Ankle SprainsNCT03918473
Effects of Mobilization Versus Manipulation on Function in Participants Reporting CAI
A study testing Mobilization with Movement and Thrust Mobilization in people with Ankle Sprains, run by Shenandoah University at 1 site in United States.
Trial summary
The investigator's purpose is to compare the effects of talocrural joint mobilization with movement versus thrust mobilization 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?
- Mobilization with Movement and Thrust Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2019to Dec 2020
- 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 (i.e., 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 (i.e., sprains, fractures) resulting in at least 1 interrupted day of desired physical activity
Trial locations and contacts
1 site in 1 country.
United States1 site
Shenandoah University
Winchester, Virginia, 22601
Cameron Bolton, DPT, 540-542-6540, cbolton16@su.edu
Sheri Hale, PhD, PT, 5405457240, shale2@su.edu
About this study
Official title: Effects of Mobilization Versus Manipulation on Function in Participants Reporting Chronic Ankle Instability
The investigator's purpose is to compare the effects of talocrural joint mobilization with movement versus thrust mobilization 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 comparing the effects of mobilization with movement (MWM) versus thrust mobilization (TM) directed at the talocrural joint on functional performance 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 MWM or TM group.
The MWM group will receive manual therapy with the following protocol: the participant will be relaxed and standing in a staggered stance with the involved foot on an eight inch step and both feet facing forward . The clinician will be positioned in front of the participant's leg and a non-elastic belt will be placed around the distal leg of the participant and the clinician's pelvis. The clinician will then apply a sustained posteroanterior glide to the tibia through the belt by leaning backwards, while stabilizing the fixed talus and forefoot with both hands. The participant will perform a slow lunge until the end range of motion without their heel lifting off the ground. The belt will be kept perpendicular to the tibia throughout the movement and 2 sets of 10 repetitions will be applied.
The talocrural joint TM will be a high velocity low amplitude manual therapy technique. This technique will be applied with the participant in the supine position on a plinth. The clinician grasps the foot with one hand with the fifth finger contacting the anterior surface of the ankle at the talus. The other hand reinforces the contact points and both thumbs are placed on the sole of the participant's foot. The clinician gives slight caudal traction focused on the talocrural joint with the ankle dorsiflexed and everted. The therapist then applies a high-velocity thrust distraction technique to the talocrural joint. Only one thrust will be applied and no audible cavitation is required. Each manual therapy technique will be performed once.
An examiner, who is blinded to involved limb and group allocation, will perform a baseline, immediate follow-up, and one-week follow-up examination of range of motion and functional performance. The participants will complete subjective outcome measures at baseline, immediately post intervention, and at 1 week post intervention including the Foot and Ankle Ability Measurement (FAAM), FAAM-Sport, and the Cumberland Ankle Instability Tool (CAIT). Participants will also complete baseline, immediate follow-up, and one-week follow up assessments of the Multiple Hop Test (MHT), three directions of the Star Excursion Balance test (SEBT), and weight bearing lunge test (WBLT).
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, CAIT, MHT, WBLT, and three directions of the SEBT.
- Conditions
- Ankle Sprains
- Being tested
- Mobilization with Movement, Thrust Mobilization
- Keywords
- Functional Performance, Manual Therapy
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilization with MovementOther
The MWM group will receive manual therapy with the following protocol: the participant will be relaxed and standing in a staggered stance with the involved foot on an eight-inch step and both feet facing forward. The clinician will be positioned in front of the participant's leg and a non-elastic belt will be placed around the distal leg of the participant and the clinician's pelvis. The clinician will then apply a sustained posteroanterior glide to the tibia through the belt by leaning backwards, while stabilizing the fixed talus and forefoot with both hands. The participant will perform a slow lunge until the end range of motion without their heel lifting off the ground. The belt will be kept perpendicular to the tibia throughout the movement and 2 sets of 10 repetitions will be applied.
Thrust MobilizationOther
The talocrural joint TM will be a high velocity low amplitude manual therapy technique. This technique will be applied with the participant in the supine position on a plinth. The clinician grasps the foot with one hand with the fifth finger contacting the anterior surface of the ankle at the talus. The other hand reinforces the contact points and both thumbs are placed on the sole of the participant's foot. The clinician gives slight caudal traction focused on the talocrural joint with the ankle dorsiflexed and everted. The therapist then applies a high-velocity thrust distraction technique to the talocrural joint. Only one thrust will be applied and no audible cavitation is required. This manual therapy technique will be performed once.
| Study group | Role | What they receive |
|---|---|---|
| Mobilization with Movement | Experimental | A weight- bearing mobilization directed to the talocrural joint in a standing position. Receives: Other: Mobilization with Movement |
| Thrust Mobilization | Experimental | A high velocity, low amplitude thrust mobilization directed to the talocrural joint with the participant in a non-weight bearing position. Receives: Other: Thrust Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline Multiple Hop Test immediately after intervention and at 1 week follow-up.
The participants will hop between 10 pieces of white 2 x 2 cm tape. Participants will be instructed to hop once between each numbered marker and avoid any postural corrections. Participants will be allowed to progress if they were able to stand still keeping their hands on their hips at each marker. Three trials on each leg will be performed and amount of time to complete trial, number of fixed-support, and change-in-support balance strategies will be recorded. The average of the three trials will be taken.
Measured: Baseline, immediately after intervention, and 1 week
Change in baseline weight bearing lunge test (WBLT) immediately after intervention and at 1 week follow-up.
Weight-bearing dorsiflexion range of motion (ROM) will be measured using the lunge test with a digital inclinometer (Acumar Single Digital Inclinometer Model ACU001) placed on a marked spot 15 cm below the base of the tibial tuberosity. Participants will place their hands on the wall and touch a vertical line with their knee, while keeping their knee in line with their second toe and their heel on the ground. Participants will perform three trials on either leg and the average of three test trials will be recorded.
Measured: Baseline, immediately after intervention, and 1 week
Change in baseline Star Excursion Balance Test (SEBT) immediately after intervention and at 1 week follow-up.
Each participant is asked to maintain single-limb stance, with hands on their hips, while reaching in anterior, posteromedial, and posterolateral directions.
Measured: Baseline, immediately after intervention, and 1 week
Change in baseline Foot and Ankle Ability Measure (FAAM)- Activities of Daily Living (ADL) Subscale immediately after intervention and at 1 week follow-up.
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, immediately after intervention, and 1 week
Change in baseline Foot and Ankle Ability Measure (FAAM)- Sport subscale immediately after intervention and at 1 week follow-up.
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, immediately after intervention, and 1 week
Change in baseline Cumberland Ankle Instability Tool (CAIT) immediately after intervention and at 1 week follow-up.
9-item questionnaire that helps discriminate and measure the severity of functional ankle instability.
Measured: Baseline, immediately after intervention, and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study startApr 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
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 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
- Responsible party
- Principal investigator, Cameron Bolton, Shenandoah University
- Investigators
- Cameron Bolton, PT, DPT, Principal investigator, Shenandoah University Division of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918473
- Sponsor's protocol ID
- 668
- Status last verified
- Apr 2019
- First submitted
- 2 Apr 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 24377963
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mobilization Versus Manipulation on Function in Participants Reporting Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT03918473
- Acronym / sponsor ID
- 668
- Conditions
- Ankle Sprains
- Keywords
- Functional Performance, Manual Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shenandoah UniversityUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 17 Apr 2019 (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.
The investigator's purpose is to compare the effects of talocrural joint mobilization with movement versus thrust mobilization 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 comparing the effects of mobilization with movement (MWM) versus thrust mobilization (TM) directed at the talocrural joint on functional performance 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 MWM or TM group.
The MWM group will receive manual therapy with the following protocol: the participant will be relaxed and standing in a staggered stance with the involved foot on an eight inch step and both feet facing forward . The clinician will be positioned in front of the participant's leg and a non-elastic belt will be placed around the distal leg of the participant and the clinician's pelvis. The clinician will then apply a sustained posteroanterior glide to the tibia through the belt by leaning backwards, while stabilizing the fixed talus and forefoot with both hands. The participant will perform a slow lunge until the end range of motion without their heel lifting off the ground. The belt will be kept perpendicular to the tibia throughout the movement and 2 sets of 10 repetitions will be applied.
The talocrural joint TM will be a high velocity low amplitude manual therapy technique. This technique will be applied with the participant in the supine position on a plinth. The clinician grasps the foot with one hand with the fifth finger contacting the anterior surface of the ankle at the talus. The other hand reinforces the contact points and both thumbs are placed on the sole of the participant's foot. The clinician gives slight caudal traction focused on the talocrural joint with the ankle dorsiflexed and everted. The therapist then applies a high-velocity thrust distraction technique to the talocrural joint. Only one thrust will be applied and no audible cavitation is required. Each manual therapy technique will be performed once.
An examiner, who is blinded to involved limb and group allocation, will perform a baseline, immediate follow-up, and one-week follow-up examination of range of motion and functional performance. The participants will complete subjective outcome measures at baseline, immediately post intervention, and at 1 week post intervention including the Foot and Ankle Ability Measurement (FAAM), FAAM-Sport, and the Cumberland Ankle Instability Tool (CAIT). Participants will also complete baseline, immediate follow-up, and one-week follow up assessments of the Multiple Hop Test (MHT), three directions of the Star Excursion Balance test (SEBT), and weight bearing lunge test (WBLT).
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, CAIT, MHT, WBLT, 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 with Movement | Experimental | Other: Mobilization with MovementA weight- bearing mobilization directed to the talocrural joint in a standing position. |
| Thrust Mobilization | Experimental | Other: Thrust MobilizationA high velocity, low amplitude thrust mobilization directed to the talocrural joint with the participant in a non-weight bearing position. |
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 (i.e., 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 (i.e., 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 |
|---|---|---|
| Mobilization with MovementThe MWM group will receive manual therapy with the following protocol: the participant will be relaxed and standing in a staggered stance with the involved foot on an eight-inch step and both feet facing forward. The clinician will be positioned in front of the participant's leg and a non-elastic belt will be placed around the distal leg of the participant and the clinician's pelvis. The clinician will then apply a sustained posteroanterior glide to the tibia through the belt by leaning backwards, while stabilizing the fixed talus and forefoot with both hands. The participant will perform a slow lunge until the end range of motion without their heel lifting off the ground. The belt will be kept perpendicular to the tibia throughout the movement and 2 sets of 10 repetitions will be applied. | Other | Mobilization with Movement |
| Thrust MobilizationThe talocrural joint TM will be a high velocity low amplitude manual therapy technique. This technique will be applied with the participant in the supine position on a plinth. The clinician grasps the foot with one hand with the fifth finger contacting the anterior surface of the ankle at the talus. The other hand reinforces the contact points and both thumbs are placed on the sole of the participant's foot. The clinician gives slight caudal traction focused on the talocrural joint with the ankle dorsiflexed and everted. The therapist then applies a high-velocity thrust distraction technique to the talocrural joint. Only one thrust will be applied and no audible cavitation is required. This manual therapy technique will be performed once. | Other | Thrust Mobilization |
Primary outcome
Change in baseline Multiple Hop Test immediately after intervention and at 1 week follow-up.
Time frame: Baseline, immediately after intervention, and 1 week
The participants will hop between 10 pieces of white 2 x 2 cm tape. Participants will be instructed to hop once between each numbered marker and avoid any postural corrections. Participants will be allowed to progress if they were able to stand still keeping their hands on their hips at each marker. Three trials on each leg will be performed and amount of time to complete trial, number of fixed-support, and change-in-support balance strategies will be recorded. The average of the three trials will be taken.
Change in baseline weight bearing lunge test (WBLT) immediately after intervention and at 1 week follow-up.
Time frame: Baseline, immediately after intervention, and 1 week
Weight-bearing dorsiflexion range of motion (ROM) will be measured using the lunge test with a digital inclinometer (Acumar Single Digital Inclinometer Model ACU001) placed on a marked spot 15 cm below the base of the tibial tuberosity. Participants will place their hands on the wall and touch a vertical line with their knee, while keeping their knee in line with their second toe and their heel on the ground. Participants will perform three trials on either leg and the average of three test trials will be recorded.
Change in baseline Star Excursion Balance Test (SEBT) immediately after intervention and at 1 week follow-up.
Time frame: Baseline, immediately after intervention, and 1 week
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 immediately after intervention and at 1 week follow-up.
Time frame: Baseline, immediately after intervention, and 1 week
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 immediately after intervention and at 1 week follow-up.
Time frame: Baseline, immediately after intervention, and 1 week
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 Cumberland Ankle Instability Tool (CAIT) immediately after intervention and at 1 week follow-up.
Time frame: Baseline, immediately after intervention, and 1 week
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 2019.
- 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.
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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 Bolton, PT, DPT 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 Mobilization with Movement and Thrust Mobilization in people with Ankle Sprains, 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 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 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cameron Bolton, PT, 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 Multiple Hop Test immediately after intervention and at 1 week follow-up. (time frame: Baseline, immediately after intervention, and 1 week). 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 NCT03918473, 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 17 Apr 2019.