Other Instability, Ankle and FootNCT02025569
The Effect of Strain-counterstrain on Ankle Instability
A study testing Strain Counterstrain in people with Other Instability, Ankle and Foot, run by Long Island University at 1 site in United States.
Trial summary
This study seeks to determine the effectiveness of Strain Counterstrain in the treatment of chronic ankle instability. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Other Instability, Ankle and Foot
- What is being tested?
- Strain Counterstrain
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jul 2009
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- history of at least 1 ankle sprain, with pain and/or limping for more than 1 day, at least 3 months earlier
- 3 of more episodes of ankle giving way in the last 12 months
- chronic instability attributed to the original sprain injury
- age between 18-55
Who cannot join
- history of fracture or surgery in the affected ankle
- any other lower extremity musculoskeletal injury on the side of the involved ankle
- vestibular dysfunction or disorder
- history of balance dysfunction
- history of stroke or any other neurological pathology or disease
- history of ACL injury
- current participation in physical therapy or rehabilitation for the ankle injury
- evidence of CNS dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Strain Counterstrain in the Treatment of Patients With Chronic Ankle Instability: a Randomized Clinical Trial
This study seeks to determine the effectiveness of Strain Counterstrain in the treatment of chronic ankle instability.
Read the detailed description
This study aimed to determine the effect of Strain Counterstrain (SCS) on dynamic balance and subjective sense of instability in individuals with chronic ankle instability (CAI). Although many studies have been published on CAI, the cause for this common clinical dysfunction remains inconclusive. No studies have assessed the effectiveness of SCS on CAI. Baseline information on all participants includes a demographic questionnaire, the Star Excursion Balance Test (SEBT), and the Foot and Ankle Ability Measure (FAAM). Participants were randomized into the SCS intervention group or the sham SCS control group. All participants received an intervention (as assigned) once a week for four weeks in addition to performing a prescribed home exercise program. At week four all participants repeated the outcome measures and completed a Global Rating of Change (GROC) form. The primary aim was examined with a 2-way analysis of variance (ANOVA).
- Conditions
- Other Instability, Ankle and Foot
- Being tested
- Strain Counterstrain, Sham strain counterstrain
- Keywords
- chronic ankle instability, lateral ankle sprain, manual therapy, star excursion balance test, strain and counterstrain
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strain CounterstrainOther
Sham strain counterstrainOther
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Strain counterstrain intervention Receives: Other: Strain Counterstrain |
| Control Group | Sham comparator | Sham Strain Counterstrain intervention Receives: Other: Sham strain counterstrain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Star Excursion Balance Test
A measure assessing dynamic standing balance as the individual stands on one leg and reaches, with the other leg, in eight different directions. The distances reached with the non-stance leg are measured.
Measured: baseline
Star Excursion Balance Test
A measure assessing dynamic standing balance as the individual stands on one leg and reaches, with the other leg, in eight different directions. The distances reached with the non-stance leg are measured.
Measured: 4 weeks
Secondary outcomes (2)
Foot and Ankle Ability Measure
This measures assesses ankle function skills subjectively via a questionnaire
Measured: baseline
Foot and Ankle Ability Measure
This measures assesses ankle function skills subjectively via a questionnaire
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startJan 2008
- Primary completionJul 2009
- Study completionJul 2009
Why it stopped: Data collection was terminated due to unavailability of additional participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Instability, Ankle and FootStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Long Island University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristiana Kahl Collins, PT, PhD, Long Island University
- Investigators
- Cristiana K Collins, PhD, Principal investigator, Long Island University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025569
- Sponsor's protocol ID
- CKCollins-SCS
- Status last verified
- Dec 2013
- First submitted
- 24 Dec 2013
- Last updated
- 1 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Strain Counterstrain in the Treatment of Patients With Chronic Ankle Instability: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02025569
- Acronym / sponsor ID
- CKCollins-SCS
- Conditions
- Other Instability, Ankle and Foot
- Keywords
- chronic ankle instability, lateral ankle sprain, manual therapy, star excursion balance test, strain and counterstrain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data collection was terminated due to unavailability of additional participants.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Long Island UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 1 Jan 2014 (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.
This study seeks to determine the effectiveness of Strain Counterstrain in the treatment of chronic ankle instability.
Detailed description
This study aimed to determine the effect of Strain Counterstrain (SCS) on dynamic balance and subjective sense of instability in individuals with chronic ankle instability (CAI). Although many studies have been published on CAI, the cause for this common clinical dysfunction remains inconclusive. No studies have assessed the effectiveness of SCS on CAI. Baseline information on all participants includes a demographic questionnaire, the Star Excursion Balance Test (SEBT), and the Foot and Ankle Ability Measure (FAAM). Participants were randomized into the SCS intervention group or the sham SCS control group. All participants received an intervention (as assigned) once a week for four weeks in addition to performing a prescribed home exercise program. At week four all participants repeated the outcome measures and completed a Global Rating of Change (GROC) form. The primary aim was examined with a 2-way analysis of variance (ANOVA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Strain CounterstrainStrain counterstrain intervention |
| Control Group | Sham comparator | Other: Sham strain counterstrainSham Strain Counterstrain intervention |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- history of at least 1 ankle sprain, with pain and/or limping for more than 1 day, at least 3 months earlier
- 3 of more episodes of ankle giving way in the last 12 months
- chronic instability attributed to the original sprain injury
- age between 18-55
Key exclusion criteria (8 listed)
- history of fracture or surgery in the affected ankle
- any other lower extremity musculoskeletal injury on the side of the involved ankle
- vestibular dysfunction or disorder
- history of balance dysfunction
- history of stroke or any other neurological pathology or disease
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 |
|---|---|---|
| Strain Counterstrain | Other | Experimental group |
| Sham strain counterstrain | Other | Control Group |
Primary outcome
Star Excursion Balance Test
Time frame: baseline
A measure assessing dynamic standing balance as the individual stands on one leg and reaches, with the other leg, in eight different directions. The distances reached with the non-stance leg are measured.
Star Excursion Balance Test
Time frame: 4 weeks
A measure assessing dynamic standing balance as the individual stands on one leg and reaches, with the other leg, in eight different directions. The distances reached with the non-stance leg are measured.
2 secondary outcomes
Foot and Ankle Ability Measure
Time frame: baseline
Foot and Ankle Ability Measure
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Data collection was terminated due to unavailability of additional participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2014.
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.
Cristiana K Collins, PhD principal investigator
Long Island 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 Strain Counterstrain in people with Other Instability, Ankle and Foot, run by Long Island 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 8 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: stopped early, as of the sponsor's last update on 1 Jan 2014. 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.
Are results available for this study?
The study was stopped early (reason given: Data collection was terminated due to unavailability of additional participants.). Results are not available in the source record.
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?
Star Excursion Balance Test (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jan 2014.