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Dose-response of Talus Mobilizations

Dose-response of Posterior Talus Mobilizations on Ankle Range of Motion and Overall Mobility in Older Adults

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04360512
Acronym
ANKLE_ROM
Enrollment
42
Registered
2020-04-24
Start date
2020-05-15
Completion date
2020-09-14
Last updated
2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging Problems

Keywords

ROM, Manual therapy, Dose-response, Mobilization, Ankle

Brief 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. 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).

Interventions

PROCEDUREPosteriorization of the talus

Three sets of a 30-s grade IV mobilization

Sponsors

University of Valencia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Community-dwelling older adults * Over 60 years * Limited ankle dorsiflexion range of motion

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Treatment doseChange 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) .

Secondary

MeasureTime frameDescription
The Lunge testChange from baseline, to end of intervention (2 weeks) and follow-up (10 weeks)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)
Active ankle range of motionChange from baseline, to end of intervention (2 weeks) and follow-up (10 weeks)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)
Timed up and go test (TUG)Change from baseline, to end of intervention (2 weeks) and follow-up (10 weeks)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)

Other

MeasureTime frameDescription
Euro Quality of Life Five Dimensions (EQ-5D)Change from baseline, to follow-up (10 weeks)The descriptive system comprises five dimensions to assess health related quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026