Functional DeficitsNCT02945943
Effects of Mobilization in Conjunction With Therapeutic Exercise in Participants With a History of Ankle Sprain
A study testing High Velocity Low Amplitude mobilization and Exercise Protocol in people with Functional Deficits and Manipulation, run by Shenandoah University at 1 site in United States.
Trial summary
Our purpose was to examine the combined effects of thrust mobilization of the proximal and distal ankle joints in conjunction with a six-week rehabilitation program on ankle function in subjects reporting chronic ankle instability (CAI). Read more about this study
- Who is it for?
- Ages 16 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Deficits, Manipulation, Rehabilitation
- 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
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Oct 2013
- 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
- 16 to 35 years old age
- Self-reported history of an ankle sprain
- Reports of "giving way" or a "loose" ankle within the past 6 months and/or decrease in functional status as compared to the uninvolved ankle
Who cannot join
- Lower extremity injury within the past 3 months
- History of vestibular dysfunction, neuromuscular diagnosis, mental illness, or if the participant was currently participating in another supervised rehabilitation program for the involved ankle.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shenandoah University Division of Physical Therapy
Winchester, Virginia, 22601
About this study
Official title: Effects of a Six-week Rehabilitation Program in Conjunction With Thrust Mobilization on Lower Extremity Function in Subjects Reporting Chronic Ankle Instability
Our purpose was to examine the combined effects of thrust mobilization of the proximal and distal ankle joints in conjunction with a six-week rehabilitation program on ankle function 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. There is no research supporting the combined effects of thrust mobilization and exercise on function in this population.
Inclusion and exclusion criterion were established and a convenience sample was performed. 19 subjects were randomized into the exercise only or mobilization (experimental) and exercise group. Both groups underwent 12 supervised training sessions across a six-week period. The mobilization (experimental) group also received high-velocity-low-amplitude (HVLA) thrust mobilizations at the talocrural, proximal, and distal tibiofibular joints prior to the first three treatment sessions.
An examiner blinded to involved limb and group allocation performed a baseline and six-week follow-up examination of muscle strength, joint mobility, range of motion, and/or functional performance. The participants completed subjective outcome measures at baseline, 2 weeks, 4 weeks, and finally at 6 weeks including the Functional Ankle Disability Index (FADI), FADI-Sport, and the Ankle Joint Functional Assessment Tool (AJFAT). Participants also completed baseline and a 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 completed this protocol twice a week, for six weeks. Treatment sessions lasted approximately 30 minutes. Participants were individually progressed on particular exercises if zero errors were observed. In addition, all participants were given a home exercise program (HEP) to complete every day of the week excluding treatment days.
The mobilization (experimental) group received HVLA thrust mobilizations at the three joints stated above for the first three sessions prior to completing the exercise protocol. Each mobilization was performed one time at each joint. The order of joint mobilizations was randomized prior to administering.
Data analysis was performed using International Business Machines Statistical Package for the Social Sciences (SPSS) version (22). Alpha level was set p<0.05. Separate 2 x 2 repeated measures analysis of variance (ANOVA) were used to assess changes in the FADI, FADI-Sport, figure-of-8 hop test, side hop test, and three directions of the SEBT.
- Conditions
- Functional Deficits, Manipulation, Rehabilitation
- Being tested
- High Velocity Low Amplitude mobilization, Exercise Protocol
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 were performed one time at each joint, prior to completing the exercise protocol during the first three treatment sessions.
Exercise ProtocolOther
Also called Control
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 manipulated included proximal tibiofibular, the distal tibiofibular, and talocrural joints and were 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 began the test on either side of a demarcated 5-meter distance. While standing on the involved ankle, the participant was instructed to "hop on one foot, as fast as you can," twice around the figure 8. Two trials were 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 were then instructed to "hop on one foot, as fast as you can," laterally and then back to the starting position. This was counted as two repetitions and 10 repetitions were performed. If the participant landed on or between the lines, this repetition was not counted and they continued until 10 good repetitions were completed. Participants performed two trials and the fastest time was recorded.
Measured: Baseline and 6 weeks
Change in baseline Star Excursion Balance Test (SEBT) at 6 weeks.
Each participant was 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 Functional Ankle Disability Index (FADI) at 6 weeks.
The FADI is a 26-item tool that is designed to assess functional limitations related to foot and ankle conditions. Each item is scored from 0 (unable to do) to 4 (no difficulty at all) and has total point value of 104 points.
Measured: Baseline, 2 week, 4 weeks, 6 weeks
Change in baseline Functional Ankle Disability Index (FADI)- Sport at 6 weeks.
The FADI-Sport is an 8-item tool that is a sub-scale of the FADI. Each item is scored with from 0 (unable to do) to 4 with a total point value of 32 points, reported as a percent value.
Measured: Baseline, 2 week, 4 weeks, 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, 2 week, 4 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startFeb 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Functional DeficitsStudies 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenandoah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cameron Jones, Shenandoah University
- Investigators
- Cameron R Jones, DPT, Principal investigator, Shenandoah University Division of Physical TherapySheri Hale, PhD, PT, Principal investigator, Shenandoah University Division of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945943
- Sponsor's protocol ID
- 12-1627
- Status last verified
- Oct 2016
- First submitted
- 24 Oct 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
- Individual data sharing
- Yes: Data from subjective and objective outcome measures from all participants obtained prior to and after intervention have been analyzed.
Publications
McKeon 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 18799992Waterman 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 20926721Hertel J. Sensorimotor deficits with ankle sprains and chronic ankle instability. Clin Sports Med. 2008 Jul;27(3):353-70, vii. doi: 10.1016/j.csm.2008.03.006.
PubMed 18503872Wikstrom EA, Hubbard TJ. Talar positional fault in persons with chronic ankle instability. Arch Phys Med Rehabil. 2010 Aug;91(8):1267-71. doi: 10.1016/j.apmr.2010.04.022.
PubMed 20684909Hale 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 17612356Hupperets MD, Verhagen EA, van Mechelen W. Effect of unsupervised home based proprioceptive training on recurrences of ankle sprain: randomised controlled trial. BMJ. 2009 Jul 9;339:b2684. doi: 10.1136/bmj.b2684.
PubMed 19589822Beazell 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 22333567Hubbard TJ, Hertel J. Anterior positional fault of the fibula after sub-acute lateral ankle sprains. Man Ther. 2008 Feb;13(1):63-7. doi: 10.1016/j.math.2006.09.008. Epub 2006 Dec 26.
PubMed 17188923Denegar CR, Hertel J, Fonseca J. The effect of lateral ankle sprain on dorsiflexion range of motion, posterior talar glide, and joint laxity. J Orthop Sports Phys Ther. 2002 Apr;32(4):166-73. doi: 10.2519/jospt.2002.32.4.166.
PubMed 11949665Grindstaff TL, Beazell JR, Sauer LD, Magrum EM, Ingersoll CD, Hertel J. Immediate effects of a tibiofibular joint manipulation on lower extremity H-reflex measurements in individuals with chronic ankle instability. J Electromyogr Kinesiol. 2011 Aug;21(4):652-8. doi: 10.1016/j.jelekin.2011.03.011. Epub 2011 May 4.
PubMed 21546263Whitman JM, Childs JD, Walker V. The use of manipulation in a patient with an ankle sprain injury not responding to conventional management: a case report. Man Ther. 2005 Aug;10(3):224-31. doi: 10.1016/j.math.2004.10.003. Epub 2005 Jan 21. No abstract available.
PubMed 16038858Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21.
PubMed 19027342
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Six-week Rehabilitation Program in Conjunction With Thrust Mobilization on Lower Extremity Function in Subjects Reporting Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT02945943
- Acronym / sponsor ID
- 12-1627
- Conditions
- Functional Deficits, Manipulation, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Shenandoah UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our purpose was to examine the combined effects of thrust mobilization of the proximal and distal ankle joints in conjunction with a six-week rehabilitation program on ankle function 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. There is no research supporting the combined effects of thrust mobilization and exercise on function in this population.
Inclusion and exclusion criterion were established and a convenience sample was performed. 19 subjects were randomized into the exercise only or mobilization (experimental) and exercise group. Both groups underwent 12 supervised training sessions across a six-week period. The mobilization (experimental) group also received high-velocity-low-amplitude (HVLA) thrust mobilizations at the talocrural, proximal, and distal tibiofibular joints prior to the first three treatment sessions.
An examiner blinded to involved limb and group allocation performed a baseline and six-week follow-up examination of muscle strength, joint mobility, range of motion, and/or functional performance. The participants completed subjective outcome measures at baseline, 2 weeks, 4 weeks, and finally at 6 weeks including the Functional Ankle Disability Index (FADI), FADI-Sport, and the Ankle Joint Functional Assessment Tool (AJFAT). Participants also completed baseline and a 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 completed this protocol twice a week, for six weeks. Treatment sessions lasted approximately 30 minutes. Participants were individually progressed on particular exercises if zero errors were observed. In addition, all participants were given a home exercise program (HEP) to complete every day of the week excluding treatment days.
The mobilization (experimental) group received HVLA thrust mobilizations at the three joints stated above for the first three sessions prior to completing the exercise protocol. Each mobilization was performed one time at each joint. The order of joint mobilizations was randomized prior to administering.
Data analysis was performed using International Business Machines Statistical Package for the Social Sciences (SPSS) version (22). Alpha level was set p<0.05. Separate 2 x 2 repeated measures analysis of variance (ANOVA) were used to assess changes in the FADI, FADI-Sport, 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 manipulated included proximal tibiofibular, the distal tibiofibular, and talocrural joints and were 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
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 16 to 35 years old age
- Self-reported history of an ankle sprain
- Reports of "giving way" or a "loose" ankle within the past 6 months and/or decrease in functional status as compared to the uninvolved ankle
Key exclusion criteria (2 listed)
- Lower extremity injury within the past 3 months
- History of vestibular dysfunction, neuromuscular diagnosis, mental illness, or if the participant was currently participating in another supervised rehabilitation program for the involved ankle.
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 were performed one time at each joint, prior to completing the exercise protocol during the first three treatment sessions. | Other | Mobilization |
| Exercise ProtocolAlso: ControlThis 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 began the test on either side of a demarcated 5-meter distance. While standing on the involved ankle, the participant was instructed to "hop on one foot, as fast as you can," twice around the figure 8. Two trials were 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 were then instructed to "hop on one foot, as fast as you can," laterally and then back to the starting position. This was counted as two repetitions and 10 repetitions were performed. If the participant landed on or between the lines, this repetition was not counted and they continued until 10 good repetitions were completed. Participants performed two trials and the fastest time was recorded.
Change in baseline Star Excursion Balance Test (SEBT) at 6 weeks.
Time frame: Baseline and 6 weeks
Each participant was asked to maintain single-limb stance, with hands on their hips, while reaching in anterior, posteromedial, and posterolateral directions.
Change in baseline Functional Ankle Disability Index (FADI) at 6 weeks.
Time frame: Baseline, 2 week, 4 weeks, 6 weeks
The FADI is a 26-item tool that is designed to assess functional limitations related to foot and ankle conditions. Each item is scored from 0 (unable to do) to 4 (no difficulty at all) and has total point value of 104 points.
Change in baseline Functional Ankle Disability Index (FADI)- Sport at 6 weeks.
Time frame: Baseline, 2 week, 4 weeks, 6 weeks
The FADI-Sport is an 8-item tool that is a sub-scale of the FADI. Each item is scored with from 0 (unable to do) to 4 with a total point value of 32 points, reported as a percent value.
Change in baseline Ankle Joint Functional Assessment Tool (AJFAT) at 6 weeks.
Time frame: Baseline, 2 week, 4 weeks, 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.
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 26 Oct 2016.
- 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 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 18503872Hertel J. Sensorimotor deficits with ankle sprains and chronic ankle instability. Clin Sports Med. 2008 Jul;27(3):353-70, vii. doi: 10.1016/j.csm.2008.03.006.
- Background: PubMed 20684909Wikstrom EA, Hubbard TJ. Talar positional fault in persons with chronic ankle instability. Arch Phys Med Rehabil. 2010 Aug;91(8):1267-71. doi: 10.1016/j.apmr.2010.04.022.
- 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 19589822Hupperets MD, Verhagen EA, van Mechelen W. Effect of unsupervised home based proprioceptive training on recurrences of ankle sprain: randomised controlled trial. BMJ. 2009 Jul 9;339:b2684. doi: 10.1136/bmj.b2684.
- 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.
- Background: PubMed 17188923Hubbard TJ, Hertel J. Anterior positional fault of the fibula after sub-acute lateral ankle sprains. Man Ther. 2008 Feb;13(1):63-7. doi: 10.1016/j.math.2006.09.008. Epub 2006 Dec 26.
- Background: PubMed 11949665Denegar CR, Hertel J, Fonseca J. The effect of lateral ankle sprain on dorsiflexion range of motion, posterior talar glide, and joint laxity. J Orthop Sports Phys Ther. 2002 Apr;32(4):166-73. doi: 10.2519/jospt.2002.32.4.166.
- Background: PubMed 21546263Grindstaff TL, Beazell JR, Sauer LD, Magrum EM, Ingersoll CD, Hertel J. Immediate effects of a tibiofibular joint manipulation on lower extremity H-reflex measurements in individuals with chronic ankle instability. J Electromyogr Kinesiol. 2011 Aug;21(4):652-8. doi: 10.1016/j.jelekin.2011.03.011. Epub 2011 May 4.
- Background: PubMed 16038858Whitman JM, Childs JD, Walker V. The use of manipulation in a patient with an ankle sprain injury not responding to conventional management: a case report. Man Ther. 2005 Aug;10(3):224-31. doi: 10.1016/j.math.2004.10.003. Epub 2005 Jan 21. No abstract available.
- Background: PubMed 19027342Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21.
- Individual participant dataSharing planned: Yes. Data from subjective and objective outcome measures from all participants obtained prior to and after intervention have been analyzed.
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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 R Jones, DPT principal investigator
Shenandoah University Division of Physical Therapy
Sheri Hale, PhD, PT principal investigator
Shenandoah University Division of Physical Therapy
1 site 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 Functional Deficits and Manipulation, run by Shenandoah 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 3 inclusion and 2 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 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Change in baseline Figure-of-8 hop test at 6 weeks. (time frame: Baseline and 6 weeks). The study lists 6 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 NCT02945943, which also lists 12 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 26 Oct 2016.