Balance Instability TrainingNCT06472648
Effects of an Instability Training Program Using Global Versus Selective Instability Devices
A study testing Proprioception training exercise plan with BOSU and Proprioception training exercise plan with Blackboard (BB) in people with Balance Instability Training, run by University of Valencia at 1 site in Spain.
Trial summary
The goal of this clinical trial was to compare the effects of a 4-week balance training programme using a GID or SID on functional dynamic balance and functional ankle stability in young healthy amateur soccer players. The main question it aimed to answer are: 1. Read more about this study
- Who is it for?
- Ages 16 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance Instability Training
- What is being tested?
- Proprioception training exercise plan with BOSU and Proprioception training exercise plan with Blackboard (BB)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 18 Nov 2019to 21 Feb 2020
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- No lower limb surgery during the last year prior to participation
- No history of pain in either ankles, knees or hips during the two months prior to participation
- Not having sprained either ankle for at least three months prior to participation
Who cannot join
- Had participated in lower limb balance and proprioception programmes or had suffered balance alterations such as vertigo, vestibular or central disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Instability Training Program Using Global Versus Selective Instability Devices on Dynamic Balance and Ankle Stability in Young Amateur Soccer Players
The goal of this clinical trial was to compare the effects of a 4-week balance training programme using a GID or SID on functional dynamic balance and functional ankle stability in young healthy amateur soccer players.
The main question it aimed to answer are:
Read more
- Are there differences between using GID or SID in improving dynamic balance according to the Modified Star Excursion Balance Test (mSEBT) and the Emery test, and in improving functional ankle stability according to the Side Hop Test?
Participants were randomly allocated into two groups: GID balance training (i.e., with a BOSU®) and SID balance training (i.e., with Blackboard). The randomization and allocation were performed using the sealed envelope method. Both groups performed on a 4-weeks balance training program with the assigned device.
Participants were asked to:
- Perform a 5-minute conventional warm-up (cycling and active anke mobility exercises)
- Perform four balance exercises with a 3-kg medicine ball, on the unstable surface device assigned to each group (explanation of the exercises in the detailed description)
Researchers compared the results of the GID group with those of the SID group to determine the differences between devices in the improvement of dynamic balance and functional stability of the foot and ankle.
Read the detailed description
Sport injuries are one of the main concerns of soccer players and their coaching staff and ankle sprains are one of the most common injuries in this sport. Sprains have a high recurrence in soccer, leading to pathological laxity, residual pain, and sensorimotor deficits in the ankle which could cause stability alterations known as chronic ankle instability. In this sense, numerous efforts have been made to find alternatives to reduce the incidence and recurrence of ankle sprains, but the exercise protocols designed to date are still not completely effective. Therefore, studies that deal with exercises or devices that could produce changes in ankle stability and, consequently, can reduce injury rates, are still necessary.
Stability training programmes are generally performed on unstable surfaces such as Both Sides Utilized (BOSU®), balance boards, pads, soft mats, air cushions, or tilting platforms. These tools are generally considered global instability devices (GIDs) as the direction and intensity of the instability cannot be selected and adjusted by the user. Although not yet widely studied, a new device designed to overcome these limitations is the Blackboard Training, as selective instability device (SID). In a previous study, the investigators compared muscle activation of the peroneus longus during single-leg stance on the Blackboard Training and on other GIDs (including BOSU®), finding no differences between devices. These findings may suggest that the use of the SID to improve functional ankle balance in athlete's ankle sprain preventive programs could be effective, at least, as those produced by GID, but a clinical comparison has not yet been conducted.
Thus, the aim of this study was to compare the effects of a 4-week balance training programme using a GID or SID on functional dynamic balance and functional ankle stability in young healthy amateur soccer players.
A total number of 20 amateur soccer players were randomly allocated into two groups (GID and SID). Sociodemographic, anthropometric, dynamic balance (modified Star Excursion Balance Test and Emery Test) and ankle stability (Side Hop Test) data were collected.
After a 5-minute warm up, participants performed the same exercises on their assigned device (BOSU in its inverted position for the GID group, or Blackboard with the two slats placed centrally for the SID group), which was a modified version of a previously proposed plan for proprioception training in athletes. The exercises were the same for both groups and were performed with a 3-kg medicine ball, being the only difference the unstable surface device. These were the following:
- A 30-second series of maintaining the single-leg stance position with extended knee and hip holding the ball with the arms stretched out above the head; the free leg was kept at 90º hip and knee flexion.
- A series of 10 repetitions where the participant was asked to pass from the supporting-leg hip and knee starting position to a 90º knee flexion squat, keeping the ball above their heads and maintaining the other leg with the knee and hip about 90º flexed.
- A single series of 10 repetitions where the participant started with full limb extension of the supporting member and the ball held with both hands at chest height; from this position subjects were asked to bring the free leg from 45º hip extension to 45º hip flexion.
- 10 passes between the participant and a partner where the participants started with a total extension of the supporting limb and the ball held in both hands in front of them at chest height, and their free leg flexed 90º at the hip and the knee. A 2-minute rest between exercises was allowed.
The stability training programme was performed for a period of 4 weeks, with 3 weekly sessions using BOSU® or Blackboard at their soccer club before their usual training and under the supervision of a physical therapist. In all, 12 sessions were completed.
- Conditions
- Balance Instability Training
- Being tested
- Proprioception training exercise plan with BOSU, Proprioception training exercise plan with Blackboard (BB)
- Keywords
- Instability device, Amateur soccer players
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioception training exercise plan with BOSUOther
A 5' conventional warm-up (stationary cycling and active ankle mobility exercises) was performed.
Ankle proprioception training exercise plan included:
- A 30-second series of maintaining the single-leg stance position on the BOSU with extended knee and hip holding the ball with the arms stretched out above the head
- A series of 10 reps on the BOSU where the subject was asked to pass from the supporting-leg hip and knee starting position to a 90º knee flexion squat, keeping the ball above their heads
- A single series of 10 reps on the BOSU where the subject started with full limb extension of the supporting member and the ball held with both hands at chest height; from this position subjects were asked to bring the free leg from 45º hip extension to 45º hip flexion
- 10 passes between the subject and a partner where the participants started with a total extension of the supporting limb on the BOSU and the ball held in both hands in front of them.
2' rest between exercises.
Proprioception training exercise plan with Blackboard (BB)Other
A 5' conventional warm-up (stationary cycling and active ankle mobility exercises) was performed.
Ankle proprioception training exercise plan included:
- A 30-second series of maintaining the single-leg stance position on the BB with extended knee and hip holding the ball with the arms stretched out above the head
- A series of 10 reps on the BB where the subject was asked to pass from the supporting-leg hip and knee starting position to a 90º knee flexion squat, keeping the ball above their heads
- A single series of 10 reps on the BB where the subject started with full limb extension of the supporting member and the ball held with both hands at chest height; from this position subjects were asked to bring the free leg from 45º hip extension to 45º hip flexion
- 10 passes between the subject and a partner where the participants started with a total extension of the supporting limb on the BB and the ball held in both hands in front of them.
2' rest between exercises.
| Study group | Role | What they receive |
|---|---|---|
| GID group | Experimental | GID: Global Instability Device. Out of the total sample, 10 subjects were randomly assigned to each group. The GID group consisted of 10 amateur soccer players, both men and women, who performed the intervention using the BOSU. Receives: Other: Proprioception training exercise plan with BOSU |
| SID group | Experimental | SID: Specific Instability Device. Out of the total sample, 10 subjects were randomly assigned to each group. The SID group consisted of 10 amateur soccer players, both men and women, who performed the intervention using the Blackboard. Receives: Other: Proprioception training exercise plan with Blackboard (BB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Balance (mSEBT)
Firstly, for assessing dynamic balance, the three-directions modified Star Excursion Balance Test (mSEBT) and Emery Test were employed.
The mSEBT consists of standing on one leg while reaching with the contralateral leg the farthest possible point in three different directions (anterior, posteromedial, and posterolateral). The distance reached in each attempt was normalised with the leg length. Each participant was allowed to make two attempts with each leg and in each direction to practice. Then, three more attempts were performed. A 15-second rest time was allowed between attempts of the same position, and five minutes between the different directions. All measurements were made barefoot and with hands placed on hips. The mSEBT has demonstrated excellent inter- and intra-rater reliability.
Measured: Pre and after 4 weeks of intervention
Dynamic Balance (Emery Test )
For the Emery Test, subjects should maintain single-leg stance on an Airex® Balance Pad, with their eyes closed, barefoot, and with their hands placed on their hips. The subjects were asked to remain as stable as possible for a maximum time of 180 seconds.
Three attempts were performed with 15-second rests and the best time obtained for each leg was registered. Before starting the measurements, the subjects were allowed to become familiarised with the test for 15 seconds.
Measured: Pre and after 4 weeks of intervention
Ankle stability (Side Hop Test)
The test consists of jumping laterally on one leg 30 cm delimited by two lines marked on the ground. Participants performed 10 repetitions barefoot (a total of 20 jumps) in the shortest possible time. Each participant made three attempts with each leg, with 1-minute rests. The best time for each leg was registered. One repetition was allowed before starting for practice.
Measured: Pre and after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start18 Nov 2019
- Primary completion21 Feb 2020
- Study completion21 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance Instability TrainingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Martín-San-Agustin, University of Valencia
- Investigators
- Rodrigo Martín-San Agustín, Doctor, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472648
- Sponsor's protocol ID
- 1236358
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Instability Training Program Using Global Versus Selective Instability Devices on Dynamic Balance and Ankle Stability in Young Amateur Soccer Players
- ClinicalTrials.gov ID
- NCT06472648
- Acronym / sponsor ID
- 1236358
- Conditions
- Balance Instability Training
- Keywords
- Instability device, Amateur soccer players
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 21 Feb 2020 (actual)
- First posted
- 25 Jun 2024 (actual)
- 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 goal of this clinical trial was to compare the effects of a 4-week balance training programme using a GID or SID on functional dynamic balance and functional ankle stability in young healthy amateur soccer players.
The main question it aimed to answer are:
- Are there differences between using GID or SID in improving dynamic balance according to the Modified Star Excursion Balance Test (mSEBT) and the Emery test, and in improving functional ankle stability according to the Side Hop Test?
Participants were randomly allocated into two groups: GID balance training (i.e., with a BOSU®) and SID balance training (i.e., with Blackboard). The randomization and allocation were performed using the sealed envelope method. Both groups performed on a 4-weeks balance training program with the assigned device.
Participants were asked to:
- Perform a 5-minute conventional warm-up (cycling and active anke mobility exercises)
- Perform four balance exercises with a 3-kg medicine ball, on the unstable surface device assigned to each group (explanation of the exercises in the detailed description)
Researchers compared the results of the GID group with those of the SID group to determine the differences between devices in the improvement of dynamic balance and functional stability of the foot and ankle.
Detailed description
Sport injuries are one of the main concerns of soccer players and their coaching staff and ankle sprains are one of the most common injuries in this sport. Sprains have a high recurrence in soccer, leading to pathological laxity, residual pain, and sensorimotor deficits in the ankle which could cause stability alterations known as chronic ankle instability. In this sense, numerous efforts have been made to find alternatives to reduce the incidence and recurrence of ankle sprains, but the exercise protocols designed to date are still not completely effective. Therefore, studies that deal with exercises or devices that could produce changes in ankle stability and, consequently, can reduce injury rates, are still necessary.
Stability training programmes are generally performed on unstable surfaces such as Both Sides Utilized (BOSU®), balance boards, pads, soft mats, air cushions, or tilting platforms. These tools are generally considered global instability devices (GIDs) as the direction and intensity of the instability cannot be selected and adjusted by the user. Although not yet widely studied, a new device designed to overcome these limitations is the Blackboard Training, as selective instability device (SID). In a previous study, the investigators compared muscle activation of the peroneus longus during single-leg stance on the Blackboard Training and on other GIDs (including BOSU®), finding no differences between devices. These findings may suggest that the use of the SID to improve functional ankle balance in athlete's ankle sprain preventive programs could be effective, at least, as those produced by GID, but a clinical comparison has not yet been conducted.
Thus, the aim of this study was to compare the effects of a 4-week balance training programme using a GID or SID on functional dynamic balance and functional ankle stability in young healthy amateur soccer players.
A total number of 20 amateur soccer players were randomly allocated into two groups (GID and SID). Sociodemographic, anthropometric, dynamic balance (modified Star Excursion Balance Test and Emery Test) and ankle stability (Side Hop Test) data were collected.
After a 5-minute warm up, participants performed the same exercises on their assigned device (BOSU in its inverted position for the GID group, or Blackboard with the two slats placed centrally for the SID group), which was a modified version of a previously proposed plan for proprioception training in athletes. The exercises were the same for both groups and were performed with a 3-kg medicine ball, being the only difference the unstable surface device. These were the following:
- A 30-second series of maintaining the single-leg stance position with extended knee and hip holding the ball with the arms stretched out above the head; the free leg was kept at 90º hip and knee flexion.
- A series of 10 repetitions where the participant was asked to pass from the supporting-leg hip and knee starting position to a 90º knee flexion squat, keeping the ball above their heads and maintaining the other leg with the knee and hip about 90º flexed.
- A single series of 10 repetitions where the participant started with full limb extension of the supporting member and the ball held with both hands at chest height; from this position subjects were asked to bring the free leg from 45º hip extension to 45º hip flexion.
- 10 passes between the participant and a partner where the participants started with a total extension of the supporting limb and the ball held in both hands in front of them at chest height, and their free leg flexed 90º at the hip and the knee. A 2-minute rest between exercises was allowed.
The stability training programme was performed for a period of 4 weeks, with 3 weekly sessions using BOSU® or Blackboard at their soccer club before their usual training and under the supervision of a physical therapist. In all, 12 sessions were completed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GID group | Experimental | Other: Proprioception training exercise plan with BOSUGID: Global Instability Device. Out of the total sample, 10 subjects were randomly assigned to each group. The GID group consisted of 10 amateur soccer players, both men and women, who performed the intervention using the BOSU. |
| SID group | Experimental | Other: Proprioception training exercise plan with Blackboard (BB)SID: Specific Instability Device. Out of the total sample, 10 subjects were randomly assigned to each group. The SID group consisted of 10 amateur soccer players, both men and women, who performed the intervention using the Blackboard. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- No lower limb surgery during the last year prior to participation
- No history of pain in either ankles, knees or hips during the two months prior to participation
- Not having sprained either ankle for at least three months prior to participation
Key exclusion criteria (1 listed)
- Had participated in lower limb balance and proprioception programmes or had suffered balance alterations such as vertigo, vestibular or central disorders
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 |
|---|---|---|
| Proprioception training exercise plan with BOSUA 5' conventional warm-up (stationary cycling and active ankle mobility exercises) was performed. Ankle proprioception training exercise plan included: 1. A 30-second series of maintaining the single-leg stance position on the BOSU with extended knee and hip holding the ball with the arms stretched out above the head 2. A series of 10 reps on the BOSU where the subject was asked to pass from the supporting-leg hip and knee starting position to a 90º knee flexion squat, keeping the ball above their heads 3. A single series of 10 reps on the BOSU where the subject started with full limb extension of the supporting member and the ball held with both hands at chest height; from this position subjects were asked to bring the free leg from 45º hip extension to 45º hip flexion 4. 10 passes between the subject and a partner where the participants started with a total extension of the supporting limb on the BOSU and the ball held in both hands in front of them. 2' rest between exercises. | Other | GID group |
| Proprioception training exercise plan with Blackboard (BB)A 5' conventional warm-up (stationary cycling and active ankle mobility exercises) was performed. Ankle proprioception training exercise plan included: 1. A 30-second series of maintaining the single-leg stance position on the BB with extended knee and hip holding the ball with the arms stretched out above the head 2. A series of 10 reps on the BB where the subject was asked to pass from the supporting-leg hip and knee starting position to a 90º knee flexion squat, keeping the ball above their heads 3. A single series of 10 reps on the BB where the subject started with full limb extension of the supporting member and the ball held with both hands at chest height; from this position subjects were asked to bring the free leg from 45º hip extension to 45º hip flexion 4. 10 passes between the subject and a partner where the participants started with a total extension of the supporting limb on the BB and the ball held in both hands in front of them. 2' rest between exercises. | Other | SID group |
Primary outcome
Dynamic Balance (mSEBT)
Time frame: Pre and after 4 weeks of intervention
Firstly, for assessing dynamic balance, the three-directions modified Star Excursion Balance Test (mSEBT) and Emery Test were employed. The mSEBT consists of standing on one leg while reaching with the contralateral leg the farthest possible point in three different directions (anterior, posteromedial, and posterolateral). The distance reached in each attempt was normalised with the leg length. Each participant was allowed to make two attempts with each leg and in each direction to practice. Then, three more attempts were performed. A 15-second rest time was allowed between attempts of the same position, and five minutes between the different directions. All measurements were made barefoot and with hands placed on hips. The mSEBT has demonstrated excellent inter- and intra-rater reliability.
Dynamic Balance (Emery Test )
Time frame: Pre and after 4 weeks of intervention
For the Emery Test, subjects should maintain single-leg stance on an Airex® Balance Pad, with their eyes closed, barefoot, and with their hands placed on their hips. The subjects were asked to remain as stable as possible for a maximum time of 180 seconds. Three attempts were performed with 15-second rests and the best time obtained for each leg was registered. Before starting the measurements, the subjects were allowed to become familiarised with the test for 15 seconds.
Ankle stability (Side Hop Test)
Time frame: Pre and after 4 weeks of intervention
The test consists of jumping laterally on one leg 30 cm delimited by two lines marked on the ground. Participants performed 10 repetitions barefoot (a total of 20 jumps) in the shortest possible time. Each participant made three attempts with each leg, with 1-minute rests. The best time for each leg was registered. One repetition was allowed before starting for practice.
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 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Rodrigo Martín-San Agustín, Doctor principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioception training exercise plan with BOSU and Proprioception training exercise plan with Blackboard (BB) in people with Balance Instability Training, run by University of Valencia 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 3 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 Jun 2024. 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?
Dynamic Balance (mSEBT) (time frame: Pre and after 4 weeks of intervention). The study lists 3 primary outcomes in all. 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 Jun 2024.