NCT02794194

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

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

December 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 9, 2016

Completed
Last Updated

June 9, 2016

Status Verified

June 1, 2016

Enrollment Period

4 months

First QC Date

May 27, 2016

Last Update Submit

June 8, 2016

Conditions

Keywords

Chronic Ankle InstabilityWhole Body VibrationProprioception

Outcome Measures

Primary Outcomes (4)

  • Change in electromyographic activity

    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)

    baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention

  • Change in muscle strength

    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)

    baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention

  • Change in balance (Biodex Balance System test)

    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)

    baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention

  • Change in balance (Star Excursion Balance Test (SEBT)

    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)

    baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention

Secondary Outcomes (2)

  • Change in lean mass and fat mass (obtained using the enCORE software (GE Healthcare, v. 13.40)

    baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention

  • Change in bone mineral content and bone mineral density (obtained using the enCORE software (GE Healthcare, v. 13.40)

    baseline, after the completion of the intervention, and 6 weeks after the completion of the intervention

Study Arms (3)

Control group

NO INTERVENTION

No intervention

Vibration group

EXPERIMENTAL

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

Non-vibration group

EXPERIMENTAL

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

Interventions

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).

Vibration group

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.

Non-vibration group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • History of at least 1 significant ankle sprain (the most recent injury must have occurred more than 3 months prior to study enrolment).
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Performance and Sport Rehabilitation Laboratory

Toledo, Toledo, 45071, Spain

Location

Related Publications (1)

  • Sierra-Guzman R, Jimenez JF, Ramirez C, Esteban P, Abian-Vicen J. Effects of Synchronous Whole Body Vibration Training on a Soft, Unstable Surface in Athletes with Chronic Ankle Instability. Int J Sports Med. 2017 Jun;38(6):447-455. doi: 10.1055/s-0043-102571. Epub 2017 May 9.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2016

First Posted

June 9, 2016

Study Start

December 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

June 9, 2016

Record last verified: 2016-06

Locations