Chronic Ankle InstabilityPhase 2STARSNCT01541657
Sensory-Targeted Ankle Rehabilitation Strategies (STARS)
A Phase 2 study testing Ankle Joint Mobilization, Foot Massage and Calf Stretching in people with Chronic Ankle Instability, run by Joel Thompson at 2 sites in United States.
Trial summary
The purpose of this study is to determine the effect of 3 types of sensory-targeted rehabilitation interventions on subjective and objective measures of function for those with chronic ankle instability. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Chronic Ankle Instability
- What is being tested?
- Ankle Joint Mobilization, Foot Massage and Calf Stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2011to Apr 2014
- Phase
- Phase 2
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female 18-45 years of age
- History of ankle sprain with at least two episodes of "giving way" within the past six months
- Score of ≥ 5 on the Ankle Instability Instrument (AII)
- Score of ≤ 90% on the Foot and Ankle Ability Measure (FAAM)- Activity of Daily Living (ADL) Subscale
- Score of ≤ 80% on the FAAM-Sport Subscale.
Who cannot join
- Younger than 18 or older than 45 years
- No history of ankle sprain or episodes of "giving way" in the past six months
- Score of ≤ 5 on the Ankle Instability Instrument (AII)
- Score of ≥ 90% on the FAAM-ADL
- Score of ≥ 80% on the FAAM-S.
- An acute ankle sprain within the past 6 weeks.
Show all 9Show fewer
- Previous history of lower extremity surgery with internal derangements, reconstructions, or repair
- Lower extremity injury within the past 6 months (other than ankle sprains)
- Presence of balance deficits or conditions known to affect balance as noted on the Balance Questionnaire including diabetes and/or vertigo.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina Charlotte
Charlotte, North Carolina, 28223
Ithaca College
Ithaca, New York, 14850
About this study
Official title: Sensory-Targeted Ankle Rehabilitation Strategies
The purpose of this study is to determine the effect of 3 types of sensory-targeted rehabilitation interventions on subjective and objective measures of function for those with chronic ankle instability. The investigators hypothesize that subjective and objective measures of function including self-reported disability, balance, and range of motion will improve after 2-weeks of sensory-targeted interventions.
Read the detailed description
The purpose of this study is to determine the effect of 3 types of sensory-targeted rehabilitation interventions on subjective and objective measures of function for those with chronic ankle instability. If a potential participant is deemed eligible for participation and consents to participate, he/she undergo a pretest session in which balance, gait, and range of motion will be assessed. The participant will then be randomized into one of the 4 treatment groups and undergo the first treatment which takes approximately 5 minutes. After completion of the first treatment, the participant will be immediately retested on the balance, gait, and range of motion measures. Upon completion of testing on the first day, participants in the treatment groups will be asked to return for 5 more treatments over the course of 2 weeks. Upon completion of the treatments, each participant will be tested on their balance, gait, and range of motion again. Then, after 1 month, each participant will be contacted to do a self-reported function follow-up visit in which he/she will be asked to report how stable and functional his/her ankle has been over the past month.
- Conditions
- Chronic Ankle Instability
- Being tested
- Ankle Joint Mobilization, Foot Massage, Calf Stretching
- Keywords
- Ankle Instability, Sensorimotor Control, Sensory, Postural Control, Balance, Gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle Joint MobilizationOther
Also called Ankle Range of Motion, Joint Manipulation
The posterior ankle mobilization treatment is a manual therapy technique that consists of gently gliding your ankle in the backward direction through a pain free range of motion. This is a common therapy technique used by athletic trainers for the treatment of ankle sprains. The objective of this therapy technique is to glide the ankle into the area which restricts range of motion and gently stretch the restricted area. To begin this treatment, a certified athletic trainer with experience in applying this therapy technique will provide mild traction to the ankle joint to lightly distract the bones of the ankle joint. The athletic trainer will then apply two sets of joint mobilizations which will each last 2 minutes. Each repetition will consist of gently gliding the ankle joint in the backward direction until an area of restriction is reached. The athletic trainer will push into the restriction and then glide the ankle back to the starting position.
Foot MassageOther
Also called Plantar Massage, Plantar Stimulation, Foot Rub
The foot massage treatment is a manual therapy technique that consists of gently rubbing the bottom of your feet with both hands like kneading dough. To begin the treatment, you will be asked to lie comfortably on a treatment table you're your feet hanging slightly off the edge. The athletic trainer with experience in applying this therapy will place his hands on the bottom of your foot and begin to massage your feet from your toes down to your heel. The athletic trainer will perform 2 sets of 2 minutes of massage with 1 minute rest in between sets.
Calf StretchingOther
Also called Muscle Stretch, Flexibility
The calf stretching treatment is a technique that is commonly used in sports and rehabilitation. You will be asked to place your foot on a slant board located next to a wall with your heel positioned below your toes on the slant board. You will be asked to lean towards the wall until you feel tension in your calf muscles that feels like a good stretch. You will perform 2 sets of 3 stretches that are held for 30 seconds each. Between each stretch, you will rest for 10 seconds. Between each set, you will rest for 1 minute.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | This group will only take part in the data collection sessions. After the first testing session (Pre-Intervention) the participants will be asked to rest comfortably for 5 minutes. After the rest period, they will be reassessed. Upon completion of the second testing, they will be asked to maintain the same lifestyle over the course of 2 weeks. They will then be asked to return to the lab after the 2 week interval to be tested again. Upon completion of the third testing session, they will be contacted after 1 month to complete the self-reported function questionnaires. |
| Ankle Joint Mobilization | Experimental | The posterior ankle mobilization treatment is a manual therapy technique that consists of gently gliding your ankle in the backward direction through a pain free range of motion. This is a common therapy technique used by athletic trainers for the treatment of ankle sprains. The objective of this therapy technique is to glide the ankle into the area which restricts range of motion and gently stretch the restricted area. To begin this treatment, a certified athletic trainer with experience in applying this therapy technique will provide mild traction to the ankle joint to lightly distract the bones of the ankle joint. The athletic trainer will then apply two sets of joint mobilizations which will each last 2 minutes. Each repetition will consist of gently gliding the ankle joint in the backward direction until an area of restriction is reached. The athletic trainer will push into the restriction and then glide the ankle back to the starting position. Receives: Other: Ankle Joint Mobilization |
| Foot Massage | Experimental | The foot massage treatment is a manual therapy technique that consists of gently rubbing the bottom of your feet with both hands like kneading dough. To begin the treatment, you will be asked to lie comfortably on a treatment table you're your feet hanging slightly off the edge. The athletic trainer with experience in applying this therapy will place his hands on the bottom of your foot and begin to massage your feet from your toes down to your heel. The athletic trainer will perform 2 sets of 2 minutes of massage with 1 minute rest in between sets. Receives: Other: Foot Massage |
| Calf Stretching | Experimental | The calf stretching treatment is a technique that is commonly used in sports and rehabilitation. You will be asked to place your foot on a slant board located next to a wall with your heel positioned below your toes on the slant board. You will be asked to lean towards the wall until you feel tension in your calf muscles that feels like a good stretch. You will perform 2 sets of 3 stretches that are held for 30 seconds each. Between each stretch, you will rest for 10 seconds. Between each set, you will rest for 1 minute. Receives: Other: Calf Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot and Ankle Ability Measure
The Foot and Ankle Ability Measure (FAAM) is a questionnaire used to quantify the amount of self-reported disability a person experiences because of chronic ankle instability. It has two sections which will be used to assess disability associated with activities of daily living and sport activities.
Measured: This will be assessed at 3 time points: Change from Pre-intervention to Post-Intervention, change from Pre-Intervention to 1-month Post-Intervention
Gait Initiation
Gait initiation is a laboratory technique that involves the use of a force plate. Participants are asked to stand on the force plate with feet and step off the force plate with either the right or left foot. The size of the weight shifts a participant makes while taking a step are evaluated using the force plate. Each participant will complete 5 trials stepping with each leg for every time point.
Measured: This will be assessed at 3 time points: Change from Pre-Intervention to Immediately Post Day 1 Intervention, and Change from Pre-Intervention to Post-Intervention
Time to Boundary
Time to Boundary is a balance measurement in which a person maintains single leg stance on a force plate for 10 seconds. This measurement technique evaluates the amount of time a person has to make corrections to maintain balance. Each participant will perform 12 trials for each time point. Each leg will be tested 6 times, 3 with eyes open and 3 with eyes closed.
Measured: This will be assessed at 3 time points: Change from Pre-Intervention to Immediately Post Day 1 Intervention, and Change from Pre-Intervention to Post-Intervention
Weight-bearing Lunge Test
The Weight-bearing Lunge Test is a measure of ankle dorsiflexion range of motion while the participant stands in front of a wall.
Measured: This will be assessed at 3 time points: Change from Pre-Intervention to Immediately Post Day 1 Intervention, and Change from Pre-Intervention to Post-Intervention
Cutaneous Sensation
Each participant will have the sensitivity of the bottom of his/her feet assessed. The investigators will use a set of monofilaments (similar to fishing line) to see how small of a monofilament can be detected when the investigator touches the bottom of his or her foot. Participants will be asked to close their eyes during testing.
Measured: This will be assessed at 3 time points: Change from Pre-Intervention to Immediately Post Day 1 Intervention, and Change from Pre-Intervention to Post-Intervention
Single Limb Balance Error Scoring System Assessment
Each participant will be asked to balance on one leg for 20 seconds with eyes closed while standing on the floor. During the test, the investigator will count how many times the participant deviates from the target position (standing on one leg with hands on hips).
Measured: This will be assessed at 3 time points: Change from Pre-Intervention to Immediately Post Day 1 Intervention, and Change from Pre-Intervention to Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startDec 2011
- Primary completionApr 2014
- Study completionApr 2014
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joel Thompson
- Sponsor type
- University, hospital or other
- Collaborators
- Ithaca College, University of North Carolina, Charlotte, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor-investigator, Joel Thompson, University of Kentucky
- Investigators
- Patrick O McKeon, PhD, Principal investigator, Ithaca CollegeErik A Wikstrom, PhD, Principal investigator, University of North Carolina, Charlotte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541657
- Sponsor's protocol ID
- R03AR06156101
- Acronym
- STARS
- Status last verified
- Jan 2018
- First submitted
- 20 Feb 2012
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McKeon PO, Wikstrom EA. The effect of sensory-targeted ankle rehabilitation strategies on single-leg center of pressure elements in those with chronic ankle instability: A randomized clinical trial. J Sci Med Sport. 2019 Mar;22(3):288-293. doi: 10.1016/j.jsams.2018.08.017. Epub 2018 Sep 6.
PubMed 30244979
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory-Targeted Ankle Rehabilitation Strategies
- ClinicalTrials.gov ID
- NCT01541657
- Acronym / sponsor ID
- STARS / R03AR06156101
- Conditions
- Chronic Ankle Instability
- Keywords
- Ankle Instability, Sensorimotor Control, Sensory, Postural Control, Balance, Gait
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Joel ThompsonUniversity, hospital or other
- Collaborators
- Ithaca College, University of North Carolina, Charlotte, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Dec 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 1 Mar 2012 (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.
The purpose of this study is to determine the effect of 3 types of sensory-targeted rehabilitation interventions on subjective and objective measures of function for those with chronic ankle instability. The investigators hypothesize that subjective and objective measures of function including self-reported disability, balance, and range of motion will improve after 2-weeks of sensory-targeted interventions.
Detailed description
The purpose of this study is to determine the effect of 3 types of sensory-targeted rehabilitation interventions on subjective and objective measures of function for those with chronic ankle instability. If a potential participant is deemed eligible for participation and consents to participate, he/she undergo a pretest session in which balance, gait, and range of motion will be assessed. The participant will then be randomized into one of the 4 treatment groups and undergo the first treatment which takes approximately 5 minutes. After completion of the first treatment, the participant will be immediately retested on the balance, gait, and range of motion measures. Upon completion of testing on the first day, participants in the treatment groups will be asked to return for 5 more treatments over the course of 2 weeks. Upon completion of the treatments, each participant will be tested on their balance, gait, and range of motion again. Then, after 1 month, each participant will be contacted to do a self-reported function follow-up visit in which he/she will be asked to report how stable and functional his/her ankle has been over the past month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –This group will only take part in the data collection sessions. After the first testing session (Pre-Intervention) the participants will be asked to rest comfortably for 5 minutes. After the rest period, they will be reassessed. Upon completion of the second testing, they will be asked to maintain the same lifestyle over the course of 2 weeks. They will then be asked to return to the lab after the 2 week interval to be tested again. Upon completion of the third testing session, they will be contacted after 1 month to complete the self-reported function questionnaires. |
| Ankle Joint Mobilization | Experimental | Other: Ankle Joint MobilizationThe posterior ankle mobilization treatment is a manual therapy technique that consists of gently gliding your ankle in the backward direction through a pain free range of motion. This is a common therapy technique used by athletic trainers for the treatment of ankle sprains. The objective of this therapy technique is to glide the ankle into the area which restricts range of motion and gently stretch the restricted area. To begin this treatment, a certified athletic trainer with experience in applying this therapy technique will provide mild traction to the ankle joint to lightly distract the bones of the ankle joint. The athletic trainer will then apply two sets of joint mobilizations which will each last 2 minutes. Each repetition will consist of gently gliding the ankle joint in the backward direction until an area of restriction is reached. The athletic trainer will push into the restriction and then glide the ankle back to the starting position. |
| Foot Massage | Experimental | Other: Foot MassageThe foot massage treatment is a manual therapy technique that consists of gently rubbing the bottom of your feet with both hands like kneading dough. To begin the treatment, you will be asked to lie comfortably on a treatment table you're your feet hanging slightly off the edge. The athletic trainer with experience in applying this therapy will place his hands on the bottom of your foot and begin to massage your feet from your toes down to your heel. The athletic trainer will perform 2 sets of 2 minutes of massage with 1 minute rest in between sets. |
| Calf Stretching | Experimental | Other: Calf StretchingThe calf stretching treatment is a technique that is commonly used in sports and rehabilitation. You will be asked to place your foot on a slant board located next to a wall with your heel positioned below your toes on the slant board. You will be asked to lean towards the wall until you feel tension in your calf muscles that feels like a good stretch. You will perform 2 sets of 3 stretches that are held for 30 seconds each. Between each stretch, you will rest for 10 seconds. Between each set, you will rest for 1 minute. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female 18-45 years of age
- History of ankle sprain with at least two episodes of "giving way" within the past six months
- Score of ≥ 5 on the Ankle Instability Instrument (AII)
- Score of ≤ 90% on the Foot and Ankle Ability Measure (FAAM)- Activity of Daily Living (ADL) Subscale
- Score of ≤ 80% on the FAAM-Sport Subscale.
Key exclusion criteria (9 listed)
- Younger than 18 or older than 45 years
- No history of ankle sprain or episodes of "giving way" in the past six months
- Score of ≤ 5 on the Ankle Instability Instrument (AII)
- Score of ≥ 90% on the FAAM-ADL
- Score of ≥ 80% on the FAAM-S.
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 |
|---|---|---|
| Ankle Joint MobilizationAlso: Ankle Range of Motion, Joint ManipulationThe posterior ankle mobilization treatment is a manual therapy technique that consists of gently gliding your ankle in the backward direction through a pain free range of motion. This is a common therapy technique used by athletic trainers for the treatment of ankle sprains. The objective of this therapy technique is to glide the ankle into the area which restricts range of motion and gently stretch the restricted area. To begin this treatment, a certified athletic trainer with experience in applying this therapy technique will provide mild traction to the ankle joint to lightly distract the bones of the ankle joint. The athletic trainer will then apply two sets of joint mobilizations which will each last 2 minutes. Each repetition will consist of gently gliding the ankle joint in the backward direction until an area of restriction is reached. The athletic trainer will push into the restriction and then glide the ankle back to the starting position. | Other | Ankle Joint Mobilization |
| Foot MassageAlso: Plantar Massage, Plantar Stimulation, Foot RubThe foot massage treatment is a manual therapy technique that consists of gently rubbing the bottom of your feet with both hands like kneading dough. To begin the treatment, you will be asked to lie comfortably on a treatment table you're your feet hanging slightly off the edge. The athletic trainer with experience in applying this therapy will place his hands on the bottom of your foot and begin to massage your feet from your toes down to your heel. The athletic trainer will perform 2 sets of 2 minutes of massage with 1 minute rest in between sets. | Other | Foot Massage |
| Calf StretchingAlso: Muscle Stretch, FlexibilityThe calf stretching treatment is a technique that is commonly used in sports and rehabilitation. You will be asked to place your foot on a slant board located next to a wall with your heel positioned below your toes on the slant board. You will be asked to lean towards the wall until you feel tension in your calf muscles that feels like a good stretch. You will perform 2 sets of 3 stretches that are held for 30 seconds each. Between each stretch, you will rest for 10 seconds. Between each set, you will rest for 1 minute. | Other | Calf Stretching |
Primary outcome
Foot and Ankle Ability Measure
Time frame: This will be assessed at 3 time points: Change from Pre-intervention to Post-Intervention, change from Pre-Intervention to 1-month Post-Intervention
The Foot and Ankle Ability Measure (FAAM) is a questionnaire used to quantify the amount of self-reported disability a person experiences because of chronic ankle instability. It has two sections which will be used to assess disability associated with activities of daily living and sport activities.
Gait Initiation
Time frame: This will be assessed at 3 time points: Change from Pre-Intervention to Immediately Post Day 1 Intervention, and Change from Pre-Intervention to Post-Intervention
Gait initiation is a laboratory technique that involves the use of a force plate. Participants are asked to stand on the force plate with feet and step off the force plate with either the right or left foot. The size of the weight shifts a participant makes while taking a step are evaluated using the force plate. Each participant will complete 5 trials stepping with each leg for every time point.
Time to Boundary
Time frame: This will be assessed at 3 time points: Change from Pre-Intervention to Immediately Post Day 1 Intervention, and Change from Pre-Intervention to Post-Intervention
Time to Boundary is a balance measurement in which a person maintains single leg stance on a force plate for 10 seconds. This measurement technique evaluates the amount of time a person has to make corrections to maintain balance. Each participant will perform 12 trials for each time point. Each leg will be tested 6 times, 3 with eyes open and 3 with eyes closed.
Weight-bearing Lunge Test
Time frame: This will be assessed at 3 time points: Change from Pre-Intervention to Immediately Post Day 1 Intervention, and Change from Pre-Intervention to Post-Intervention
The Weight-bearing Lunge Test is a measure of ankle dorsiflexion range of motion while the participant stands in front of a wall.
Cutaneous Sensation
Time frame: This will be assessed at 3 time points: Change from Pre-Intervention to Immediately Post Day 1 Intervention, and Change from Pre-Intervention to Post-Intervention
Each participant will have the sensitivity of the bottom of his/her feet assessed. The investigators will use a set of monofilaments (similar to fishing line) to see how small of a monofilament can be detected when the investigator touches the bottom of his or her foot. Participants will be asked to close their eyes during testing.
Single Limb Balance Error Scoring System Assessment
Time frame: This will be assessed at 3 time points: Change from Pre-Intervention to Immediately Post Day 1 Intervention, and Change from Pre-Intervention to Post-Intervention
Each participant will be asked to balance on one leg for 20 seconds with eyes closed while standing on the floor. During the test, the investigator will count how many times the participant deviates from the target position (standing on one leg with hands on hips).
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 Jan 2018.
- Derived from this study: PubMed 30244979McKeon PO, Wikstrom EA. The effect of sensory-targeted ankle rehabilitation strategies on single-leg center of pressure elements in those with chronic ankle instability: A randomized clinical trial. J Sci Med Sport. 2019 Mar;22(3):288-293. doi: 10.1016/j.jsams.2018.08.017. Epub 2018 Sep 6.
Related trials for Chronic Ankle Instability
Recruiting
Neurocognitive Enrichment During Functional Performance Testing in Chronic Ankle Instability
Chronic Ankle Instability, CAI
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Recruiting
Functional Biomechanical Analysis in Patients Who Underwent Lateral Ankle Ligament Repair With Augmentation
Chronic Lateral Ankle Instability
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
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.
Patrick O McKeon, PhD principal investigator
Ithaca College
Erik A Wikstrom, PhD principal investigator
University of North Carolina, Charlotte
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ankle Joint Mobilization, Foot Massage and Calf Stretching in people with Chronic Ankle Instability, run by Joel Thompson 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 5 inclusion and 9 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 Jan 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Foot and Ankle Ability Measure (time frame: This will be assessed at 3 time points: Change from Pre-intervention to Post-Intervention, change from Pre-Intervention to 1-month Post-Intervention). 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 NCT01541657, 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 26 Jan 2018.