Plantar FasciitisNCT00527748
Foot and Ankle Range of Motion (Stretching) Apparatus
A study testing Non-Measuring Ankle Exerciser in people with Plantar Fasciitis and Flatfoot, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Range of motion at ankle joint and subtalar joint will be assessed before and after utilization of ARM device. The changes in range of motion will be recorded and compared to literature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciitis, Flatfoot, Calcaneus Fractures
- What is being tested?
- Non-Measuring Ankle Exerciser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jul 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- stiffness in or about the ankle joint due to age, diabetes, trauma, flatfoot, plantar fasciitis, or immobilization
Who cannot join
- not physically able to use device
- patients with pain disorders
- patients lacking necessary hand-eye coordination
- patients using lower extremity external fixator
- patients with history of non-compliance
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri-Columbia Healthcare
Columbia, Missouri, 65212
About this study
Official title: The Use of a New Foot and Ankle Range of Motion (Stretching) Apparatus in Subjects With Stiff Ankles
Range of motion at ankle joint and subtalar joint will be assessed before and after utilization of ARM device. The changes in range of motion will be recorded and compared to literature.
Read the detailed description
The purpose of this study is to assess how effective a new device is in increasing range of motion and reducing stiffness in the foot and ankle of patients with acquired flatfoot, patients with plantar fasciitis, and those suffering from stiffness after cast removal or other lengthy immobilization.
Project will utilize a physical therapist to measure range of motion and stiffness when patients are consented. Patients will be re-measured at six weeks following use of the device to assist in stretching ankle and foot muscles, and again at 10 weeks for final stiffness and range of motion assessment.
- Conditions
- Plantar Fasciitis, Flatfoot, Calcaneus Fractures
- Being tested
- Non-Measuring Ankle Exerciser
- Keywords
- Range of Motion, Ankle Fractures, Elderly patients
- Medical subject headings
- Fasciitis, Plantar, Flatfoot, Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Measuring Ankle ExerciserDevice
Also called Ankle Recovery Mechanism (ARM)
Stretching exercise performed 10 times per day, for six (6) weeks.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Patient ankle range of motion will be assessed at clinic visit. No stretching exercises with the device, but will be provided standard care through physiotherapist in acute cases, and no stretching exercises for chronic patients. Reassessment will be done at six weeks and 10 weeks. |
| Non-Measuring Ankle Exerciser | Experimental | Subjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks. Reassessment will be done at six weeks and 10 weeks. Receives: Device: Non-Measuring Ankle Exerciser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Range of Motion
Participants randomized into ARM stretching device group will experience less ankle stiffness and an increased range of motion after using the stretching device, as compared to the control group receiving traditional physiotherapy.
Measured: Ten weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2011
- Study completionJul 2012
Why it stopped: Investigator left institution. No data analysis completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saul G Trevino, MD, Principal investigator, University of Missouri-Columbia School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527748
- Sponsor's protocol ID
- 1092357
- Status last verified
- Mar 2017
- First submitted
- 7 Sep 2007
- Last updated
- 21 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a New Foot and Ankle Range of Motion (Stretching) Apparatus in Subjects With Stiff Ankles
- ClinicalTrials.gov ID
- NCT00527748
- Acronym / sponsor ID
- 1092357
- Conditions
- Plantar Fasciitis, Flatfoot, Calcaneus Fractures
- Keywords
- Range of Motion, Ankle Fractures, Elderly patients
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator left institution. No data analysis completed.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 11 Sep 2007 (estimated)
- Results
- Posted 21 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Range of motion at ankle joint and subtalar joint will be assessed before and after utilization of ARM device. The changes in range of motion will be recorded and compared to literature.
Detailed description
The purpose of this study is to assess how effective a new device is in increasing range of motion and reducing stiffness in the foot and ankle of patients with acquired flatfoot, patients with plantar fasciitis, and those suffering from stiffness after cast removal or other lengthy immobilization.
Project will utilize a physical therapist to measure range of motion and stiffness when patients are consented. Patients will be re-measured at six weeks following use of the device to assist in stretching ankle and foot muscles, and again at 10 weeks for final stiffness and range of motion assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Patient ankle range of motion will be assessed at clinic visit. No stretching exercises with the device, but will be provided standard care through physiotherapist in acute cases, and no stretching exercises for chronic patients. Reassessment will be done at six weeks and 10 weeks. |
| Non-Measuring Ankle Exerciser | Experimental | Device: Non-Measuring Ankle ExerciserSubjects will train using only one combination of movement, dorsiflexion with inversion. This is done by manipulating the ring so that the medial and anterior ropes are taut. Subject will start with 3 minute warm-up. Subject will then manipulate the ring so that the foot moves into dorsiflexion with inversion until a point of tolerable discomfort is felt; subject will hold this position for 30 seconds. Stretch will be repeated 10 times, each day, for six weeks. Reassessment will be done at six weeks and 10 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- stiffness in or about the ankle joint due to age, diabetes, trauma, flatfoot, plantar fasciitis, or immobilization
Key exclusion criteria (5 listed)
- not physically able to use device
- patients with pain disorders
- patients lacking necessary hand-eye coordination
- patients using lower extremity external fixator
- patients with history of non-compliance
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 |
|---|---|---|
| Non-Measuring Ankle ExerciserAlso: Ankle Recovery Mechanism (ARM)Stretching exercise performed 10 times per day, for six (6) weeks. | Device | Non-Measuring Ankle Exerciser |
Primary outcome
Change in Range of Motion
Time frame: Ten weeks
Participants randomized into ARM stretching device group will experience less ankle stiffness and an increased range of motion after using the stretching device, as compared to the control group receiving traditional physiotherapy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Saul G Trevino, MD principal investigator
University of Missouri-Columbia School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Measuring Ankle Exerciser in people with Plantar Fasciitis and Flatfoot, run by University of Missouri-Columbia 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 2 inclusion and 5 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 21 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. 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?
Yes. Results are posted in the registry (first posted 21 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Range of Motion (time frame: Ten 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 21 Apr 2017.