Ankle SprainNCT01438905
Effect of Joint Mobilization in the Treatment of Chronic Ankle Instability
A study testing Small amplitude (Grade IV) mobilization and High velocity, low amplitude (Grade V) mobilization in people with Ankle Sprain, run by Creighton University at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of a gentle pressure movement performed at the ankle by a physical therapist on muscle function and ankle motion in individuals who frequently twist (sprain) their ankle. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- Small amplitude (Grade IV) mobilization and High velocity, low amplitude (Grade V) mobilization
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2012
- 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 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 16-45 years
- History of one or more ankle sprains
- Scoring at least an 85% on the Foot and Ankle Ability Measure (FAAM) Sport or at least 3 on the Modified Ankle Instability Instrument (AII).
- At least 5° ankle dorsiflexion asymmetry compared to the contralateral limb OR ankle dorsiflexion ROM less than 21°
Who cannot join
- Lower extremity injury or surgery within the past 6 months (including lateral ankle sprain)
- Diagnosed ankle osteoarthritis
- History of ankle surgery that involves intra-articular fixation
- Medical conditions which would be contraindications to mobilization/manipulation and/or transcranial magnetic stimulation, including cardiac pacemaker, metal implants in the head, current pregnancy, neurological disorders, recent use of stimulants or medications known to lower seizure threshold, and personal or family history of seizures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Joint Mobilization on Muscle Activation and Function in Individuals With Chronic Ankle Instability
The purpose of this study is to examine the effects of a gentle pressure movement performed at the ankle by a physical therapist on muscle function and ankle motion in individuals who frequently twist (sprain) their ankle.
Read the detailed description
Novel rehabilitation methods, that specifically target decreased muscle activation due to joint pathology prior to strength training, have elicited greater improvements in muscle function and self-reported disability compared to traditional therapies. Preliminary evidence suggests ankle joint mobilization can improve contributions of spinal influences on ankle muscle activation in individuals with ankle joint pathology, but there is a considerable gap in understanding cortical contributions to muscle activation following joint injury. It is unknown how joint mobilization concurrently affects cortical and spinal neural motor pathways, as well as clinical measures of patient function. The overall aim of this grant is to determine the immediate effects of talocrural joint mobilization on cortical and spinal muscle activation of the fibularis longus (peroneus) and soleus muscles in individuals with chronic ankle instability (CAI). The secondary aims of this study will examine changes in ankle dorsiflexion range of motion (ROM) and dynamic balance. This innovate approach will provide the necessary scientific knowledge regarding the potential mechanism and efficacy of joint mobilization.
- Conditions
- Ankle Sprain
- Being tested
- Small amplitude (Grade IV) mobilization, High velocity, low amplitude (Grade V) mobilization
- Keywords
- Ankle Sprain, Chronic Ankle Instability, Ankle Mobilization, Talocrural Joint Mobilization, Cortical Muscle Activation, Spinal Muscle Activation
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small amplitude (Grade IV) mobilizationOther
The subject will be in a seated position and the therapist will stabilize the distal tibia with one hand and make contact the anterior talus with the opposite hand. Three 60-second anterior to posterior joint mobilizations of the talus (small amplitude at end range; Grade IV) will be applied by the therapist with one minute rest in between sets.
High velocity, low amplitude (Grade V) mobilizationOther
Also called Manipulation, Grade V mobilization, High velocity, low amplitude thrust
The subject will be in a seated position and the therapist will grasp the dorsum of the foot with their fingers. The ankle will be dorsiflexed until the restrictive barrier is reached. A small amplitude, quick thrust at end of range (High velocity, low amplitude; Grade V mobilization/manipulation) will be applied. If joint cavitation is not felt or heard by the therapist or subject the technique will be repeated one additional time.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Parameters will be identical to the lower intensity (Small amplitude oscillation mobilization; Grade IV) talocrural mobilization. No force, other than light hand contact will be applied by the therapist. |
| Lower intensity mobilization | Experimental | The subject will be in a seated position and the therapist will stabilize the distal tibia with one hand and make contact the anterior talus with the opposite hand. Three 60-second anterior to posterior joint mobilizations of the talus (small amplitude at end range; Grade IV) will be applied by the therapist with one minute rest in between sets. Receives: Other: Small amplitude (Grade IV) mobilization |
| Higher intensity mobilization | Experimental | The subject will be in a seated position and the therapist will grasp the dorsum of the foot with their fingers. The ankle will be dorsiflexed until the restrictive barrier is reached. A small amplitude, quick thrust at end of range (High velocity, low amplitude; Grade V mobilization/manipulation) will be applied. If joint cavitation is not felt or heard by the therapist or subject the technique will be repeated one additional time. Receives: Other: High velocity, low amplitude (Grade V) mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Muscle activation
To determine cortical and spinal changes in muscle activation of the fibularis longus and soleus following one of three intervention protocols. Changes in cortical and spinal muscle activation will be measured by examining resting motor threshold via Transcranial Magnetic Stimulation and the H-reflex technique, respectively.
The investigators hypothesize that the higher intensity talocrural joint mobilization will result in a greater increase in cortical and spinal activation of the fibularis longus and soleus muscles than the lower intensity talocrural joint mobilization.
Measured: Baseline and immediately after each manual therapy intervention; 1 week study
Changes in Ankle dorsiflexion ROM
To determine the changes in ankle dorsiflexion ROM following one of two talocrural joint mobilization techniques (higher or lower intensity) or control intervention in individuals with CAI. Changes in ankle dorsiflexion ROM will be quantified using a weight bearing lunge.
The investigators hypothesize that the higher intensity (Grade V) talocrural joint mobilization will result in a greater improvement in ankle dorsiflexion ROM than the lower intensity (Grade IV) talocrural joint mobilization and the control intervention will result in no change in ROM.
Measured: Baseline and immediately after each manual therapy intervention; 1 week study
Changes in Dynamic Balance
To determine the acute changes in balance following one of two talocrural joint mobilization techniques or control intervention in individuals with CAI. Changes in balance will be quantified using the anterior, posteromedial, and posterolateral components of the Star Excursion Balance Test.
The investigators hypothesize that the higher intensity talocrural joint mobilization will result in greater improvements in reach distance in all three SEBT directions compared to the lower intensity talocrural joint mobilization.
Measured: Baseline and immediately after each manual therapy intervention; 1 week study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2012
- Study completionDec 2012
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 SprainStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- Nebraska Foundation for Physical Therapy
- Responsible party
- Sponsor
- Investigators
- Terry L Grindstaff, PhD, PT, ATC, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438905
- Sponsor's protocol ID
- 11-16058
- Status last verified
- Feb 2018
- First submitted
- 14 Sep 2011
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Grindstaff TL, Dolan N, Morton SK. Ankle dorsiflexion range of motion influences Lateral Step Down Test scores in individuals with chronic ankle instability. Phys Ther Sport. 2017 Jan;23:75-81. doi: 10.1016/j.ptsp.2016.07.008. Epub 2016 Jul 29.
PubMed 27662790
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Joint Mobilization on Muscle Activation and Function in Individuals With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT01438905
- Acronym / sponsor ID
- 11-16058
- Conditions
- Ankle Sprain
- Keywords
- Ankle Sprain, Chronic Ankle Instability, Ankle Mobilization, Talocrural Joint Mobilization, Cortical Muscle Activation, Spinal Muscle Activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- Nebraska Foundation for Physical Therapy
- Study start
- Sep 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 22 Sep 2011 (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 examine the effects of a gentle pressure movement performed at the ankle by a physical therapist on muscle function and ankle motion in individuals who frequently twist (sprain) their ankle.
Detailed description
Novel rehabilitation methods, that specifically target decreased muscle activation due to joint pathology prior to strength training, have elicited greater improvements in muscle function and self-reported disability compared to traditional therapies. Preliminary evidence suggests ankle joint mobilization can improve contributions of spinal influences on ankle muscle activation in individuals with ankle joint pathology, but there is a considerable gap in understanding cortical contributions to muscle activation following joint injury. It is unknown how joint mobilization concurrently affects cortical and spinal neural motor pathways, as well as clinical measures of patient function. The overall aim of this grant is to determine the immediate effects of talocrural joint mobilization on cortical and spinal muscle activation of the fibularis longus (peroneus) and soleus muscles in individuals with chronic ankle instability (CAI). The secondary aims of this study will examine changes in ankle dorsiflexion range of motion (ROM) and dynamic balance. This innovate approach will provide the necessary scientific knowledge regarding the potential mechanism and efficacy of joint mobilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Parameters will be identical to the lower intensity (Small amplitude oscillation mobilization; Grade IV) talocrural mobilization. No force, other than light hand contact will be applied by the therapist. |
| Lower intensity mobilization | Experimental | Other: Small amplitude (Grade IV) mobilizationThe subject will be in a seated position and the therapist will stabilize the distal tibia with one hand and make contact the anterior talus with the opposite hand. Three 60-second anterior to posterior joint mobilizations of the talus (small amplitude at end range; Grade IV) will be applied by the therapist with one minute rest in between sets. |
| Higher intensity mobilization | Experimental | Other: High velocity, low amplitude (Grade V) mobilizationThe subject will be in a seated position and the therapist will grasp the dorsum of the foot with their fingers. The ankle will be dorsiflexed until the restrictive barrier is reached. A small amplitude, quick thrust at end of range (High velocity, low amplitude; Grade V mobilization/manipulation) will be applied. If joint cavitation is not felt or heard by the therapist or subject the technique will be repeated one additional time. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 16-45 years
- History of one or more ankle sprains
- Scoring at least an 85% on the Foot and Ankle Ability Measure (FAAM) Sport or at least 3 on the Modified Ankle Instability Instrument (AII).
- At least 5° ankle dorsiflexion asymmetry compared to the contralateral limb OR ankle dorsiflexion ROM less than 21°
Key exclusion criteria (4 listed)
- Lower extremity injury or surgery within the past 6 months (including lateral ankle sprain)
- Diagnosed ankle osteoarthritis
- History of ankle surgery that involves intra-articular fixation
- Medical conditions which would be contraindications to mobilization/manipulation and/or transcranial magnetic stimulation, including cardiac pacemaker, metal implants in the head, current pregnancy, neurological disorders, recent use of stimulants or medications known to lower seizure threshold, and personal or family history of seizures
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 |
|---|---|---|
| Small amplitude (Grade IV) mobilizationThe subject will be in a seated position and the therapist will stabilize the distal tibia with one hand and make contact the anterior talus with the opposite hand. Three 60-second anterior to posterior joint mobilizations of the talus (small amplitude at end range; Grade IV) will be applied by the therapist with one minute rest in between sets. | Other | Lower intensity mobilization |
| High velocity, low amplitude (Grade V) mobilizationAlso: Manipulation, Grade V mobilization, High velocity, low amplitude thrustThe subject will be in a seated position and the therapist will grasp the dorsum of the foot with their fingers. The ankle will be dorsiflexed until the restrictive barrier is reached. A small amplitude, quick thrust at end of range (High velocity, low amplitude; Grade V mobilization/manipulation) will be applied. If joint cavitation is not felt or heard by the therapist or subject the technique will be repeated one additional time. | Other | Higher intensity mobilization |
Primary outcome
Changes in Muscle activation
Time frame: Baseline and immediately after each manual therapy intervention; 1 week study
To determine cortical and spinal changes in muscle activation of the fibularis longus and soleus following one of three intervention protocols. Changes in cortical and spinal muscle activation will be measured by examining resting motor threshold via Transcranial Magnetic Stimulation and the H-reflex technique, respectively. The investigators hypothesize that the higher intensity talocrural joint mobilization will result in a greater increase in cortical and spinal activation of the fibularis longus and soleus muscles than the lower intensity talocrural joint mobilization.
Changes in Ankle dorsiflexion ROM
Time frame: Baseline and immediately after each manual therapy intervention; 1 week study
To determine the changes in ankle dorsiflexion ROM following one of two talocrural joint mobilization techniques (higher or lower intensity) or control intervention in individuals with CAI. Changes in ankle dorsiflexion ROM will be quantified using a weight bearing lunge. The investigators hypothesize that the higher intensity (Grade V) talocrural joint mobilization will result in a greater improvement in ankle dorsiflexion ROM than the lower intensity (Grade IV) talocrural joint mobilization and the control intervention will result in no change in ROM.
Changes in Dynamic Balance
Time frame: Baseline and immediately after each manual therapy intervention; 1 week study
To determine the acute changes in balance following one of two talocrural joint mobilization techniques or control intervention in individuals with CAI. Changes in balance will be quantified using the anterior, posteromedial, and posterolateral components of the Star Excursion Balance Test. The investigators hypothesize that the higher intensity talocrural joint mobilization will result in greater improvements in reach distance in all three SEBT directions compared to the lower intensity talocrural joint mobilization.
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 23 Feb 2018.
- Derived from this study: PubMed 27662790Grindstaff TL, Dolan N, Morton SK. Ankle dorsiflexion range of motion influences Lateral Step Down Test scores in individuals with chronic ankle instability. Phys Ther Sport. 2017 Jan;23:75-81. doi: 10.1016/j.ptsp.2016.07.008. Epub 2016 Jul 29.
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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.
Terry L Grindstaff, PhD, PT, ATC principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small amplitude (Grade IV) mobilization and High velocity, low amplitude (Grade V) mobilization in people with Ankle Sprain, run by Creighton 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 4 inclusion and 4 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 23 Feb 2018. 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?
Changes in Muscle activation (time frame: Baseline and immediately after each manual therapy intervention; 1 week study). 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 NCT01438905, 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 23 Feb 2018.