Anterior Cruciate Ligament ReconstructionNCT02609971
Whole Body Vibration in Individuals Submitted to ACL
A study testing Vibration at 50 Hz in people with Anterior Cruciate Ligament Reconstruction, run by Universidade Federal do Rio Grande do Norte.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Vibration at 50 Hz
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Inability to understand and/or perform the required maneuvers;
- Presence of pain at the time of the tests;
- Complication preventing collection.
About this study
Official title: Immediate Effects of Whole Body Vibration on Neuromuscular Performance of Quadriceps Femoris in Individuals Submitted to Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial
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.
Read the detailed description
This is a randomized and blinded clinical trial held at the Laboratory of Neuromuscular Performance of the Department of Physical Therapy, Federal University of Rio Grande do Norte (UFRN). Characterization of the sample: The sample consisted of 46 men submitted to anterior cruciate ligament reconstruction. The participants were randomly divided into 2 distinct groups. Ethical aspects: For its implementation, this project was submitted to the Research Ethics Committee (REC) of the Federal University of Rio Grande do Norte. Was respected and ensured the autonomy and anonymity of participants, as well as privacy as confidential data, as governed Resolution 196/96 of the National Health Council and the Helsinki declaration for human research. Instruments: Stationary bicycle (Ergo-Fit, ErgoCycle 167, Pirmasens, Germany); computerized baropodometry platform Eclipse 3000 model (Guy-Capron® SA, France); vibrating platform model Power Plate® pro5 ™; signal conditioning module (Telemyo direct transmission system) 8-channel (Noraxon, USA); self-adhesive electrode active surface (Noraxon, USA); isokinetic dynamometer (Biodex Multi-Joint System 4, Biomedical Biodex System Inc.®, New York, USA). Procedures: There was a previous pilot study for adequacy of any research procedures and the training of evaluators. The volunteers were informed about the procedures to be performed in the research, signed the informed consent form, fill in an evaluation form with anthropometric data and personal examination of members. Evaluations were performed before and after the intervention protocol. Initially, all the volunteers executed a warming exercise on a stationary bike for 5 minutes. After that, they were submitted for shaving and cleaning the skin with 70% alcohol before attaching the electrodes on vastus medialis and vastus lateralis. Torque rating: the volunteer was positioned sitting on the dynamometer, stabilized by braces and with the device axis aligned with the knee evaluated. The apparatus of the lever arm was attached to the distal leg. Then, it was performed the normalization of the electromyographic signal, where the subject performed two maximal voluntary isometric contractions of knee extension at an angle of 60 ° for 5s, with one-minute interval between each repetition. After, the concentric evaluation was conducted, with 5 maximal contractions for knee flexion and extension at 60 ° / s, starting from 90 ° flexion up to full extension. Joint position sense: The volunteer was instructed to perform a knee extension member starting with 90 ° of flexion. When the 45 target angle wass reached, the dynamometer arm remained in this position, keeping it for 5 seconds, so that the voluntary noticed which the angle to be achieved. Finally, prompted an active extension from 90 ° knee flexion (1 / s) to the target angle, the second trial of the subject. At that moment, the volunteer should trigger a device to record the angle reached. Postural balance: the volunteers were placed standing on the baropodometry platform, supported in the non-dominant member and with the knee kept at 40 ° of flexion. The affected limb remained with the knee in 90 ° of flexion. The evaluation was repeated 3 times, being considered for analysis the average of the two best measures. The evaluation time was 20 seconds on an acquisition frequency of 20 Hz with a period of 1 minute break between tests. Previously the participant was allowed to become familiar with the equipment. Electromyographic activity: emg was collected concurrently with exercise protocols on the platform, as well as during the torque rating.
- Being tested
- Vibration at 50 Hz
- Keywords
- Anterior cruciate ligament, Neuromuscular Performance and balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration at 50 HzOther
During the exercise protocol, the vibration platform will be turned on at a vibration frequency of 50 Hz.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Performance measured through isokinetic dynamometer
Measured through isokinetic dynamometer. The variable analyzed will be: peak torque normalized by body weight (%).
Measured: Change from baseline in muscle performance at one hour.
Secondary outcomes (1)
Muscle activation measured through surface electromyography
Measured by surface electromyography. The variable analyzed will be: RMS (Root Mean Square.
Measured: Change from baseline in electromyographic activity at one hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609971
- Sponsor's protocol ID
- 07042915KA
- Status last verified
- Jul 2016
- First submitted
- 16 Nov 2015
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Whole Body Vibration on Neuromuscular Performance of Quadriceps Femoris in Individuals Submitted to Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02609971
- Acronym / sponsor ID
- 07042915KA
- Keywords
- Anterior cruciate ligament, Neuromuscular Performance and balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized and blinded clinical trial held at the Laboratory of Neuromuscular Performance of the Department of Physical Therapy, Federal University of Rio Grande do Norte (UFRN). Characterization of the sample: The sample consisted of 46 men submitted to anterior cruciate ligament reconstruction. The participants were randomly divided into 2 distinct groups. Ethical aspects: For its implementation, this project was submitted to the Research Ethics Committee (REC) of the Federal University of Rio Grande do Norte. Was respected and ensured the autonomy and anonymity of participants, as well as privacy as confidential data, as governed Resolution 196/96 of the National Health Council and the Helsinki declaration for human research. Instruments: Stationary bicycle (Ergo-Fit, ErgoCycle 167, Pirmasens, Germany); computerized baropodometry platform Eclipse 3000 model (Guy-Capron® SA, France); vibrating platform model Power Plate® pro5 ™; signal conditioning module (Telemyo direct transmission system) 8-channel (Noraxon, USA); self-adhesive electrode active surface (Noraxon, USA); isokinetic dynamometer (Biodex Multi-Joint System 4, Biomedical Biodex System Inc.®, New York, USA). Procedures: There was a previous pilot study for adequacy of any research procedures and the training of evaluators. The volunteers were informed about the procedures to be performed in the research, signed the informed consent form, fill in an evaluation form with anthropometric data and personal examination of members. Evaluations were performed before and after the intervention protocol. Initially, all the volunteers executed a warming exercise on a stationary bike for 5 minutes. After that, they were submitted for shaving and cleaning the skin with 70% alcohol before attaching the electrodes on vastus medialis and vastus lateralis. Torque rating: the volunteer was positioned sitting on the dynamometer, stabilized by braces and with the device axis aligned with the knee evaluated. The apparatus of the lever arm was attached to the distal leg. Then, it was performed the normalization of the electromyographic signal, where the subject performed two maximal voluntary isometric contractions of knee extension at an angle of 60 ° for 5s, with one-minute interval between each repetition. After, the concentric evaluation was conducted, with 5 maximal contractions for knee flexion and extension at 60 ° / s, starting from 90 ° flexion up to full extension. Joint position sense: The volunteer was instructed to perform a knee extension member starting with 90 ° of flexion. When the 45 target angle wass reached, the dynamometer arm remained in this position, keeping it for 5 seconds, so that the voluntary noticed which the angle to be achieved. Finally, prompted an active extension from 90 ° knee flexion (1 / s) to the target angle, the second trial of the subject. At that moment, the volunteer should trigger a device to record the angle reached. Postural balance: the volunteers were placed standing on the baropodometry platform, supported in the non-dominant member and with the knee kept at 40 ° of flexion. The affected limb remained with the knee in 90 ° of flexion. The evaluation was repeated 3 times, being considered for analysis the average of the two best measures. The evaluation time was 20 seconds on an acquisition frequency of 20 Hz with a period of 1 minute break between tests. Previously the participant was allowed to become familiar with the equipment. Electromyographic activity: emg was collected concurrently with exercise protocols on the platform, as well as during the torque rating.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibration group | Experimental | Other: Vibration at 50 HzThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- Inability to understand and/or perform the required maneuvers;
- Presence of pain at the time of the tests;
- Complication preventing collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibration at 50 HzDuring the exercise protocol, the vibration platform will be turned on at a vibration frequency of 50 Hz. | Other | Vibration group |
Primary outcome
Muscle Performance measured through isokinetic dynamometer
Time frame: Change from baseline in muscle performance at one hour.
Measured through isokinetic dynamometer. The variable analyzed will be: peak torque normalized by body weight (%).
1 secondary outcome
Muscle activation measured through surface electromyography
Time frame: Change from baseline in electromyographic activity at one hour.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Vibration at 50 Hz in people with Anterior Cruciate Ligament Reconstruction, run by Universidade Federal do Rio Grande do Norte.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Performance measured through isokinetic dynamometer (time frame: Change from baseline in muscle performance at one hour.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2016.