NCT02609971

Brief Summary

The purpose of this study is to analyze the immediate effects of two exercises protocols on the whole body vibration, on the strength of the thigh muscles, joint position sense of the knee and balance in individuals submitted to anterior cruciate ligament reconstruction.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

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

February 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

Enrollment Period

11 months

First QC Date

November 16, 2015

Last Update Submit

July 14, 2016

Conditions

Keywords

Anterior cruciate ligamentNeuromuscular Performance and balance

Outcome Measures

Primary Outcomes (1)

  • Muscle Performance measured through isokinetic dynamometer

    Measured through isokinetic dynamometer. The variable analyzed will be: peak torque normalized by body weight (%).

    Change from baseline in muscle performance at one hour.

Secondary Outcomes (1)

  • Muscle activation measured through surface electromyography

    Change from baseline in electromyographic activity at one hour.

Study Arms (2)

Vibration group

EXPERIMENTAL

The vibration group (Vibration at 50 Hz) will hold an exercise protocol on the vibration platform (model Power Plate® pro5 ™), which is to stay on on affected limb, with the knee held in 40 ° of flexion, hands together to the body and the trunk in the erect position. Altogether, the participant will perform 11 sets of 30 seconds with a rest interval of 30 seconds between sets. The knee angle will be monitored throughout the protocol by the second reviewer with a goniometer so that there is no change in it. During the sets the vibrating platform will be turned on at a vibration frequency of 50 Hz.

Other: Vibration at 50 Hz

Control group

NO INTERVENTION

The control group (No vibration) will hold an exercise protocol on the vibration platform, which is to stay on affected limb, with the knee held in 40 ° of flexion, hands together to the body and the trunk in the erect position. Altogether, the participant will perform 11 sets of 30 seconds with a rest interval of 30 seconds between sets. The knee angle will be monitored throughout the protocol by the second reviewer with a goniometer so that there is no change in it. The vibrating platform will remain off throughout intervention.

Interventions

During the exercise protocol, the vibration platform will be turned on at a vibration frequency of 50 Hz.

Vibration group

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects between the 14th and 18th postoperatory week;
  • Without pain or inflammatory signs in the joint assessed;
  • Absence of labyrinthine and neurological disorders;
  • Range of motion greater than 90o flexion and complete extension;
  • No previous history of lower limb surgery before the lesion;
  • Be performing Physical Therapy

You may not qualify if:

  • Inability to understand and/or perform the required maneuvers;
  • Presence of pain at the time of the tests;
  • Complication preventing collection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Physiotherapy

Study Record Dates

First Submitted

November 16, 2015

First Posted

November 20, 2015

Study Start

February 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

July 18, 2016

Record last verified: 2016-07