Old Age; AtrophyNCT05859685
Manual Ankle Therapy on Fear of Falls, Range of Motion, and Functionality and Stability in Geriatric Patients
A study testing Experimental in people with Old Age; Atrophy, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
The range of movement of the ankle decreases with age and the plantar arch decreases, adopting a more pronated position of the foot. The main objective is to analyze the effectiveness of manual therapy using ankle joint techniques in geriatric patients. Randomized, double-blind clinical trial with follow-up period. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Old Age; Atrophy
- What is being tested?
- Experimental
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 6 May 2023to 1 Jul 2023
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Subjects older than 65 years
- Subjects of both sexes
- With impaired balance and gait
- With joint limitation of ankle dorsiflexion
- With established functionality or stability deficits (for example, who need third parties or technical aids to walk (crutches))
Who cannot join
- People with cognitive impairment that prevents their collaboration in the intervention and the different evaluations
- People with inability to stand
- People who have not given their written consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Manual Ankle Therapy on Fear of Falls, Range of Motion, and Functionality and Stability in Geriatric Patients. A Randomized, Double-blind Clinical Study
The range of movement of the ankle decreases with age and the plantar arch decreases, adopting a more pronated position of the foot.
The main objective is to analyze the effectiveness of manual therapy using ankle joint techniques in geriatric patients.
Read more
Randomized, double-blind clinical trial with follow-up period. Subjects will be assigned to control and experimental groups using a data analysis tool (Excel).
The dependent variable will be the fear of falls. The secondary variables will be the range of movement in dorsiflexion of the ankle, and the functionality and stability of the lower limbs.
Three evaluations will be carried out. A baseline measurement before the start of the study (T0), after the intervention (T1) and after a 3-week follow-up period (T2).
A manual therapy protocol will be carried out, lasting 3 weeks with 1 weekly session. Each session will last 10 minutes. The patients included in the experimental group will undergo the following manual therapy techniques: talus dorsal sliding technique and joint technique in "8" on the Lisfranc and Chopart joints. The patients included in the control group underwent the same techniques as those indicated for the experimental group, but without sliding or placing joint tension. The periodicity and times of administration will be the same
- Conditions
- Old Age; Atrophy
- Being tested
- Experimental, Control
- Medical subject headings
- Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Manual therapy techniques:
- Talar dorsal sliding technique. Dorsal mobilization of the talus, with the patient in the supine position and ankle dorsiflexion, without pain or discomfort. The physiotherapist will exercise an anteroposterior mobilization of the talus, with a dorsal glide
- Mulligan movement mobilization technique: The patient will be in a standing position, with the ankle to be treated forward. You will be given an aid or support in the upper extremity to maintain stability.
ControlOther
The patients included in the control group underwent the same techniques as those indicated for the experimental group, but without sliding or placing joint tension. The periodicity and times of administration will be the same
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The patients included in the experimental group will undergo the following manual therapy techniques:
* Talar dorsal sliding technique. A dorsal mobilization of the talus will be performed, with the patient in the supine position and dorsiflexion of the ankle, without pain or discomfort. The physiotherapist will exercise an anteroposterior mobilization of the talus, with a dorsal glide
* Mulligan movement mobilization technique: The patient will be in a standing position, with the ankle to be treated forward. You will be given an aid or support in the upper extremity to maintain stability. Receives: Other: Experimental |
| Control group | Placebo comparator | The patients included in the control group underwent the same techniques as those indicated for the experimental group, but without sliding or placing joint tension. The periodicity and times of administration will be the same Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline fear of falls after treatment and at 3 three weeks
With the Short Falls Efficacy Scale-International, the confidence and ability of a person to avoid a fall while performing basic activities of daily living will be evaluated. The Spanish version of this instrument has shown high reliability (α>0.87). It consists of 7 items with a score of 7 to 28 points (higher scores indicate less confidence and ability).
Measured: Screening visit, within the first seven days after treatment and after three weeks follow-up
Secondary outcomes (3)
Change from baseline ankle range of motion after treatment and at 3 three weeks
The range of movement of the ankle will be measured with a goniometer, following the protocol of Martin et al. The axis will be placed at the lower vertex of the lateral malleolus, the fixed arm parallel to the longitudinal midline of the leg and the mobile arm parallel to the longitudinal midline of the fifth metatarsal. This instrument has shown high reliability (ICCC=0.8-0.9). The higher the graduation, the greater range of motion
Measured: Screening visit, within the first seven days after treatment and after three weeks follow-up
Change from baseline biomechanical analysis of gait and balance after treatment and at 3 three weeks
It will be evaluated with an Rs Scan® pressure platform and FootScan® pressure measurement system. This device measures plantar pressure using an X-Y array of resistive pressure sensitive sensors that are sequentially scanned. The system records pressure data when the subject is standing or walking on the platform. The measurements will be made with the basic platform of 0.5m with 4096 sensors with resistive technology and 300Hz data acquisition frequency. The biomechanics of gait will be analyzed with the analysis of the probes and the static balance in a time of 30 seconds.
Measured: Screening visit, within the first seven days after treatment and after three weeks follow-up
Change from baseline functionality after treatment and at 3 three weeks
The 2-Minutes Walking Test (2MWT) will be used. It will be carried out in a closed corridor, with a length of 30 m delimited between cones. Before the test, participants must rest for at least 10 minutes. Subsequently, they will be told that they must walk the circuit around the cones as fast as possible, but without running, for 2 minutes. They will be allowed to use aids to walk, slow down or stop to rest if necessary. The distance traveled at the end of the 2 minutes will be recorded by the evaluator. This instrument has shown excellent test-retest reliability (ICC = 0.97)
Measured: Screening visit, within the first seven days after treatment and after three weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start6 May 2023
- Primary completion3 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old Age; AtrophyStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubén Cuesta-Barriuso, PhD, Universidad Católica San Antonio de Murcia
- Investigators
- Rubén Cuesta-Barriuso, PhD, Study director, Universidad de Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859685
- Sponsor's protocol ID
- RoM-Ankle
- Status last verified
- May 2023
- First submitted
- 5 May 2023
- Last updated
- 17 May 2024
- 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 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Manual Ankle Therapy on Fear of Falls, Range of Motion, and Functionality and Stability in Geriatric Patients. A Randomized, Double-blind Clinical Study
- ClinicalTrials.gov ID
- NCT05859685
- Acronym / sponsor ID
- RoM-Ankle
- Conditions
- Old Age; Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 6 May 2023 (actual)
- Primary completion
- 3 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 16 May 2023 (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 range of movement of the ankle decreases with age and the plantar arch decreases, adopting a more pronated position of the foot.
The main objective is to analyze the effectiveness of manual therapy using ankle joint techniques in geriatric patients.
Randomized, double-blind clinical trial with follow-up period. Subjects will be assigned to control and experimental groups using a data analysis tool (Excel).
The dependent variable will be the fear of falls. The secondary variables will be the range of movement in dorsiflexion of the ankle, and the functionality and stability of the lower limbs.
Three evaluations will be carried out. A baseline measurement before the start of the study (T0), after the intervention (T1) and after a 3-week follow-up period (T2).
A manual therapy protocol will be carried out, lasting 3 weeks with 1 weekly session. Each session will last 10 minutes. The patients included in the experimental group will undergo the following manual therapy techniques: talus dorsal sliding technique and joint technique in "8" on the Lisfranc and Chopart joints. The patients included in the control group underwent the same techniques as those indicated for the experimental group, but without sliding or placing joint tension. The periodicity and times of administration will be the same
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: ExperimentalThe patients included in the experimental group will undergo the following manual therapy techniques: * Talar dorsal sliding technique. A dorsal mobilization of the talus will be performed, with the patient in the supine position and dorsiflexion of the ankle, without pain or discomfort. The physiotherapist will exercise an anteroposterior mobilization of the talus, with a dorsal glide * Mulligan movement mobilization technique: The patient will be in a standing position, with the ankle to be treated forward. You will be given an aid or support in the upper extremity to maintain stability. |
| Control group | Placebo comparator | Other: ControlThe patients included in the control group underwent the same techniques as those indicated for the experimental group, but without sliding or placing joint tension. The periodicity and times of administration will be the same |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Subjects older than 65 years
- Subjects of both sexes
- With impaired balance and gait
- With joint limitation of ankle dorsiflexion
- With established functionality or stability deficits (for example, who need third parties or technical aids to walk (crutches))
Key exclusion criteria (3 listed)
- People with cognitive impairment that prevents their collaboration in the intervention and the different evaluations
- People with inability to stand
- People who have not given their written consent.
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 |
|---|---|---|
| ExperimentalManual therapy techniques: * Talar dorsal sliding technique. Dorsal mobilization of the talus, with the patient in the supine position and ankle dorsiflexion, without pain or discomfort. The physiotherapist will exercise an anteroposterior mobilization of the talus, with a dorsal glide * Mulligan movement mobilization technique: The patient will be in a standing position, with the ankle to be treated forward. You will be given an aid or support in the upper extremity to maintain stability. | Other | Experimental group |
| ControlThe patients included in the control group underwent the same techniques as those indicated for the experimental group, but without sliding or placing joint tension. The periodicity and times of administration will be the same | Other | Control group |
Primary outcome
Change from baseline fear of falls after treatment and at 3 three weeks
Time frame: Screening visit, within the first seven days after treatment and after three weeks follow-up
With the Short Falls Efficacy Scale-International, the confidence and ability of a person to avoid a fall while performing basic activities of daily living will be evaluated. The Spanish version of this instrument has shown high reliability (α>0.87). It consists of 7 items with a score of 7 to 28 points (higher scores indicate less confidence and ability).
3 secondary outcomes
Change from baseline ankle range of motion after treatment and at 3 three weeks
Time frame: Screening visit, within the first seven days after treatment and after three weeks follow-up
Change from baseline biomechanical analysis of gait and balance after treatment and at 3 three weeks
Time frame: Screening visit, within the first seven days after treatment and after three weeks follow-up
Change from baseline functionality after treatment and at 3 three weeks
Time frame: Screening visit, within the first seven days after treatment and after three weeks follow-up
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 17 May 2024.
- 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.
Rubén Cuesta-Barriuso, PhD study director
Universidad de Oviedo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Old Age; Atrophy, run by Universidad Católica San Antonio de Murcia 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 5 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 17 May 2024. 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. Some participants in this study may receive a placebo. 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?
Change from baseline fear of falls after treatment and at 3 three weeks (time frame: Screening visit, within the first seven days after treatment and after three weeks follow-up). 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 17 May 2024.