Ankle SprainsNCT03428620
Effect of Mobilization in Conjunction With Exercise in Participants With a History of Chronic Ankle Instability
A study testing High Velocity Low Amplitude mobilization and Exercise protocol in people with Ankle Sprains, run by Shenandoah University at 2 sites in United States.
Trial summary
Our purpose is to examine the combined effects of thrust mobilization of the ankle joints in conjunction with a six-week rehabilitation program on functional performance in subjects reporting chronic ankle instability (CAI). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- High Velocity Low Amplitude mobilization and Exercise protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Feb 2018to Jun 2019
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 years of age
- A history of at least 1 significant ankle sprain (The initial sprain must have occurred at least 12 months prior to study enrollment, associated with inflammatory symptoms (pain, swelling, etc), created at least 1 interrupted day of desired physical activity)
- The most recent injury must have occurred more than 3 months prior to study enrollment.
- A history of the previously injured ankle joint "giving way" and/or recurrent sprain and/or "feelings of instability."
- Cumberland Ankle Instability Tool (CAIT) < 24
- Foot and Ankle Ability Measure (FAAM)42: ADL scale < 90%, Sport scale < 80%
Who cannot join
- A history of previous surgeries to the musculoskeletal structures (ie, bones, joint structures, nerves) in either limb of the lower extremity.
- A history of a fracture in either limb of the lower extremity requiring realignment
- Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least 1 interrupted day of desired physical activity
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Methodist University
Fayetteville, North Carolina, 28311
Todd Telemeco, DPT, PhD, 910-630-7216, ttelemeco@methodist.edu
Todd A Telemeco, DPT, PhD
- Recruiting
Shenandoah University
Winchester, Virginia, 22601
Cameron Bolton, DPT, 540-542-6540, cbolton16@su.edu
Sheri, PhD, PT, 5405457240, shale2@su.edu
About this study
Official title: Effect of a Six-week Rehabilitation Program in Conjunction With Thrust Mobilization on Lower Extremity Function in Subjects Reporting Chronic Ankle Instability
Our purpose is to examine the combined effects of thrust mobilization of the ankle joints in conjunction with a six-week rehabilitation program on functional performance in subjects reporting chronic ankle instability (CAI).
Read the detailed description
Joint mobilizations are reported to increase range of motion (ROM), postural control and proprioception, and decrease pain in individuals with CAI. However, there is no research supporting the combined effects of thrust mobilization and exercise on function in this population.
Inclusion and exclusion criterion have been established utilizing the International Ankle Consortium guidelines. Using a convenience sampling, participants will be randomized into the exercise only or mobilization (experimental) and exercise group. Both groups will undergo 12 supervised training sessions across a six-week period. The mobilization (experimental) group will also receive high-velocity-low-amplitude (HVLA) thrust mobilizations at the talocrural, proximal, and distal tibiofibular joints prior to the first three treatment sessions.
An examiner, who is blinded to involved limb and group allocation, will perform a baseline and six-week follow-up examination of joint mobility, range of motion, and functional performance. The participants will complete subjective outcome measures at baseline, 2 weeks, 4 weeks, and 6 weeks including the Foot and Ankle Ability Measurement (FAAM), FAAM-Sport, Ankle Joint Functional Assessment Tool (AJFAT), and the Cumberland Ankle Instability Tool (CAIT). Participants will also complete baseline and six-week follow up assessments of the figure-of-8 hop test, side hop test, and three directions of the Star Excursion Balance test (SEBT).
The exercise protocol is a modified version of the balance training program described by McKeon et al. Participants will complete this protocol twice a week for six weeks. Treatment sessions will last approximately 30 minutes. Participants will individually progress on particular exercises if zero errors are observed. In addition, all participants will be given a home exercise program (HEP) to complete every day of the week excluding treatment days.
The mobilization (experimental) group will receive HVLA thrust mobilizations at the three joints stated above for the first three sessions prior to completing the exercise protocol. Each mobilization will be performed one time at each joint. The order of joint mobilizations will be randomized prior to administering.
Data analysis will be performed using International Business Machines Statistical Package for the Social Sciences (SPSS). Alpha level will be set p<0.05. Expecting to utilize separate 2 x 2 repeated measures analysis of variance (ANOVA) to assess changes in the FAAM, FAAM-Sport, AJFAT, CAIT, figure-of-8 hop test, side hop test, and three directions of the SEBT.
- Conditions
- Ankle Sprains
- Being tested
- High Velocity Low Amplitude mobilization, Exercise protocol
- Keywords
- Functional Performance, Rehabilitation, Manipulation
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Velocity Low Amplitude mobilizationOther
Also called HVLA, thrust mobilization
Mobilizations will be performed one time at each joint, prior to completing the exercise protocol during the first three treatment sessions.
Exercise protocolOther
This exercise regimen is a modified version of the balance training program described by McKeon et al.
| Study group | Role | What they receive |
|---|---|---|
| Mobilization | Experimental | High Velocity Low Amplitude mobilization group. The three joints that will be manipulated include proximal tibiofibular, the distal tibiofibular, and talocrural joints and will be mobilized the first three sessions prior to the participants performing the exercise protocol. Receives: Other: High Velocity Low Amplitude mobilization; Other: Exercise protocol |
| Exercise Protocol | Active comparator | This exercise regimen is a modified version of the balance training program described by McKeon et al. Receives: Other: Exercise protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline Figure-of-8 hop test at 6 weeks.
The participant begins the test on either side of a demarcated 5-meter distance. While standing on the involved ankle, the participant is instructed to "hop on one foot, as fast as you can," twice around the figure 8. Two trials will be performed with the fastest time being recorded.
Measured: Baseline and 6 weeks
Change in baseline Side hop test at 6 weeks
The participant stands on the involved limb on either side of two lines that are 30 cm apart. They are then instructed to "hop on one foot, as fast as you can," laterally and then back to the starting position. This is counted as two repetitions and 10 repetitions are performed. If the participant lands on or between the lines, this repetition does not count and they continue until 10 good repetitions are completed. Participants perform two trials and the fastest time is recorded.
Measured: Baseline and 6 weeks
Change in baseline Star Excursion Balance Test (SEBT) at 6 weeks
Each participant is asked to maintain single-limb stance, with hands on their hips, while reaching in anterior, posteromedial, and posterolateral directions.
Measured: Baseline and 6 weeks
Change in baseline Foot and Ankle Ability Measure (FAAM)- Activities of Daily Living (ADL) Subscale at 6 weeks
The FAAM- ADL is a 21-item tool that is designed to assess functional limitations related to foot and ankle conditions. Each item is scored on a Likert scale; 0 (unable to do) to 4 (no difficulty) and has total point value of 84 points, reported as a percent value.
Measured: Baseline and 6 weeks
Change in baseline Foot and Ankle Ability Measure (FAAM)- Sport subscale at 6 weeks
The FAAM- Sport is a 7-item tool that is a sub-scale of the FAAM. Each item is scored on a Likert scale; 0 (unable to do) to 4 (no difficulty) with a total point value of 28 points, reported as a percent value.
Measured: Baseline and 6 weeks
Change in baseline Ankle Joint Functional Assessment Tool (AJFAT) at 6 weeks
12-item tool that rates the participant's overall perceived level of function. Each item is assigned a point value from 0 (much less than other ankle) to 4 (much more than other ankle) with a possible total value of 48 points.
Measured: Baseline and 6 weeks
Change in baseline Cumberland Ankle Instability Tool (CAIT) at 6 weeks.
9-item questionnaire that helps discriminate and measure the severity of functional ankle instability.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start14 Feb 2018
- Primary completionJan 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ankle SprainsStudies 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
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenandoah University
- Sponsor type
- University, hospital or other
- Collaborators
- Methodist University, North Carolina
- Responsible party
- Principal investigator, Cameron Bolton, Shenandoah University
- Investigators
- Cameron J Bolton, DPT, Principal investigator, Shenandoah UniversitySheri Hale, PhD, PT, Principal investigator, Shenandoah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428620
- Sponsor's protocol ID
- 511
- Status last verified
- Apr 2018
- First submitted
- 5 Feb 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gribble PA, Delahunt E, Bleakley CM, Caulfield B, Docherty CL, Fong DT, Fourchet F, Hertel J, Hiller CE, Kaminski TW, McKeon PO, Refshauge KM, van der Wees P, Vicenzino W, Wikstrom EA. Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium. J Athl Train. 2014 Jan-Feb;49(1):121-7. doi: 10.4085/1062-6050-49.1.14. Epub 2013 Dec 30.
PubMed 24377963McKeon PO, Ingersoll CD, Kerrigan DC, Saliba E, Bennett BC, Hertel J. Balance training improves function and postural control in those with chronic ankle instability. Med Sci Sports Exerc. 2008 Oct;40(10):1810-9. doi: 10.1249/MSS.0b013e31817e0f92.
PubMed 18799992Hale SA, Hertel J, Olmsted-Kramer LC. The effect of a 4-week comprehensive rehabilitation program on postural control and lower extremity function in individuals with chronic ankle instability. J Orthop Sports Phys Ther. 2007 Jun;37(6):303-11. doi: 10.2519/jospt.2007.2322.
PubMed 17612356Beazell JR, Grindstaff TL, Sauer LD, Magrum EM, Ingersoll CD, Hertel J. Effects of a proximal or distal tibiofibular joint manipulation on ankle range of motion and functional outcomes in individuals with chronic ankle instability. J Orthop Sports Phys Ther. 2012 Feb;42(2):125-34. doi: 10.2519/jospt.2012.3729. Epub 2012 Feb 1.
PubMed 22333567
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Six-week Rehabilitation Program in Conjunction With Thrust Mobilization on Lower Extremity Function in Subjects Reporting Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT03428620
- Acronym / sponsor ID
- 511
- Conditions
- Ankle Sprains
- Keywords
- Functional Performance, Rehabilitation, Manipulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shenandoah UniversityUniversity, hospital or other
- Collaborators
- Methodist University, North Carolina
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 9 Feb 2018 (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.
Our purpose is to examine the combined effects of thrust mobilization of the ankle joints in conjunction with a six-week rehabilitation program on functional performance in subjects reporting chronic ankle instability (CAI).
Detailed description
Joint mobilizations are reported to increase range of motion (ROM), postural control and proprioception, and decrease pain in individuals with CAI. However, there is no research supporting the combined effects of thrust mobilization and exercise on function in this population.
Inclusion and exclusion criterion have been established utilizing the International Ankle Consortium guidelines. Using a convenience sampling, participants will be randomized into the exercise only or mobilization (experimental) and exercise group. Both groups will undergo 12 supervised training sessions across a six-week period. The mobilization (experimental) group will also receive high-velocity-low-amplitude (HVLA) thrust mobilizations at the talocrural, proximal, and distal tibiofibular joints prior to the first three treatment sessions.
An examiner, who is blinded to involved limb and group allocation, will perform a baseline and six-week follow-up examination of joint mobility, range of motion, and functional performance. The participants will complete subjective outcome measures at baseline, 2 weeks, 4 weeks, and 6 weeks including the Foot and Ankle Ability Measurement (FAAM), FAAM-Sport, Ankle Joint Functional Assessment Tool (AJFAT), and the Cumberland Ankle Instability Tool (CAIT). Participants will also complete baseline and six-week follow up assessments of the figure-of-8 hop test, side hop test, and three directions of the Star Excursion Balance test (SEBT).
The exercise protocol is a modified version of the balance training program described by McKeon et al. Participants will complete this protocol twice a week for six weeks. Treatment sessions will last approximately 30 minutes. Participants will individually progress on particular exercises if zero errors are observed. In addition, all participants will be given a home exercise program (HEP) to complete every day of the week excluding treatment days.
The mobilization (experimental) group will receive HVLA thrust mobilizations at the three joints stated above for the first three sessions prior to completing the exercise protocol. Each mobilization will be performed one time at each joint. The order of joint mobilizations will be randomized prior to administering.
Data analysis will be performed using International Business Machines Statistical Package for the Social Sciences (SPSS). Alpha level will be set p<0.05. Expecting to utilize separate 2 x 2 repeated measures analysis of variance (ANOVA) to assess changes in the FAAM, FAAM-Sport, AJFAT, CAIT, figure-of-8 hop test, side hop test, and three directions of the SEBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobilization | Experimental | Other: High Velocity Low Amplitude mobilization, Other: Exercise protocolHigh Velocity Low Amplitude mobilization group. The three joints that will be manipulated include proximal tibiofibular, the distal tibiofibular, and talocrural joints and will be mobilized the first three sessions prior to the participants performing the exercise protocol. |
| Exercise Protocol | Active comparator | Other: Exercise protocolThis exercise regimen is a modified version of the balance training program described by McKeon et al. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-35 years of age
- A history of at least 1 significant ankle sprain (The initial sprain must have occurred at least 12 months prior to study enrollment, associated with inflammatory symptoms (pain, swelling, etc), created at least 1 interrupted day of desired physical activity)
- The most recent injury must have occurred more than 3 months prior to study enrollment.
- A history of the previously injured ankle joint "giving way" and/or recurrent sprain and/or "feelings of instability."
- Cumberland Ankle Instability Tool (CAIT) < 24
Key exclusion criteria (3 listed)
- A history of previous surgeries to the musculoskeletal structures (ie, bones, joint structures, nerves) in either limb of the lower extremity.
- A history of a fracture in either limb of the lower extremity requiring realignment
- Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least 1 interrupted day of desired physical activity
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 |
|---|---|---|
| High Velocity Low Amplitude mobilizationAlso: HVLA, thrust mobilizationMobilizations will be performed one time at each joint, prior to completing the exercise protocol during the first three treatment sessions. | Other | Mobilization |
| Exercise protocolThis exercise regimen is a modified version of the balance training program described by McKeon et al. | Other | Exercise Protocol, Mobilization |
Primary outcome
Change in baseline Figure-of-8 hop test at 6 weeks.
Time frame: Baseline and 6 weeks
The participant begins the test on either side of a demarcated 5-meter distance. While standing on the involved ankle, the participant is instructed to "hop on one foot, as fast as you can," twice around the figure 8. Two trials will be performed with the fastest time being recorded.
Change in baseline Side hop test at 6 weeks
Time frame: Baseline and 6 weeks
The participant stands on the involved limb on either side of two lines that are 30 cm apart. They are then instructed to "hop on one foot, as fast as you can," laterally and then back to the starting position. This is counted as two repetitions and 10 repetitions are performed. If the participant lands on or between the lines, this repetition does not count and they continue until 10 good repetitions are completed. Participants perform two trials and the fastest time is recorded.
Change in baseline Star Excursion Balance Test (SEBT) at 6 weeks
Time frame: Baseline and 6 weeks
Each participant is asked to maintain single-limb stance, with hands on their hips, while reaching in anterior, posteromedial, and posterolateral directions.
Change in baseline Foot and Ankle Ability Measure (FAAM)- Activities of Daily Living (ADL) Subscale at 6 weeks
Time frame: Baseline and 6 weeks
The FAAM- ADL is a 21-item tool that is designed to assess functional limitations related to foot and ankle conditions. Each item is scored on a Likert scale; 0 (unable to do) to 4 (no difficulty) and has total point value of 84 points, reported as a percent value.
Change in baseline Foot and Ankle Ability Measure (FAAM)- Sport subscale at 6 weeks
Time frame: Baseline and 6 weeks
The FAAM- Sport is a 7-item tool that is a sub-scale of the FAAM. Each item is scored on a Likert scale; 0 (unable to do) to 4 (no difficulty) with a total point value of 28 points, reported as a percent value.
Change in baseline Ankle Joint Functional Assessment Tool (AJFAT) at 6 weeks
Time frame: Baseline and 6 weeks
12-item tool that rates the participant's overall perceived level of function. Each item is assigned a point value from 0 (much less than other ankle) to 4 (much more than other ankle) with a possible total value of 48 points.
Change in baseline Cumberland Ankle Instability Tool (CAIT) at 6 weeks.
Time frame: Baseline and 6 weeks
9-item questionnaire that helps discriminate and measure the severity of functional ankle instability.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Background: PubMed 24377963Gribble PA, Delahunt E, Bleakley CM, Caulfield B, Docherty CL, Fong DT, Fourchet F, Hertel J, Hiller CE, Kaminski TW, McKeon PO, Refshauge KM, van der Wees P, Vicenzino W, Wikstrom EA. Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium. J Athl Train. 2014 Jan-Feb;49(1):121-7. doi: 10.4085/1062-6050-49.1.14. Epub 2013 Dec 30.
- Background: PubMed 18799992McKeon PO, Ingersoll CD, Kerrigan DC, Saliba E, Bennett BC, Hertel J. Balance training improves function and postural control in those with chronic ankle instability. Med Sci Sports Exerc. 2008 Oct;40(10):1810-9. doi: 10.1249/MSS.0b013e31817e0f92.
- Background: PubMed 17612356Hale SA, Hertel J, Olmsted-Kramer LC. The effect of a 4-week comprehensive rehabilitation program on postural control and lower extremity function in individuals with chronic ankle instability. J Orthop Sports Phys Ther. 2007 Jun;37(6):303-11. doi: 10.2519/jospt.2007.2322.
- Background: PubMed 22333567Beazell JR, Grindstaff TL, Sauer LD, Magrum EM, Ingersoll CD, Hertel J. Effects of a proximal or distal tibiofibular joint manipulation on ankle range of motion and functional outcomes in individuals with chronic ankle instability. J Orthop Sports Phys Ther. 2012 Feb;42(2):125-34. doi: 10.2519/jospt.2012.3729. Epub 2012 Feb 1.
- Individual participant dataSharing planned: Undecided
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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.
Cameron J Bolton, DPT principal investigator
Shenandoah University
Sheri Hale, PhD, PT principal investigator
Shenandoah University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Velocity Low Amplitude mobilization and Exercise protocol in people with Ankle Sprains, run by Shenandoah University at 2 sites 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 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: status not confirmed, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cameron J Bolton, DPT (5405426540, cbolton16@su.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline Figure-of-8 hop test at 6 weeks. (time frame: Baseline and 6 weeks). The study lists 7 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 NCT03428620, which also lists 4 linked publications.
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 17 Apr 2018.