion of the exercise programs (at most 7 days after the completion of the last training session. Average time period: six weeks after the initiation of the intervention). Second follow-up measurement: 6 weeks after the completion of the exercise programs (average time period: twelve weeks after the initiation of the intervention)



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of at least 1 significant ankle sprain (the most recent injury must have occurred more than 3 months prior to study enrolment).
  • 2 or more episodes of the ankle giving way in the last 6 months.
  • A score of ≤24 on the Spanish version of the Cumberland Ankle Instability Tool.
  • Age range: 18-30 years.

Exclusion Criteria:

  • History of previous surgeries to the musculoskeletal structures in either lower extremity.
  • History of a fracture in either lower extremity requiring realignment.
  • An acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months that impacted joint integrity and function, resulting in at least 1 interrupted day of desired physical activity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794194


Locations
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Spain
Performance and Sport Rehabilitation Laboratory
Toledo, Spain, 45071
Sponsors and Collaborators
University of Castilla-La Mancha
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Castilla-La Mancha
ClinicalTrials.gov Identifier: NCT02794194    
Other Study ID Numbers: LRRD2016/001
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016
Keywords provided by University of Castilla-La Mancha:
Chronic Ankle Instability
Whole Body Vibration
Proprioception