Proprioceptive DisordersNCT02804685
Effectiveness of an Exercise Protocol on Alteration of Knee Joint Position Sense in Futsal Players
A study testing exercise protocol in people with Proprioceptive Disorders and Knee Injuries, run by University of Alcala at 1 site in Spain.
Trial summary
This research presents a randomized clinical trial which evaluates the effectiveness of an exercise protocol on the knee-joint repositioning in futsal players related to a post-match muscle fatigue. Read more about this study
- Who is it for?
- Ages 16 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Proprioceptive Disorders, Knee Injuries, Athletic Injuries
- What is being tested?
- exercise protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2016to Oct 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 16 to 24 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Must have three years of experience in futsal Must be Licensed players
Who cannot join
- lower limb injuries
Trial locations and contacts
1 site in 1 country.
About this study
This research presents a randomized clinical trial which evaluates the effectiveness of an exercise protocol on the knee-joint repositioning in futsal players related to a post-match muscle fatigue. Our hypothesis is the improvement of sensation in a knee in joint position before and after the match when performing our exercise program.
- Conditions
- Proprioceptive Disorders, Knee Injuries, Athletic Injuries
- Being tested
- exercise protocol
- Medical subject headings
- Somatosensory Disorders, Knee Injuries, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise protocolOther
The multi-intervention exercise protocol consists in a performance of agility, strength and balance exercises. It has to be fulfilled during 6 weeks (twice a week) before the regular training performance. The exercises should be done for almost 15 minutes approx. There will be 6 exercises in total: squat with toe raise, one-leg squats, single-leg balance (throwing a ball with a partner), vertical jumps, hamstring exercise, quick forwards and backwards sprints.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | It consists on only a regular training performance |
| Experimental | Experimental | It consists on performing the protocol which includes 6 strength, agility and balance exercises together with the regular training. The exercise program has to be performed twice a week during 6 weeks Receives: Other: exercise protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint Position Sense
Joint Position Sense: Pictures of the knee joint repositioning of the participant are taken. The camera is placed perpendicularly 2 m from the knee joint and 65 cm from the ground. As references, 4 markers are placed in the lower extremity. The participant is seated with his feet dangling and his eyes closed. The dominant leg of the participant is passively carried by the examiner to 45 ° knee flexion. The participant is asked to maintain that position for 10 seconds. After that examiner returns the leg of the player to initial position in a passive way. The participant is then asked to change the position of the leg in an active way to the target position and maintain it for 4 seconds. After that he should return to the initial position. This exercise should be done 3 times. In each position a photograph is taken and then all of them are measured by Autocad which specifies the angles. The absolute angular error, the relative angular error and the variable angular error are measured.
Measured: up to 6 weeks after the end of the intervention
Secondary outcomes (2)
Vertical jump heigh
Vertical jump height: for this, computer software "HSC-Kinovea" must be used. To perform the jump, hands should be placed on hips and the maximum impulse should be taken with both legs in order to take off from the ground. Each participant performs 5 preparatory jumps and then another 5 jumps (as high as possible). These 5 last jumps are the ones that will be analyzed. The height of the best jump is obtained through the formula mentioned above.
The flight time of these 5 jumps will be recorded with a camera that films 240 frames per second (Canon PowerShot SX700 HS). The analysis of the data is done with the software "Kinovea 0.8.15 for Windows" that measures the time difference between the first frame in which both feet are taking off the floor and the frame in which only one or both feet land. This measurement allows us to relate the height of each jump with muscle fatigue
Measured: up to 6 weeks after the end of the intervention
Perceived exertion rate
Perceived exertion rate is obtained through the Borg Scale for Perceived Exertion (Borg's 6 to 10 Rating of Perceived Exertion Scale) with the aim of relating the subjective perception of the effort with objective measures of muscle fatigue. It is a discrete quantitative variable.
Borg Scale for Perceived Exertion will be given to the participants at the end of each match. It consists of a list of numbers from 6 to 20 which are related to subjective expressions of effort (no effort: 6, extremely light: 7-8, very light: 9, light 11 moderate: 13, hard 15, very hard 17, extremely hard: 19, maximum effort: 20). The participant will be asked how they felt during this physical activity (in relation with the effort). The collected data will be related to the numeric value.
Measured: up to 6 weeks after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proprioceptive DisordersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Fabián Gómez Chiguano, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804685
- Sponsor's protocol ID
- DAG Research Group
- Status last verified
- Oct 2016
- First submitted
- 8 Jun 2016
- Last updated
- 27 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Exercise Protocol on Alteration of Knee Joint Position Sense in Futsal Players
- ClinicalTrials.gov ID
- NCT02804685
- Acronym / sponsor ID
- DAG Research Group
- Conditions
- Proprioceptive Disorders, Knee Injuries, Athletic Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 17 Jun 2016 (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.
This research presents a randomized clinical trial which evaluates the effectiveness of an exercise protocol on the knee-joint repositioning in futsal players related to a post-match muscle fatigue. Our hypothesis is the improvement of sensation in a knee in joint position before and after the match when performing our exercise program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –It consists on only a regular training performance |
| Experimental | Experimental | Other: exercise protocolIt consists on performing the protocol which includes 6 strength, agility and balance exercises together with the regular training. The exercise program has to be performed twice a week during 6 weeks |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Must have three years of experience in futsal Must be Licensed players
Key exclusion criteria (1 listed)
- lower limb injuries
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 |
|---|---|---|
| exercise protocolThe multi-intervention exercise protocol consists in a performance of agility, strength and balance exercises. It has to be fulfilled during 6 weeks (twice a week) before the regular training performance. The exercises should be done for almost 15 minutes approx. There will be 6 exercises in total: squat with toe raise, one-leg squats, single-leg balance (throwing a ball with a partner), vertical jumps, hamstring exercise, quick forwards and backwards sprints. | Other | Experimental |
Primary outcome
Joint Position Sense
Time frame: up to 6 weeks after the end of the intervention
Joint Position Sense: Pictures of the knee joint repositioning of the participant are taken. The camera is placed perpendicularly 2 m from the knee joint and 65 cm from the ground. As references, 4 markers are placed in the lower extremity. The participant is seated with his feet dangling and his eyes closed. The dominant leg of the participant is passively carried by the examiner to 45 ° knee flexion. The participant is asked to maintain that position for 10 seconds. After that examiner returns the leg of the player to initial position in a passive way. The participant is then asked to change the position of the leg in an active way to the target position and maintain it for 4 seconds. After that he should return to the initial position. This exercise should be done 3 times. In each position a photograph is taken and then all of them are measured by Autocad which specifies the angles. The absolute angular error, the relative angular error and the variable angular error are measured.
2 secondary outcomes
Vertical jump heigh
Time frame: up to 6 weeks after the end of the intervention
Perceived exertion rate
Time frame: up to 6 weeks after the end of the intervention
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 27 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise protocol in people with Proprioceptive Disorders and Knee Injuries, run by University of Alcala at 1 site in Spain.
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 1 inclusion and 1 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 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Joint Position Sense (time frame: up to 6 weeks after the end of the intervention). 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 27 Oct 2016; AzTrials last refreshed its copy on 6 Nov 2026.