Aging ProblemsANKLE_ROMNCT03743857
Effects of Improvement of the Ankle Joint Range on Balance in the Elderly.
A study testing Manual Therapy in people with Aging Problems, run by University of Valencia at 1 site in Spain.
Trial summary
The effects of aging on the ankle joint will contribute negatively to balance in the elderly. Manual therapy is a technique that is usually used to treat ankle arthrokinematics, although there is little literature on this population. 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?
- Manual Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2018to 10 Jan 2019
- 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
- 60 years or more
Who cannot join
- Do not sign the consent
- No acute pathology (3 months)
- Vestibular pathology
- CNS disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Improvement of the Ankle Joint Range on Balance in the Elderly: Randomized Controlled Trial
The effects of aging on the ankle joint will contribute negatively to balance in the elderly. Manual therapy is a technique that is usually used to treat ankle arthrokinematics, although there is little literature on this population. This study seeks to investigate the effects that a mobilization on the ankle will produce in order to improve its joint range and if the balance of the older adult improves after the intervention.
- Conditions
- Aging Problems
- Being tested
- Manual Therapy
- Keywords
- Ankle, Balance, Manual Therapy, Older Adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyProcedure or surgery
AP ankle mobilization
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy | Experimental | 6 sessions of ankle manual therapy Receives: Procedure: Manual Therapy |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test Up and Go
It is a test in which the functional mobility of the participant is measured.
Measured: Change from baseline to day 21
One Leg Balance Test
The time that the participant can be with monopodal support is measured
Measured: Change from baseline to day 21
Functional Reach Test
It measures the ability to move the center of gravity forward without losing balance.
Measured: Change from baseline to day 21
Analysis of Center of Pressure
Measurement of the displacement of the center of pressures using a Pressure Platform.
Measured: Change from baseline to day 21
Secondary outcomes (4)
Active ankle range of movement
Measurement of the total active joint range of the ankle in discharge with a goniometer.
Measured: Change from baseline to day 21
Weight Bearing Dorsiflexion Lunge Test
Measurement of dorsiflexion of the ankle under load with an inclinometer.
Measured: Change from baseline to day 21
Falls Efficacy Scale
Scale that measures the worry of suffering a fall.
Measured: Change from baseline to day 21
Assessment of ankle plantar flexion muscle strength
Measurement of the strength of the plantar flexion of the ankle with a dynamometer.
Measured: Change from baseline to day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start1 Dec 2018
- Primary completion30 Dec 2018
- Study completion10 Jan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 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, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743857
- Sponsor's protocol ID
- DHG03
- Acronym
- ANKLE_ROM
- Status last verified
- Jan 2019
- First submitted
- 11 Nov 2018
- Last updated
- 29 Jan 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 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Improvement of the Ankle Joint Range on Balance in the Elderly: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03743857
- Acronym / sponsor ID
- ANKLE_ROM / DHG03
- Conditions
- Aging Problems
- Keywords
- Ankle, Balance, Manual Therapy, Older Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 16 Nov 2018 (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 effects of aging on the ankle joint will contribute negatively to balance in the elderly. Manual therapy is a technique that is usually used to treat ankle arthrokinematics, although there is little literature on this population. This study seeks to investigate the effects that a mobilization on the ankle will produce in order to improve its joint range and if the balance of the older adult improves after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy | Experimental | Procedure: Manual Therapy6 sessions of ankle manual therapy |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 60 years or more
Key exclusion criteria (4 listed)
- Do not sign the consent
- No acute pathology (3 months)
- Vestibular pathology
- CNS 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 |
|---|---|---|
| Manual TherapyAP ankle mobilization | Procedure or surgery | Manual Therapy |
Primary outcome
Test Up and Go
Time frame: Change from baseline to day 21
It is a test in which the functional mobility of the participant is measured.
One Leg Balance Test
Time frame: Change from baseline to day 21
The time that the participant can be with monopodal support is measured
Functional Reach Test
Time frame: Change from baseline to day 21
It measures the ability to move the center of gravity forward without losing balance.
Analysis of Center of Pressure
Time frame: Change from baseline to day 21
Measurement of the displacement of the center of pressures using a Pressure Platform.
4 secondary outcomes
Active ankle range of movement
Time frame: Change from baseline to day 21
Weight Bearing Dorsiflexion Lunge Test
Time frame: Change from baseline to day 21
Falls Efficacy Scale
Time frame: Change from baseline to day 21
Assessment of ankle plantar flexion muscle strength
Time frame: Change from baseline to day 21
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 29 Jan 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
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy 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 1 inclusion and 4 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 29 Jan 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?
Test Up and Go (time frame: Change from baseline to day 21). The study lists 4 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 29 Jan 2019.