Aging ProblemsANKLE_JOINTNCT03898999
Relationship of de Ankle ROM With Balance and Falls in Older Adults
An observational study of Aging Problems, run by University of Valencia at 1 site in Spain.
Trial summary
The ankle is an important joint to maintain a good balance within the population of the older adult. As people get older, problems appear in this joint. Many of these problems affect the correct joint range of the ankle. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aging Problems
- What is being tested?
- Overall status
- How many people
- 87 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2019to 1 Sep 2019
- Phase
- Observational
- 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
- Adult, Older adult
Study population: The subjects must belong to the population of older adults, who must not present serious pathologies that make their balance or mobility difficult, although they can use aids.
Who may be able to join
- Be 60 years old or older
Who cannot join
- Do not sign the informed consent
- Lower limb injury in the previous three months
- Presenting severe pathology that affects balance or mobility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship of the Ankle ROM With Balance and Falls in Older Adults: Observational Study
The ankle is an important joint to maintain a good balance within the population of the older adult. As people get older, problems appear in this joint. Many of these problems affect the correct joint range of the ankle. There is evidence to suggest that a lower range of motion in the ankle can negatively affect balance and, consequently, increase the risk of falls in the elderly. It would be interesting to assess if this relationship is true. The aim of the study will be to study if the state of the joint range of the ankle is related in some way to balance and falls in the elderly.
- Conditions
- Aging Problems
- Being tested
- Overall status
- Keywords
- Ankle, Balance, Falls, Older Adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overall statusOther
An assessment is made of the participants measuring both the joint range of the ankle and the balance and risk of falls.
| Study group | Role | What they receive |
|---|---|---|
| Older adult | Individuals belonging to the population group of the elderly (60 years or more) Receives: Other: Overall status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lunge Test (°)
Measure of weight-bearing ankle dorsiflexion with an inclinometer.
Measured: Baseline
Active Ankle Range of Movement
Measure of the active range of movement of the ankle with a telescopic goniometer.
Measured: Baseline
Secondary outcomes (8)
Pressure Platform - Open Eyes
Measure static balance. Quantitative assess of area and speed of swing, with open eyes.
Measured: Baseline
Pressure Platform - Closed Eyes
Measure static balance. Quantitative assess of area and speed of swing, with closed eyes.
Measured: Baseline
One Leg Balance
Measure balance ability to maintain in monopodal stance, towards registering time.
Measured: Baseline
Timed "Up and Go" Test
Measures the functional mobility and dynamic balance, through a circuit where the subject will have to get up, walk and sit down.
Measured: Baseline
Functional Reach
Measure the limits of stability, calculating the distance that can move the center of gravity forward without falling.
Measured: Baseline
Falls Efficacy Scale-International
Is a scale that, through 16 items, describes the concern that a subject has to suffer a fall.
Measured: Baseline
Register of falls
The number of falls that the subject has suffered in the last year is collected.
Measured: Baseline
Ankle plantar flexion strength
The plantar flexion strength is measured by means of a dynamometer, is related with the risk of falls.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Apr 2019
- Primary completion1 May 2019
- Study completion1 Sep 2019
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 87 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
- David Hernández-Guillén, PT, Principal investigator, University of ValenciaJose M Blasco, PhD, PT, Study director, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898999
- Sponsor's protocol ID
- DHG04
- Acronym
- ANKLE_JOINT
- Status last verified
- Dec 2019
- First submitted
- 30 Mar 2019
- Last updated
- 9 Dec 2019
- 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 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of the Ankle ROM With Balance and Falls in Older Adults: Observational Study
- ClinicalTrials.gov ID
- NCT03898999
- Acronym / sponsor ID
- ANKLE_JOINT / DHG04
- Conditions
- Aging Problems
- Keywords
- Ankle, Balance, Falls, Older Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 2 Apr 2019 (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.
The ankle is an important joint to maintain a good balance within the population of the older adult. As people get older, problems appear in this joint. Many of these problems affect the correct joint range of the ankle. There is evidence to suggest that a lower range of motion in the ankle can negatively affect balance and, consequently, increase the risk of falls in the elderly. It would be interesting to assess if this relationship is true. The aim of the study will be to study if the state of the joint range of the ankle is related in some way to balance and falls in the elderly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older adult | – | Other: Overall statusIndividuals belonging to the population group of the elderly (60 years or more) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The subjects must belong to the population of older adults, who must not present serious pathologies that make their balance or mobility difficult, although they can use aids.
Key inclusion criteria (1 listed)
- Be 60 years old or older
Key exclusion criteria (3 listed)
- Do not sign the informed consent
- Lower limb injury in the previous three months
- Presenting severe pathology that affects balance or mobility
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 |
|---|---|---|
| Overall statusAn assessment is made of the participants measuring both the joint range of the ankle and the balance and risk of falls. | Other | Older adult |
Primary outcome
Lunge Test (°)
Time frame: Baseline
Measure of weight-bearing ankle dorsiflexion with an inclinometer.
Active Ankle Range of Movement
Time frame: Baseline
Measure of the active range of movement of the ankle with a telescopic goniometer.
8 secondary outcomes
Pressure Platform - Open Eyes
Time frame: Baseline
Pressure Platform - Closed Eyes
Time frame: Baseline
One Leg Balance
Time frame: Baseline
Timed "Up and Go" Test
Time frame: Baseline
Functional Reach
Time frame: Baseline
Falls Efficacy Scale-International
Time frame: Baseline
Register of falls
Time frame: Baseline
Ankle plantar flexion strength
Time frame: Baseline
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 9 Dec 2019.
- 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.
David Hernández-Guillén, PT principal investigator
University of Valencia
Jose M Blasco, PhD, PT study director
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 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: finished, as of the sponsor's last update on 9 Dec 2019. 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 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?
Lunge 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 9 Dec 2019.