Chronic Ankle InstabilityNCT03447652
A Study Investigating The Effects Of An Ankle Rehabilitation Program On High School Athletes With Ankle Instability
A study testing Resistance Band Ankle Rehabilitation, Biomechanical Ankle Platform System Rehabilitation and Combination Rehabilitation in people with Chronic Ankle Instability and Ankle Sprains, run by Georgia State University at 7 sites in United States.
Trial summary
A randomized controlled trial investigating the effects of a 4-week ankle rehabilitation program on high school athletes with chronic ankle instability. Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Ankle Instability, Ankle Sprains, Ankle Rehabilitation
- What is being tested?
- Resistance Band Ankle Rehabilitation, Biomechanical Ankle Platform System Rehabilitation and Combination Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 7 sitesUnited States
- Study dates
- 14 Aug 2017to 30 Aug 2018
- 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 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- active for at least 1.5 hours a week, a history of at least 1 significant ankle sprain that required medical intervention, repeated symptoms of pain, swelling, weakness, instability, and repeated episodes of "giving way".
Who cannot join
- presence of any current lower extremity injury (diagnosed by a medical professional within last 3 months with present symptoms), previous surgery to either leg, diagnosed ankle sprain within the past 6 weeks, history of ankle fractures and/or dislocations.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Holy Innocents' Episcopal School
Atlanta, Georgia, 30327
The Lovett School
Atlanta, Georgia, 30327
The Westminister Schools
Atlanta, Georgia, 30327
Woodward Academy
College Park, Georgia, 30337
Decatur High School
Decatur, Georgia, 30030
The Walker School
Marietta, Georgia, 30062
Walton High School
Marietta, Georgia, 30062
About this study
Official title: A Randomized Controlled Trial Investigating The Effects Of A 4-Week Ankle Rehabilitation Program On High School Athletes With Chronic Ankle Instability
A randomized controlled trial investigating the effects of a 4-week ankle rehabilitation program on high school athletes with chronic ankle instability.
Read the detailed description
A randomized controlled trial investigating the effects of a three different 4-week ankle rehabilitation programs on high school athletes with chronic ankle instability. We will use questionnaires to assess subjective level of function and clinical measures to assess clinical functionality via static and functional balance.
- Being tested
- Resistance Band Ankle Rehabilitation, Biomechanical Ankle Platform System Rehabilitation, Combination Rehabilitation
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Band Ankle RehabilitationOther
Resistance Band - uses a tension band to provide resistance during ankle motion
Biomechanical Ankle Platform System RehabilitationOther
Biomechanical Ankle Platform System Board Group - uses different levels of half spheres to increase the amount of motion allowed at the ankle.
Combination RehabilitationOther
Combination Group - includes both the resistance band and Biomechanical Ankle Platform System programs.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Each patient in the control group did not perform any rehabilitation exercises. Over the intervention time frame, the patient was required to check in with a member of the research team each week to discuss any changes in their ankle or report any injury incidence. |
| Resistance Band Group | Experimental | Each session, patients completed resistance training using a resistance band in 4 directions of ankle motion (plantarflexion, dorsiflexion, inversion and eversion). Patients would complete 3 sets of 10 repetitions during each session. Every 3 sessions, the band resistance would increase. Receives: Other: Resistance Band Ankle Rehabilitation |
| Biomechanical Ankle Platform System | Experimental | The Biomechanical Ankle Platform System board is an oval shaped board that utilizes a half-sphere on the bottom of the board to allow the patient to train on an unstable surface. A one legged stance on their involved limb was performed on the Biomechanical Ankle Platform System board while clockwise and counterclockwise circles were completed. The initial rotation of direction was selected by the patient and changed every 10 seconds of the 40-second trial. Five 40-second trials were completed with 1-minute rest intervals in between the trials. Progression was determined by the supervising clinician and was based on the patient's ability to make smooth transitions between direction changes and completion of smooth circular rotations in both directions. Receives: Other: Biomechanical Ankle Platform System Rehabilitation |
| Combination Group | Experimental | Patients completing the combination protocol completed both the resistance band and Biomechanical Ankle Platform System board protocols during each session. The order of exercise completion was counterbalanced for each session. Receives: Other: Combination Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Balance Assessments
Static Balance Clinical Tests
Measured: 4 weeks
Functional Balance Assessments
Functional Balance Clinical Tests
Measured: 4 weeks
Patient Self-reported Outcomes
Subjective Patient Reported Outcome Questionnaires
Measured: 4 to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start14 Aug 2017
- Primary completion13 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (104)Papers the sponsor has linked to this study.
- Other trials for Chronic Ankle InstabilityStudies 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
- Model description
- 4 independent groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)
- Responsible party
- Principal investigator, Mary Spencer Cain, Georgia State University
- Investigators
- Benjamin M Goerger, PhD, Study director, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447652
- Sponsor's protocol ID
- CON006264
- Status last verified
- Oct 2018
- First submitted
- 28 Jan 2018
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data is planned to be shared with other researchers.
Publications
Leininger RE, Knox CL, Comstock RD. Epidemiology of 1.6 million pediatric soccer-related injuries presenting to US emergency departments from 1990 to 2003. Am J Sports Med. 2007 Feb;35(2):288-93. doi: 10.1177/0363546506294060. Epub 2006 Nov 7.
PubMed 17092927Waterman BR, Owens BD, Davey S, Zacchilli MA, Belmont PJ Jr. The epidemiology of ankle sprains in the United States. J Bone Joint Surg Am. 2010 Oct 6;92(13):2279-84. doi: 10.2106/JBJS.I.01537.
PubMed 20926721Anandacoomarasamy A, Barnsley L. Long term outcomes of inversion ankle injuries. Br J Sports Med. 2005 Mar;39(3):e14; discussion e14. doi: 10.1136/bjsm.2004.011676.
PubMed 15728682Hertel J. Functional Anatomy, Pathomechanics, and Pathophysiology of Lateral Ankle Instability. J Athl Train. 2002 Dec;37(4):364-375.
PubMed 12937557Hiller CE, Kilbreath SL, Refshauge KM. Chronic ankle instability: evolution of the model. J Athl Train. 2011 Mar-Apr;46(2):133-41. doi: 10.4085/1062-6050-46.2.133.
PubMed 21391798Gribble PA, Delahunt E, Bleakley C, Caulfield B, Docherty CL, Fourchet F, Fong D, Hertel J, Hiller C, Kaminski TW, McKeon PO, Refshauge KM, van der Wees P, Vicenzino B, Wikstrom EA. Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium. J Orthop Sports Phys Ther. 2013 Aug;43(8):585-91. doi: 10.2519/jospt.2013.0303. Epub 2013 Jul 31.
PubMed 23902805Wikstrom EA, Hubbard-Turner T, McKeon PO. Understanding and treating lateral ankle sprains and their consequences: a constraints-based approach. Sports Med. 2013 Jun;43(6):385-93. doi: 10.1007/s40279-013-0043-z.
PubMed 23580392Harrington KD. Degenerative arthritis of the ankle secondary to long-standing lateral ligament instability. J Bone Joint Surg Am. 1979 Apr;61(3):354-61.
PubMed 429402Hintermann B, Boss A, Schafer D. Arthroscopic findings in patients with chronic ankle instability. Am J Sports Med. 2002 May-Jun;30(3):402-9. doi: 10.1177/03635465020300031601.
PubMed 12016082Hirose K, Murakami G, Minowa T, Kura H, Yamashita T. Lateral ligament injury of the ankle and associated articular cartilage degeneration in the talocrural joint: anatomic study using elderly cadavers. J Orthop Sci. 2004;9(1):37-43. doi: 10.1007/s00776-003-0732-9.
PubMed 14767703Kotlarz H, Gunnarsson CL, Fang H, Rizzo JA. Insurer and out-of-pocket costs of osteoarthritis in the US: evidence from national survey data. Arthritis Rheum. 2009 Dec;60(12):3546-53. doi: 10.1002/art.24984.
PubMed 19950287Verhagen RA, de Keizer G, van Dijk CN. Long-term follow-up of inversion trauma of the ankle. Arch Orthop Trauma Surg. 1995;114(2):92-6. doi: 10.1007/BF00422833.
PubMed 7734241Global Health Risks: Mortality and Burden of Disease Attributable to Selected Major RIsks. Geneva: World Health Organization; 2012
Wester JU, Jespersen SM, Nielsen KD, Neumann L. Wobble board training after partial sprains of the lateral ligaments of the ankle: a prospective randomized study. J Orthop Sports Phys Ther. 1996 May;23(5):332-6. doi: 10.2519/jospt.1996.23.5.332.
PubMed 8728532Osborne MD, Rizzo TD Jr. Prevention and treatment of ankle sprain in athletes. Sports Med. 2003;33(15):1145-50. doi: 10.2165/00007256-200333150-00005.
PubMed 14719982
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Investigating The Effects Of A 4-Week Ankle Rehabilitation Program On High School Athletes With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT03447652
- Acronym / sponsor ID
- CON006264
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Collaborators
- National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 27 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.
A randomized controlled trial investigating the effects of a 4-week ankle rehabilitation program on high school athletes with chronic ankle instability.
Detailed description
A randomized controlled trial investigating the effects of a three different 4-week ankle rehabilitation programs on high school athletes with chronic ankle instability. We will use questionnaires to assess subjective level of function and clinical measures to assess clinical functionality via static and functional balance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 4 independent groups
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Each patient in the control group did not perform any rehabilitation exercises. Over the intervention time frame, the patient was required to check in with a member of the research team each week to discuss any changes in their ankle or report any injury incidence. |
| Resistance Band Group | Experimental | Other: Resistance Band Ankle RehabilitationEach session, patients completed resistance training using a resistance band in 4 directions of ankle motion (plantarflexion, dorsiflexion, inversion and eversion). Patients would complete 3 sets of 10 repetitions during each session. Every 3 sessions, the band resistance would increase. |
| Biomechanical Ankle Platform System | Experimental | Other: Biomechanical Ankle Platform System RehabilitationThe Biomechanical Ankle Platform System board is an oval shaped board that utilizes a half-sphere on the bottom of the board to allow the patient to train on an unstable surface. A one legged stance on their involved limb was performed on the Biomechanical Ankle Platform System board while clockwise and counterclockwise circles were completed. The initial rotation of direction was selected by the patient and changed every 10 seconds of the 40-second trial. Five 40-second trials were completed with 1-minute rest intervals in between the trials. Progression was determined by the supervising clinician and was based on the patient's ability to make smooth transitions between direction changes and completion of smooth circular rotations in both directions. |
| Combination Group | Experimental | Other: Combination RehabilitationPatients completing the combination protocol completed both the resistance band and Biomechanical Ankle Platform System board protocols during each session. The order of exercise completion was counterbalanced for each session. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- active for at least 1.5 hours a week, a history of at least 1 significant ankle sprain that required medical intervention, repeated symptoms of pain, swelling, weakness, instability, and repeated episodes of "giving way".
Key exclusion criteria (1 listed)
- presence of any current lower extremity injury (diagnosed by a medical professional within last 3 months with present symptoms), previous surgery to either leg, diagnosed ankle sprain within the past 6 weeks, history of ankle fractures and/or dislocations.
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 |
|---|---|---|
| Resistance Band Ankle RehabilitationResistance Band - uses a tension band to provide resistance during ankle motion | Other | Resistance Band Group |
| Biomechanical Ankle Platform System RehabilitationBiomechanical Ankle Platform System Board Group - uses different levels of half spheres to increase the amount of motion allowed at the ankle. | Other | Biomechanical Ankle Platform System |
| Combination RehabilitationCombination Group - includes both the resistance band and Biomechanical Ankle Platform System programs. | Other | Combination Group |
Primary outcome
Static Balance Assessments
Time frame: 4 weeks
Static Balance Clinical Tests
Functional Balance Assessments
Time frame: 4 weeks
Functional Balance Clinical Tests
Patient Self-reported Outcomes
Time frame: 4 to 12 weeks
Subjective Patient Reported Outcome Questionnaires
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 15 Oct 2018.
- Background: PubMed 17092927Leininger RE, Knox CL, Comstock RD. Epidemiology of 1.6 million pediatric soccer-related injuries presenting to US emergency departments from 1990 to 2003. Am J Sports Med. 2007 Feb;35(2):288-93. doi: 10.1177/0363546506294060. Epub 2006 Nov 7.
- Background: PubMed 20926721Waterman BR, Owens BD, Davey S, Zacchilli MA, Belmont PJ Jr. The epidemiology of ankle sprains in the United States. J Bone Joint Surg Am. 2010 Oct 6;92(13):2279-84. doi: 10.2106/JBJS.I.01537.
- Background: PubMed 15728682Anandacoomarasamy A, Barnsley L. Long term outcomes of inversion ankle injuries. Br J Sports Med. 2005 Mar;39(3):e14; discussion e14. doi: 10.1136/bjsm.2004.011676.
- Background: PubMed 12937557Hertel J. Functional Anatomy, Pathomechanics, and Pathophysiology of Lateral Ankle Instability. J Athl Train. 2002 Dec;37(4):364-375.
- Background: PubMed 21391798Hiller CE, Kilbreath SL, Refshauge KM. Chronic ankle instability: evolution of the model. J Athl Train. 2011 Mar-Apr;46(2):133-41. doi: 10.4085/1062-6050-46.2.133.
- Background: PubMed 23902805Gribble PA, Delahunt E, Bleakley C, Caulfield B, Docherty CL, Fourchet F, Fong D, Hertel J, Hiller C, Kaminski TW, McKeon PO, Refshauge KM, van der Wees P, Vicenzino B, Wikstrom EA. Selection criteria for patients with chronic ankle instability in controlled research: a position statement of the International Ankle Consortium. J Orthop Sports Phys Ther. 2013 Aug;43(8):585-91. doi: 10.2519/jospt.2013.0303. Epub 2013 Jul 31.
- Background: PubMed 23580392Wikstrom EA, Hubbard-Turner T, McKeon PO. Understanding and treating lateral ankle sprains and their consequences: a constraints-based approach. Sports Med. 2013 Jun;43(6):385-93. doi: 10.1007/s40279-013-0043-z.
- Background: PubMed 429402Harrington KD. Degenerative arthritis of the ankle secondary to long-standing lateral ligament instability. J Bone Joint Surg Am. 1979 Apr;61(3):354-61.
- Background: PubMed 12016082Hintermann B, Boss A, Schafer D. Arthroscopic findings in patients with chronic ankle instability. Am J Sports Med. 2002 May-Jun;30(3):402-9. doi: 10.1177/03635465020300031601.
- Background: PubMed 14767703Hirose K, Murakami G, Minowa T, Kura H, Yamashita T. Lateral ligament injury of the ankle and associated articular cartilage degeneration in the talocrural joint: anatomic study using elderly cadavers. J Orthop Sci. 2004;9(1):37-43. doi: 10.1007/s00776-003-0732-9.
- Background: PubMed 19950287Kotlarz H, Gunnarsson CL, Fang H, Rizzo JA. Insurer and out-of-pocket costs of osteoarthritis in the US: evidence from national survey data. Arthritis Rheum. 2009 Dec;60(12):3546-53. doi: 10.1002/art.24984.
- Background: PubMed 7734241Verhagen RA, de Keizer G, van Dijk CN. Long-term follow-up of inversion trauma of the ankle. Arch Orthop Trauma Surg. 1995;114(2):92-6. doi: 10.1007/BF00422833.
- Individual participant dataSharing planned: No. No individual participant data is planned to be shared with other researchers.
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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.
Benjamin M Goerger, PhD study director
Georgia State University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Band Ankle Rehabilitation, Biomechanical Ankle Platform System Rehabilitation and Combination Rehabilitation in people with Chronic Ankle Instability and Ankle Sprains, run by Georgia State University at 7 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 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 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
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?
Static Balance Assessments (time frame: 4 weeks). 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 NCT03447652, which also lists 104 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 15 Oct 2018.