Aging ProblemsFEET_BALANCENCT03092869
Effects of Feet and Ankle Mobilization on Balance of Older Adults
A study testing Feet and Ankle Mobilization and Proprioceptive Training in people with Aging Problems, run by University of Valencia at 2 sites in Spain.
Trial summary
This study aims to assess whether mobilization of the ankle and foot produces significant improvements in the balance of the elderly. To this end, a randomized study was designed with a control group that performs proprioception exercises and an experimental group that also performs a mobilization of the ankle and… 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?
- Feet and Ankle Mobilization and Proprioceptive Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesSpain
- Study dates
- 3 Apr 2017to 2 Sep 2017
- 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
- Old adults over 60 years
Who cannot join
- Subjects with balance disorders whether vestibular or central.
- Subjects with lower limb prosthesis.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Universidad de Valencia
Valencia, 46010
University of Valencia
Valencia, 46010
About this study
This study aims to assess whether mobilization of the ankle and foot produces significant improvements in the balance of the elderly.
To this end, a randomized study was designed with a control group that performs proprioception exercises and an experimental group that also performs a mobilization of the ankle and foot joints.
Read the detailed description
Aging leads to a decrease in physical activity and a reduction of postural control, which implies a loss of balance control, both static and dynamic, thus compromising the autonomy of the elderly and increasing the risk of suffering a fall. It has been observed that the balance degenerates in an accelerated way from 60 years of age. Basically appears a natural physiological degeneration of the organism, which affects strength, range of mobility, reduces vestibular function, there is loss vision and lower cardiopulmonary capacity.
In the older adult who suffers falls, in relation to the one who does not suffer, a series of differences or determinants have been observed. In this group, a series of characteristics such as the lower flexibility of the ankle joint and the muscle-tendon complex are present, hallux valgus appears, lower foot tenderness or a decrease in the strength in the first plantar flexor finger. They appear to have poorer balance and have less force in the flexors of the soles accompanied by less mobility of the foot inversion-eversion.
One of the causes that seems to contribute in the decrease of the balance in the older adult are the alterations in the ankle and foot, besides supposing a worse capacity of adaptation to the possible environmental changes. Before a deficit of this type, the subject tends to compensate for his position with compensatory strategies in other joints of the lower limb. It has also been shown that as we grow older, there is an increase in the demand for articulation of the other joints, such as the hip and knee, secondary to a decrease in joint range of ankle and foot or weakness of the dorsal flexors of the foot.
It follows that there is a relationship between alterations in the ankle and foot and the balance in the elderly, all related to the forces that suffer the ankle in the gait and to the low normal activity. Any alteration in this joint could predetermine an alteration of its function in maintaining stability in the elderly.
- Conditions
- Aging Problems
- Being tested
- Feet and Ankle Mobilization, Proprioceptive Training
- Keywords
- Feet, 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.
Feet and Ankle MobilizationOther
A set of manual therapy mobilization in feet and ankle joints
Proprioceptive TrainingOther
A set of proprioceptive exercises oriented to improve balance abilities
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Feet and Ankle Mobilization Receives: Other: Feet and Ankle Mobilization; Other: Proprioceptive Training |
| Control Group | Active comparator | Proprioceptive Training Receives: Other: Proprioceptive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
This is a 14 item scale used to assess the overall state of balance of the oder adult
Measured: Change from baseline to end of intervention (one month)
Secondary outcomes (3)
Test Up and Go
It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Measured: Change from baseline to end of intervention (one month)
Pressure Platform Outcome
Romberg test. Static balance when standing in the platform in a static position without moving the feet during 30 seconds
Measured: Change from baseline to end of intervention (one month)
Range of Movement
Flexion-extension range of movement of the ankle joint
Measured: Change from baseline to end of intervention (one month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start3 Apr 2017
- Primary completion1 Jul 2017
- Study completion2 Sep 2017
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
- 29 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, PT, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092869
- Sponsor's protocol ID
- DHG01
- Acronym
- FEET_BALANCE
- Status last verified
- Jun 2018
- First submitted
- 22 Mar 2017
- Last updated
- 8 Jun 2018
- 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 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Feet and Ankle Mobilization on Balance of Older Adults
- ClinicalTrials.gov ID
- NCT03092869
- Acronym / sponsor ID
- FEET_BALANCE / DHG01
- Conditions
- Aging Problems
- Keywords
- Feet, Ankle, Balance, Manual Therapy, Older Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 2 Sep 2017 (actual)
- First posted
- 28 Mar 2017 (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.
This study aims to assess whether mobilization of the ankle and foot produces significant improvements in the balance of the elderly.
To this end, a randomized study was designed with a control group that performs proprioception exercises and an experimental group that also performs a mobilization of the ankle and foot joints.
Detailed description
Aging leads to a decrease in physical activity and a reduction of postural control, which implies a loss of balance control, both static and dynamic, thus compromising the autonomy of the elderly and increasing the risk of suffering a fall. It has been observed that the balance degenerates in an accelerated way from 60 years of age. Basically appears a natural physiological degeneration of the organism, which affects strength, range of mobility, reduces vestibular function, there is loss vision and lower cardiopulmonary capacity.
In the older adult who suffers falls, in relation to the one who does not suffer, a series of differences or determinants have been observed. In this group, a series of characteristics such as the lower flexibility of the ankle joint and the muscle-tendon complex are present, hallux valgus appears, lower foot tenderness or a decrease in the strength in the first plantar flexor finger. They appear to have poorer balance and have less force in the flexors of the soles accompanied by less mobility of the foot inversion-eversion.
One of the causes that seems to contribute in the decrease of the balance in the older adult are the alterations in the ankle and foot, besides supposing a worse capacity of adaptation to the possible environmental changes. Before a deficit of this type, the subject tends to compensate for his position with compensatory strategies in other joints of the lower limb. It has also been shown that as we grow older, there is an increase in the demand for articulation of the other joints, such as the hip and knee, secondary to a decrease in joint range of ankle and foot or weakness of the dorsal flexors of the foot.
It follows that there is a relationship between alterations in the ankle and foot and the balance in the elderly, all related to the forces that suffer the ankle in the gait and to the low normal activity. Any alteration in this joint could predetermine an alteration of its function in maintaining stability in the elderly.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Feet and Ankle Mobilization, Other: Proprioceptive TrainingFeet and Ankle Mobilization |
| Control Group | Active comparator | Other: Proprioceptive TrainingProprioceptive Training |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Old adults over 60 years
Key exclusion criteria (2 listed)
- Subjects with balance disorders whether vestibular or central.
- Subjects with lower limb prosthesis.
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 |
|---|---|---|
| Feet and Ankle MobilizationA set of manual therapy mobilization in feet and ankle joints | Other | Experimental Group |
| Proprioceptive TrainingA set of proprioceptive exercises oriented to improve balance abilities | Other | Control Group, Experimental Group |
Primary outcome
Berg Balance Scale
Time frame: Change from baseline to end of intervention (one month)
This is a 14 item scale used to assess the overall state of balance of the oder adult
3 secondary outcomes
Test Up and Go
Time frame: Change from baseline to end of intervention (one month)
Pressure Platform Outcome
Time frame: Change from baseline to end of intervention (one month)
Range of Movement
Time frame: Change from baseline to end of intervention (one month)
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 8 Jun 2018.
- 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, PT principal investigator
University of Valencia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feet and Ankle Mobilization and Proprioceptive Training in people with Aging Problems, run by University of Valencia at 2 sites 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 2 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 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Berg Balance Scale (time frame: Change from baseline to end of intervention (one month)). 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 8 Jun 2018.