GaitNCT01787721
Effect of Manipulation of the Ankle Joint on Gait
A study testing Ankle manipulation in people with Gait, run by University of Bridgeport at 1 site in United States.
Trial summary
The purpose of this study is to determine if manipulation of the ankle improves some measurable characteristics of how a person walks. The investigators hypothesize that the ankle will be able to bend better after manipulation and thus improve walking speed and reduce differences between the two limbs. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait
- What is being tested?
- Ankle manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Dec 2014
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Students will be screened for eligibility by testing their ability to perform a squat.
Who cannot join
- a recent (within one month) ankle sprain
- evidence of ankle instability
- cardiac condition
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Bridgeport College of Chiropractic Human Performance Laboratory
Bridgeport, Connecticut, 06604
About this study
Official title: Effect of Manipulation of the Tibiotalar Joint on Gait
The purpose of this study is to determine if manipulation of the ankle improves some measurable characteristics of how a person walks. The investigators hypothesize that the ankle will be able to bend better after manipulation and thus improve walking speed and reduce differences between the two limbs.
- Conditions
- Gait
- Being tested
- Ankle manipulation, Sham manipulation
- Keywords
- Gait, Ankle joint, Manipulation, Chiropractic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle manipulationProcedure or surgery
Sham manipulationOther
| Study group | Role | What they receive |
|---|---|---|
| Ankle manipulation | Experimental | Treatment will consist of manipulation of the tibiotalar joint intended to produce anterior to posterior glide of the tibia on the talus Receives: Procedure: Ankle manipulation |
| Sham manipulation | Sham comparator | Sham manipulative procedure of the tibiotalar joint. Receives: Other: Sham manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-selected walking speed
Subjects will pick the speed they want to walk on the treadmill but will be blinded to their choice. The actual speed chosen will be recorded.
Measured: Day 1 and 6 weeks
Secondary outcomes (2)
Change in side-to-side difference in stance phase
Measurement of the change in the difference in single stance phase between the left foot and right foot.
Measured: Day 1 and 6 weeks
Change in difference in step length from side-to-side
Measurement of the change in the difference in step length between the left foot and right foot
Measured: Day 1 and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Unable to recruit more than 2 subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GaitStudies 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bridgeport
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen M Perle, DC, MS, Principal investigator, University of Bridgeport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787721
- Sponsor's protocol ID
- UB-SMP-001
- Status last verified
- Dec 2014
- First submitted
- 5 Nov 2012
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Manipulation of the Tibiotalar Joint on Gait
- ClinicalTrials.gov ID
- NCT01787721
- Acronym / sponsor ID
- UB-SMP-001
- Conditions
- Gait
- Keywords
- Gait, Ankle joint, Manipulation, Chiropractic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit more than 2 subjects
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of BridgeportUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Feb 2013 (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 if manipulation of the ankle improves some measurable characteristics of how a person walks. The investigators hypothesize that the ankle will be able to bend better after manipulation and thus improve walking speed and reduce differences between the two limbs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ankle manipulation | Experimental | Procedure: Ankle manipulationTreatment will consist of manipulation of the tibiotalar joint intended to produce anterior to posterior glide of the tibia on the talus |
| Sham manipulation | Sham comparator | Other: Sham manipulationSham manipulative procedure of the tibiotalar joint. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Students will be screened for eligibility by testing their ability to perform a squat.
Key exclusion criteria (3 listed)
- a recent (within one month) ankle sprain
- evidence of ankle instability
- cardiac condition
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 manipulation | Procedure or surgery | Ankle manipulation |
| Sham manipulation | Other | Sham manipulation |
Primary outcome
Change in self-selected walking speed
Time frame: Day 1 and 6 weeks
Subjects will pick the speed they want to walk on the treadmill but will be blinded to their choice. The actual speed chosen will be recorded.
2 secondary outcomes
Change in side-to-side difference in stance phase
Time frame: Day 1 and 6 weeks
Change in difference in step length from side-to-side
Time frame: Day 1 and 6 weeks
Results and safety
The study was stopped early (reason given: Unable to recruit more than 2 subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
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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.
Stephen M Perle, DC, MS principal investigator
University of Bridgeport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle manipulation in people with Gait, run by University of Bridgeport 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 1 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: stopped early, as of the sponsor's last update on 23 Dec 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: Unable to recruit more than 2 subjects). 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?
Change in self-selected walking speed (time frame: Day 1 and 6 weeks). 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 23 Dec 2014.