Ankle SprainPhase 1/2ACENCT00847769
Ankle Sprains and Corticospinal Excitability
A Phase 1/2 study testing High velocity, low amplitude stretch, Slow, mobilization stretch and Passive Positioning in people with Ankle Sprain, run by University of Southern California at 1 site in United States.
Trial summary
The purpose of this study is to determine changes in the brain associated with improvement in ankle range of motion following ankle manual therapy procedures in individuals with post-acute ankle sprains Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- High velocity, low amplitude stretch, Slow, mobilization stretch and Passive Positioning
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Aug 2011
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years
- Onset of ankle sprain at least 2 weeks prior to enrollment
- Foot and Ankle Ability Measure Activity of Daily Living subscale score less than or equal to 80%
- Ankle dorsiflexion range of motion less than or equal to 5 degrees
Who cannot join
- Current status of assisted ambulation (eg, use of cane or crutches)
- Inability to bear weight through the affected extremity immediately after injury combined with tenderness to palpation of the medial and lateral malleolar zones, styloid process of the 5th metatarsal, and navicular
- Positive anterior drawer or talar tilt dimple test
- Volume of the affected limb greater than 10% of the unaffected limb
- Previous history of ligament or bony reconstructive surgery to the ankle and foot
- Concomitant injury to other lower extremity joints
- Medical conditions that serve as contraindications to mobilization/manipulation and transcranial magnetic stimulation, such as presence of pacemaker, metal in head, 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.
United States1 site
University of Southern California
Los Angeles, California, 90089
About this study
Official title: Effect of Manual Therapy Intervention on Corticospinal Excitability in Individuals With Post-acute Ankle Sprains
The purpose of this study is to determine changes in the brain associated with improvement in ankle range of motion following ankle manual therapy procedures in individuals with post-acute ankle sprains
Read the detailed description
Physical therapists use many ways to treat joints that do not move well. One way takes 1-2 seconds. Another way may take up to 1 minute. Both stretches seem to work, but we do not know how. Certain changes in the brain and spinal cord may cause joints to become more flexible after these kinds of stretches. Right now, we do not have very much information about how these might work in people who have injured their ankle. This study will find out if changes in the brain cause better flexibility in the ankle joint after different kinds of stretches. In this study, subjects with a certain kind of ankle sprains and limited ankle joint flexibility will be assigned to 1 out of 3 groups. Subjects will not get to choose their groups. The first group will have an ankle stretch that lasts 1-2 seconds. The second group will have a stretch that last 1 minute. The third group will have their foot held without any stretching. We will use a machine to stimulate the brain and spinal cord to find out how these stretches affect the brain and spinal cord. The machine sends a magnetic signal to the brain, and we will measure how much signal gets through to the leg muscles using electrodes on the skin. We also will use 3 flexibility tests to find out how well each stretch worked. One test is with the subject lying on their stomach, and the others are with the subject standing up. To start the study, subjects will get their brain stimulated. They will then get their brain stimulated again one hour later. After the second stimulation, subjects will have their flexibility tested and then get 1 of the 3 treatments. After the treatment, subjects will get a last brain stimulation test and flexibility tests. We think subjects that get a fast stretch will have better brain function and flexibility than subjects that get the slow stretch or no stretch. To test our idea, we will compare how each group did with the brain stimulation and flexibility tests. We will also look at the relationship between brain function and flexibility.
- Conditions
- Ankle Sprain
- Being tested
- High velocity, low amplitude stretch, Slow, mobilization stretch, Passive Positioning
- Keywords
- Ankle Sprain
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High velocity, low amplitude stretchOther
Also called Manipulation, GPM-V
This group (n=9) will receive talocrural traction manipulation. With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface. A thrust will be delivered parallel to the long axis of the subject's lower leg after the treating therapist induces passive ankle dorsiflexion to end range.
Slow, mobilization stretchOther
Also called Articulation, Mobilization, Traction
This group (n=9) will receive talocrural traction mobilization. With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface. Traction will be delivered to the talocrural joint at the treating investigator's second perception of tissue resistance in 3 bouts of 30-second holds, separated by 10 seconds of rest.
Passive PositioningOther
Also called Passive Range of Motion, Placebo
This group (n=9) will receive the manual therapy control intervention. This will consist of the same patient and clinician preparation for the mobilization/manipulation techniques. However, a single standardized treating investigator will simply maintain passive ankle positioning for the duration of 1 deep inhalation and exhalation by the subject rather than induce an iatrogenic force characteristic of the intervention received by the other 2 comparison groups.
| Study group | Role | What they receive |
|---|---|---|
| High velocity, low amplitude stretch | Experimental | With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface. A thrust will be delivered parallel to the long axis of the subject's lower leg after the treating therapist induces passive ankle dorsiflexion to end range. Receives: Other: High velocity, low amplitude stretch |
| Slow, mobilization stretch | Active comparator | With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface. Traction will be delivered to the talocrural joint at the treating therapist's second perception of tissue resistance in 3 bouts of 30-second holds, separated by 10 seconds of rest. Receives: Other: Slow, mobilization stretch |
| Passive positioning | Sham comparator | With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface, which is similar to the positioning used for the active comparator groups. The treating investigator will maintain passive positioning of the ankle for the duration of 1 deep inhalation and exhalation by the subject rather than induce an iatrogenic force. Receives: Other: Passive Positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corticospinal motor excitability (transcranial magnetic stimulation variables)
Measured: Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement
Secondary outcomes (3)
Single leg squat reach test
Measured: Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement
Ankle flexibility test (laying on stomach)
Measured: Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement
Ankle flexibility test (standing against wall)
Measured: Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startDec 2008
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ankle SprainStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Pacific, American Physical Therapy Association
- Responsible party
- Principal investigator, Beth Fisher, University of Southern California
- Investigators
- Beth E Fisher, PhD, PT, Principal investigator, University of Southern CaliforniaTodd E Davenport, DPT, OCS, Study director, University of the Pacific
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847769
- Sponsor's protocol ID
- HS-08-00192
- Acronym
- ACE
- Status last verified
- Mar 2017
- First submitted
- 22 Jan 2009
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Fisher BE, Piraino A, Lee YY, Smith JA, Johnson S, Davenport TE, Kulig K. The Effect of Velocity of Joint Mobilization on Corticospinal Excitability in Individuals With a History of Ankle Sprain. J Orthop Sports Phys Ther. 2016 Jul;46(7):562-70. doi: 10.2519/jospt.2016.6602. Epub 2016 Jun 6.
PubMed 27266885Fisher BE, Davenport TE, Kulig K, Wu AD. Identification of potential neuromotor mechanisms of manual therapy in patients with musculoskeletal disablement: rationale and description of a clinical trial. BMC Neurol. 2009 May 21;9:20. doi: 10.1186/1471-2377-9-20.
PubMed 19460169
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Manual Therapy Intervention on Corticospinal Excitability in Individuals With Post-acute Ankle Sprains
- ClinicalTrials.gov ID
- NCT00847769
- Acronym / sponsor ID
- ACE / HS-08-00192
- Conditions
- Ankle Sprain
- Keywords
- Ankle Sprain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- University of the Pacific, American Physical Therapy Association
- Study start
- Dec 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 19 Feb 2009 (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 changes in the brain associated with improvement in ankle range of motion following ankle manual therapy procedures in individuals with post-acute ankle sprains
Detailed description
Physical therapists use many ways to treat joints that do not move well. One way takes 1-2 seconds. Another way may take up to 1 minute. Both stretches seem to work, but we do not know how. Certain changes in the brain and spinal cord may cause joints to become more flexible after these kinds of stretches. Right now, we do not have very much information about how these might work in people who have injured their ankle. This study will find out if changes in the brain cause better flexibility in the ankle joint after different kinds of stretches. In this study, subjects with a certain kind of ankle sprains and limited ankle joint flexibility will be assigned to 1 out of 3 groups. Subjects will not get to choose their groups. The first group will have an ankle stretch that lasts 1-2 seconds. The second group will have a stretch that last 1 minute. The third group will have their foot held without any stretching. We will use a machine to stimulate the brain and spinal cord to find out how these stretches affect the brain and spinal cord. The machine sends a magnetic signal to the brain, and we will measure how much signal gets through to the leg muscles using electrodes on the skin. We also will use 3 flexibility tests to find out how well each stretch worked. One test is with the subject lying on their stomach, and the others are with the subject standing up. To start the study, subjects will get their brain stimulated. They will then get their brain stimulated again one hour later. After the second stimulation, subjects will have their flexibility tested and then get 1 of the 3 treatments. After the treatment, subjects will get a last brain stimulation test and flexibility tests. We think subjects that get a fast stretch will have better brain function and flexibility than subjects that get the slow stretch or no stretch. To test our idea, we will compare how each group did with the brain stimulation and flexibility tests. We will also look at the relationship between brain function and flexibility.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High velocity, low amplitude stretch | Experimental | Other: High velocity, low amplitude stretchWith the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface. A thrust will be delivered parallel to the long axis of the subject's lower leg after the treating therapist induces passive ankle dorsiflexion to end range. |
| Slow, mobilization stretch | Active comparator | Other: Slow, mobilization stretchWith the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface. Traction will be delivered to the talocrural joint at the treating therapist's second perception of tissue resistance in 3 bouts of 30-second holds, separated by 10 seconds of rest. |
| Passive positioning | Sham comparator | Other: Passive PositioningWith the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface, which is similar to the positioning used for the active comparator groups. The treating investigator will maintain passive positioning of the ankle for the duration of 1 deep inhalation and exhalation by the subject rather than induce an iatrogenic force. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-60 years
- Onset of ankle sprain at least 2 weeks prior to enrollment
- Foot and Ankle Ability Measure Activity of Daily Living subscale score less than or equal to 80%
- Ankle dorsiflexion range of motion less than or equal to 5 degrees
Key exclusion criteria (7 listed)
- Current status of assisted ambulation (eg, use of cane or crutches)
- Inability to bear weight through the affected extremity immediately after injury combined with tenderness to palpation of the medial and lateral malleolar zones, styloid process of the 5th metatarsal, and navicular
- Positive anterior drawer or talar tilt dimple test
- Volume of the affected limb greater than 10% of the unaffected limb
- Previous history of ligament or bony reconstructive surgery to the ankle and foot
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 stretchAlso: Manipulation, GPM-VThis group (n=9) will receive talocrural traction manipulation. With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface. A thrust will be delivered parallel to the long axis of the subject's lower leg after the treating therapist induces passive ankle dorsiflexion to end range. | Other | High velocity, low amplitude stretch |
| Slow, mobilization stretchAlso: Articulation, Mobilization, TractionThis group (n=9) will receive talocrural traction mobilization. With the subject in a seated position on a treatment table and the lower extremity of interest stabilized to the table with a belt, a single standardized treating investigator will grasp the foot of interested with the thenar eminences on the foot's plantar surface. Traction will be delivered to the talocrural joint at the treating investigator's second perception of tissue resistance in 3 bouts of 30-second holds, separated by 10 seconds of rest. | Other | Slow, mobilization stretch |
| Passive PositioningAlso: Passive Range of Motion, PlaceboThis group (n=9) will receive the manual therapy control intervention. This will consist of the same patient and clinician preparation for the mobilization/manipulation techniques. However, a single standardized treating investigator will simply maintain passive ankle positioning for the duration of 1 deep inhalation and exhalation by the subject rather than induce an iatrogenic force characteristic of the intervention received by the other 2 comparison groups. | Other | Passive positioning |
Primary outcome
Corticospinal motor excitability (transcranial magnetic stimulation variables)
Time frame: Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement
3 secondary outcomes
Single leg squat reach test
Time frame: Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement
Ankle flexibility test (laying on stomach)
Time frame: Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement
Ankle flexibility test (standing against wall)
Time frame: Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement
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 4 Apr 2017.
- Derived from this study: PubMed 27266885Fisher BE, Piraino A, Lee YY, Smith JA, Johnson S, Davenport TE, Kulig K. The Effect of Velocity of Joint Mobilization on Corticospinal Excitability in Individuals With a History of Ankle Sprain. J Orthop Sports Phys Ther. 2016 Jul;46(7):562-70. doi: 10.2519/jospt.2016.6602. Epub 2016 Jun 6.
- Derived from this study: PubMed 19460169Fisher BE, Davenport TE, Kulig K, Wu AD. Identification of potential neuromotor mechanisms of manual therapy in patients with musculoskeletal disablement: rationale and description of a clinical trial. BMC Neurol. 2009 May 21;9:20. doi: 10.1186/1471-2377-9-20.
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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.
Beth E Fisher, PhD, PT principal investigator
University of Southern California
Todd E Davenport, DPT, OCS study director
University of the Pacific
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing High velocity, low amplitude stretch, Slow, mobilization stretch and Passive Positioning in people with Ankle Sprain, run by University of Southern California 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 7 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 4 Apr 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Corticospinal motor excitability (transcranial magnetic stimulation variables) (time frame: Pre-intervention measurement, 1 additional repeated pre-intervention measurement, post-intervention measurement). 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 NCT00847769, which also lists 2 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 4 Apr 2017.