Aging ProblemsANKLE_ROMNCT04360512
Dose-response of Talus Mobilizations
A study testing Posteriorization of the talus in people with Aging Problems, run by University of Valencia at 1 site in Spain.
Trial summary
Ankle mobility limitations are common in older adults. A possible treatment to restore joint mobility is manual therapy based on mobilization techniques, in this case, applied on the ankle joint. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging Problems
- What is being tested?
- Posteriorization of the talus
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2020to 14 Sep 2020
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community-dwelling older adults
- Over 60 years
- Limited ankle dorsiflexion range of motion
Who cannot join
- Not willing to participate or signing a consent form
- Lower limb injury in the three months prior to the study (ex. sprain)
- Diagnosed condition that may influence mobility assessments (i.e. stroke)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose-response of Posterior Talus Mobilizations on Ankle Range of Motion and Overall Mobility in Older Adults
Ankle mobility limitations are common in older adults. A possible treatment to restore joint mobility is manual therapy based on mobilization techniques, in this case, applied on the ankle joint. Previous research had proposed different treatment volumes (one to twelve sessions), but shown a different and non-consistent degree of effectiveness according to such factor. Therefore, this work aims to determine the dose-response relationship of manual therapy (talus mobilizations) on ankle range of motion in the older adult. Secondarily, this research will appraise whether a likely improvement in ankle mobility may have an impact on the overall mobility (i.e. gait, get up from a chair).
- Conditions
- Aging Problems
- Being tested
- Posteriorization of the talus
- Keywords
- ROM, Manual therapy, Dose-response, Mobilization, Ankle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posteriorization of the talusProcedure or surgery
Three sets of a 30-s grade IV mobilization
| Study group | Role | What they receive |
|---|---|---|
| One session | Experimental | One session of talus posteriorization Receives: Procedure: Posteriorization of the talus |
| Two sessions | Experimental | Two sessions of talus posteriorization Receives: Procedure: Posteriorization of the talus |
| Three sessions | Experimental | Three sessions of talus posteriorization Receives: Procedure: Posteriorization of the talus |
| Four sessions | Experimental | Four sessions of talus posteriorization Receives: Procedure: Posteriorization of the talus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment dose
Number of sessions of experimental intervention needed to induce a clinically important gain in ankle mobility after the intervention. A baseline progression over 4.6º in the Lunge test will be considered clinically important (Powden, 2015), so that the number of sessions will be established when this threshold is exceeded (see secondary outcome) .
Measured: Change from baseline to end of intervention (2 weeks)
Secondary outcomes (3)
The Lunge test
Weight bearing ankle dorsiflexion range of motion. This test will measure the maximum tilt of the tibia that a subject can perform while standing and bearing the weight on the limb without lifting the heel from the floor. A Baseline® Digital Inclinometer (Fabrication Enterprises Inc) will be used to assessed this outcome. Values below 35º indicate limited mobility. A baseline progression over 4.6º will be considered clinically important (Powden, 2015). This mobility gain will be used to determine the dose-response relationship: number of sessions of talus mobilizations needed to induce a clinically important gain in ankle mobility after the intervention (see primary outcome measure)
Measured: Change from baseline, to end of intervention (2 weeks) and follow-up (10 weeks)
Active ankle range of motion
Non-weight bearing active ankle range of motion in the sagittal plane: dorsi to plantarflexion full range of motion. This will be assessed with a telescopic goniometer, with the participant laying in supine with a wedge under the knees to eliminate the tension of the gastrocnemius muscles. Values below 59º indicate limited ankle mobility. The minimal detectable change for this measure has not been well established in literature. A baseline progression over 5.2º will be considered clinically important (Searle, 2018; Konor, 2012)
Measured: Change from baseline, to end of intervention (2 weeks) and follow-up (10 weeks)
Timed up and go test (TUG)
A timed test used to assess overall mobility and dynamic balance, in which the time taken to get up from and arm-chair, walk three meters, turn around a cone and come back to sit again, is registered to estimate the functional mobility. We will consider times below 12 s as normal performances in the study populattion, and below 13,5 s as low risk of falling. A baseline change over 2.08 s will be considered clinically important (Donoghue, 2019)
Measured: Change from baseline, to end of intervention (2 weeks) and follow-up (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start15 May 2020
- Primary completion29 May 2020
- Study completion14 Sep 2020
Why it stopped: Suspended due to the covid-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging ProblemsStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Hernández, University of Valencia
- Investigators
- José-María Blasco, PT, PhD, Study director, University of ValenciaDavid Hernández-Guillén, PT, PhD, Study chair, University of ValenciaCatalina Tolsada-Velasco, PT, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360512
- Sponsor's protocol ID
- DHG05
- Acronym
- ANKLE_ROM
- Status last verified
- Sep 2020
- First submitted
- 18 Apr 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-response of Posterior Talus Mobilizations on Ankle Range of Motion and Overall Mobility in Older Adults
- ClinicalTrials.gov ID
- NCT04360512
- Acronym / sponsor ID
- ANKLE_ROM / DHG05
- Conditions
- Aging Problems
- Keywords
- ROM, Manual therapy, Dose-response, Mobilization, Ankle
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Suspended due to the covid-19 pandemic.
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 24 Apr 2020 (actual)
- 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.
Ankle mobility limitations are common in older adults. A possible treatment to restore joint mobility is manual therapy based on mobilization techniques, in this case, applied on the ankle joint. Previous research had proposed different treatment volumes (one to twelve sessions), but shown a different and non-consistent degree of effectiveness according to such factor. Therefore, this work aims to determine the dose-response relationship of manual therapy (talus mobilizations) on ankle range of motion in the older adult. Secondarily, this research will appraise whether a likely improvement in ankle mobility may have an impact on the overall mobility (i.e. gait, get up from a chair).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| One session | Experimental | Procedure: Posteriorization of the talusOne session of talus posteriorization |
| Two sessions | Experimental | Procedure: Posteriorization of the talusTwo sessions of talus posteriorization |
| Three sessions | Experimental | Procedure: Posteriorization of the talusThree sessions of talus posteriorization |
| Four sessions | Experimental | Procedure: Posteriorization of the talusFour sessions of talus posteriorization |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Community-dwelling older adults
- Over 60 years
- Limited ankle dorsiflexion range of motion
Key exclusion criteria (3 listed)
- Not willing to participate or signing a consent form
- Lower limb injury in the three months prior to the study (ex. sprain)
- Diagnosed condition that may influence mobility assessments (i.e. stroke)
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 |
|---|---|---|
| Posteriorization of the talusThree sets of a 30-s grade IV mobilization | Procedure or surgery | Four sessions, One session, Three sessions, Two sessions |
Primary outcome
Treatment dose
Time frame: Change from baseline to end of intervention (2 weeks)
Number of sessions of experimental intervention needed to induce a clinically important gain in ankle mobility after the intervention. A baseline progression over 4.6º in the Lunge test will be considered clinically important (Powden, 2015), so that the number of sessions will be established when this threshold is exceeded (see secondary outcome) .
3 secondary outcomes
The Lunge test
Time frame: Change from baseline, to end of intervention (2 weeks) and follow-up (10 weeks)
Active ankle range of motion
Time frame: Change from baseline, to end of intervention (2 weeks) and follow-up (10 weeks)
Timed up and go test (TUG)
Time frame: Change from baseline, to end of intervention (2 weeks) and follow-up (10 weeks)
Results and safety
The study was stopped early (reason given: Suspended due to the covid-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
José-María Blasco, PT, PhD study director
University of Valencia
David Hernández-Guillén, PT, PhD study chair
University of Valencia
Catalina Tolsada-Velasco, PT principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posteriorization of the talus in people with Aging Problems, run by University of Valencia at 1 site in Spain.
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 3 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 16 Sep 2020. 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 Spain. 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 was stopped early (reason given: Suspended due to the covid-19 pandemic.). 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?
Treatment dose (time frame: Change from baseline to end of intervention (2 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 16 Sep 2020.