Balance Training GroupNCT06401681
Cross-Education for Chronic Ankle Instability
A study testing Balance training in people with Balance Training Group and Control Group, run by Old Dominion University at 1 site in United States.
Trial summary
Chronic ankle instability (CAI) results in neuromuscular impairments compromising balance, lumbopelvic stability, and hip strength. Balance training has proven to be an effective intervention for individuals with CAI. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Balance Training Group, Control Group
- What is being tested?
- Balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2019to 24 May 2022
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All participants were required to have CAI based on guidelines published by the International Ankle Consortium. Participants were required to have a history of at least one acute LAS that resulted in swelling, pain, and at least one day of missed activity. The initial LAS must have occurred at least 12 months before study enrollment and the participants needed to be free of ankle sprains in the past three months. Participants were also required to report at least two events of "giving way" of their ankle, instability, or reinjury within the previous six months. Lastly, participants had to record scores of ≥5 on the Ankle Instability Instrument (AII), >11 on the Identification of Functional Ankle Instability (IdFAI), and <24 on the Cumberland Ankle Instability Tool (CAIT).2 One member of the research team completed all screening procedures. The same person block randomized participants into two groups, control (CON) and balance training (BAL), by selecting a sealed envelope that contained group designation.
Who cannot join
- Participants were excluded if they had any history of lower extremity or spine fracture or surgery, any lower extremity or spine injury besides LAS within the past two years, and any significant ankle injury within the past three months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Old Dominion University Athletic Training Laboratory
Norfolk, Virginia, 20529
About this study
Official title: Cross-Education Effects of Balance Training in Individuals With Chronic Ankle Instability
Chronic ankle instability (CAI) results in neuromuscular impairments compromising balance, lumbopelvic stability, and hip strength. Balance training has proven to be an effective intervention for individuals with CAI. Additionally, unilateral balance training for those with CAI has previously led to cross-education effects in which the untrained limb exhibited improved balance performance. However, the ability of unilateral balance training to improve contralateral hip strength and lumbopelvic stability in those with CAI is unknown. The purpose of this study was to determine the cross-education effects of balance training on hip strength and lumbopelvic stability in individuals with CAI.
Thirty individuals with CAI will be randomized into control (CON) and balance (BAL) groups. Baseline testing include a unilateral hip bridge, hip strength, and balance tests of the uninvolved limb. For the unilateral hip bridge, the participant will hold a bridge through the test limb for maximum time. Isometric hip strength will be measured for external rotation (ER), extension (EXT), and abduction (ABD) using a handheld dynamometer. The star excursion balance test (SEBT) requires participants to maintain a single-leg stance while reaching for maximum distance with the opposite leg in three directions: anterior (SEBT-ANT), posterolateral (SEBT-PL), and posteromedial (SEBT-PM). The BAL group will participate in a progressive balance training program three times a week for eight weeks for the involved limb, whereas CON will not. All baseline measures will be reassessed at the end of the 8 weeks. Separate 2-way repeated measures ANOVAs will analyze the effects of group and time on each outcome. Additionally, each group's mean changes from baseline to post-intervention will be assessed with Cohen's d effect sizes. Statistical significance is set a priori at P<0.05.
- Conditions
- Balance Training Group, Control Group
- Being tested
- Balance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance trainingOther
Also called balance exercise, balance rehabilitation
The balance exercises consist of single limb stances with eyes open and closed, single-leg hops with stabilization, and single-leg hops and reach. Thirty-second breaks will be provided between exercise sets. Progressions for single-leg stance exercises involve longer durations and introduction of unstable surfaces. Progressions for hopping exercises involve longer hopping distances. To progress to the next level, participants must complete a balance training session without any errors. Errors include 1) touching the floor or bracing with the opposite limb, 2) excessive lateral trunk flexion or hip abduction, 3) hands coming off hips (hop tasks) or shoulders (stance tasks), 4) missing the landing target, 5) using the reach leg for a substantial amount of weight bearing.
| Study group | Role | What they receive |
|---|---|---|
| Balance training (BAL) | Experimental | Within one day of baseline testing, BAL will begin a progressive balance training protocol on the involved limb. The balance training program consists of three 20-minute sessions per week for eight weeks. Post-test assessments for BAL will completed within one week of completing the 8-week training interval. Receives: Other: Balance training |
| Control (CON) | No intervention | After baseline testing, CON will be instructed to continue their normal daily routine. They will not participate in the balance training intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Star Excursion Balance Test of the Uninvolved Limb
The Star Excursion Balance Test (SEBT) measured balance performance through a series of lower body reaches in anterior, posterolateral, and posteromedial directions. Participants maintained a single-leg stance on the uninvolved limb while reaching with their non-stance limb for maximal distance along a tape measure fixed to the floor. Participants were required to maintain their hands on their hips and keep their stance limb flat against the floor. As a common practice, there were four practice trials and three test trials for each direction performed. For each SEBT direction, we averaged the three reach scores and normalized them as a percent of the stance leg length, measured from the anterior superior iliac spine to the most distal part of the medial malleoli.
Measured: 10 minutes
Isometric hip strength of the Uninvolved Limb
Isometric hip strength was measured via handheld dynamometry for extension, abduction, and external rotation. Participants completed one practice trial and three test trials for each motion in random order. Each trial lasted 5 seconds, with the first 3 seconds gradually increasing force and then the final two seconds exerting maximum force. We averaged the three trials for each hip strength test, multiplied by the length of the moment arm, and divided by body mass to calculate normalized torque (Nm/kg). We measured EXT and ABD moment arms from the greater trochanter to the lateral femoral epicondyle and ER moment arm from the medial tibial plateau to the distal end of the medial malleolus.
Measured: 15 minutes
Lumbopelvic stability of the Uninvolved Limb
We measured lumbopelvic stability with a unilateral hip bridge test. Participants began in a hook-lying position with their arms folded across their chest. Participants completed an initial double-leg bridge to find a neutral alignment of the spine and hips.To start the unilateral hip bridge, participants initiated another bilateral hip bridge, then extended the non-test knee and kept their thighs in parallel. Participants completed a single trial for maximal time (s).
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start8 May 2019
- Primary completion24 May 2022
- Study completion24 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Balance Training GroupStudies 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Old Dominion University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan McCann, Old Dominion University
- Investigators
- Ryan McCann, PhD, Principal investigator, Old Dominion University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401681
- Sponsor's protocol ID
- 1407520-8
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reyes MC, Suttmiller AM, Chung S, Gruskiewicz VM, Johnson KR, Foreman NN, McCann RS. Cross-education effects of balance training in individuals with chronic ankle instability. J Bodyw Mov Ther. 2024 Oct;40:1263-1268. doi: 10.1016/j.jbmt.2024.07.042. Epub 2024 Jul 23.
PubMed 39593444
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Education Effects of Balance Training in Individuals With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT06401681
- Acronym / sponsor ID
- 1407520-8
- Conditions
- Balance Training Group, Control Group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Old Dominion UniversityUniversity, hospital or other
- Study start
- 8 May 2019 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 7 May 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.
Chronic ankle instability (CAI) results in neuromuscular impairments compromising balance, lumbopelvic stability, and hip strength. Balance training has proven to be an effective intervention for individuals with CAI. Additionally, unilateral balance training for those with CAI has previously led to cross-education effects in which the untrained limb exhibited improved balance performance. However, the ability of unilateral balance training to improve contralateral hip strength and lumbopelvic stability in those with CAI is unknown. The purpose of this study was to determine the cross-education effects of balance training on hip strength and lumbopelvic stability in individuals with CAI.
Thirty individuals with CAI will be randomized into control (CON) and balance (BAL) groups. Baseline testing include a unilateral hip bridge, hip strength, and balance tests of the uninvolved limb. For the unilateral hip bridge, the participant will hold a bridge through the test limb for maximum time. Isometric hip strength will be measured for external rotation (ER), extension (EXT), and abduction (ABD) using a handheld dynamometer. The star excursion balance test (SEBT) requires participants to maintain a single-leg stance while reaching for maximum distance with the opposite leg in three directions: anterior (SEBT-ANT), posterolateral (SEBT-PL), and posteromedial (SEBT-PM). The BAL group will participate in a progressive balance training program three times a week for eight weeks for the involved limb, whereas CON will not. All baseline measures will be reassessed at the end of the 8 weeks. Separate 2-way repeated measures ANOVAs will analyze the effects of group and time on each outcome. Additionally, each group's mean changes from baseline to post-intervention will be assessed with Cohen's d effect sizes. Statistical significance is set a priori at P<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance training (BAL) | Experimental | Other: Balance trainingWithin one day of baseline testing, BAL will begin a progressive balance training protocol on the involved limb. The balance training program consists of three 20-minute sessions per week for eight weeks. Post-test assessments for BAL will completed within one week of completing the 8-week training interval. |
| Control (CON) | No intervention | –After baseline testing, CON will be instructed to continue their normal daily routine. They will not participate in the balance training intervention. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All participants were required to have CAI based on guidelines published by the International Ankle Consortium. Participants were required to have a history of at least one acute LAS that resulted in swelling, pain, and at least one day of missed activity. The initial LAS must have occurred at least 12 months before study enrollment and the participants needed to be free of ankle sprains in the past three months. Participants were also required to report at least two events of "giving way" of their ankle, instability, or reinjury within the previous six months. Lastly, participants had to record scores of ≥5 on the Ankle Instability Instrument (AII), >11 on the Identification of Functional Ankle Instability (IdFAI), and <24 on the Cumberland Ankle Instability Tool (CAIT).2 One member of the research team completed all screening procedures. The same person block randomized participants into two groups, control (CON) and balance training (BAL), by selecting a sealed envelope that contained group designation.
Key exclusion criteria (1 listed)
- Participants were excluded if they had any history of lower extremity or spine fracture or surgery, any lower extremity or spine injury besides LAS within the past two years, and any significant ankle injury within the past three months.
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 |
|---|---|---|
| Balance trainingAlso: balance exercise, balance rehabilitationThe balance exercises consist of single limb stances with eyes open and closed, single-leg hops with stabilization, and single-leg hops and reach. Thirty-second breaks will be provided between exercise sets. Progressions for single-leg stance exercises involve longer durations and introduction of unstable surfaces. Progressions for hopping exercises involve longer hopping distances. To progress to the next level, participants must complete a balance training session without any errors. Errors include 1) touching the floor or bracing with the opposite limb, 2) excessive lateral trunk flexion or hip abduction, 3) hands coming off hips (hop tasks) or shoulders (stance tasks), 4) missing the landing target, 5) using the reach leg for a substantial amount of weight bearing. | Other | Balance training (BAL) |
Primary outcome
Star Excursion Balance Test of the Uninvolved Limb
Time frame: 10 minutes
The Star Excursion Balance Test (SEBT) measured balance performance through a series of lower body reaches in anterior, posterolateral, and posteromedial directions. Participants maintained a single-leg stance on the uninvolved limb while reaching with their non-stance limb for maximal distance along a tape measure fixed to the floor. Participants were required to maintain their hands on their hips and keep their stance limb flat against the floor. As a common practice, there were four practice trials and three test trials for each direction performed. For each SEBT direction, we averaged the three reach scores and normalized them as a percent of the stance leg length, measured from the anterior superior iliac spine to the most distal part of the medial malleoli.
Isometric hip strength of the Uninvolved Limb
Time frame: 15 minutes
Isometric hip strength was measured via handheld dynamometry for extension, abduction, and external rotation. Participants completed one practice trial and three test trials for each motion in random order. Each trial lasted 5 seconds, with the first 3 seconds gradually increasing force and then the final two seconds exerting maximum force. We averaged the three trials for each hip strength test, multiplied by the length of the moment arm, and divided by body mass to calculate normalized torque (Nm/kg). We measured EXT and ABD moment arms from the greater trochanter to the lateral femoral epicondyle and ER moment arm from the medial tibial plateau to the distal end of the medial malleolus.
Lumbopelvic stability of the Uninvolved Limb
Time frame: 2 minutes
We measured lumbopelvic stability with a unilateral hip bridge test. Participants began in a hook-lying position with their arms folded across their chest. Participants completed an initial double-leg bridge to find a neutral alignment of the spine and hips.To start the unilateral hip bridge, participants initiated another bilateral hip bridge, then extended the non-test knee and kept their thighs in parallel. Participants completed a single trial for maximal time (s).
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 7 May 2024.
- Derived from this study: PubMed 39593444Reyes MC, Suttmiller AM, Chung S, Gruskiewicz VM, Johnson KR, Foreman NN, McCann RS. Cross-education effects of balance training in individuals with chronic ankle instability. J Bodyw Mov Ther. 2024 Oct;40:1263-1268. doi: 10.1016/j.jbmt.2024.07.042. Epub 2024 Jul 23.
- 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.
Ryan McCann, PhD principal investigator
Old Dominion University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance training in people with Balance Training Group and Control Group, run by Old Dominion University at 1 site in United States.
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 7 May 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 United States. 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?
Star Excursion Balance Test of the Uninvolved Limb (time frame: 10 minutes). 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?
On the ClinicalTrials.gov record for NCT06401681, which also lists 1 linked publication.
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 7 May 2024.