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CompletedNCT04563663ANKLE_WBROMUpdated Apr 28, 2021

Dose-response of Anteroposterior Mobilizations in Weight Bearing Talus Dorsiflexion

An interventional study of Posteriorization of the talus. in Aging Problems, sponsored by University of Valencia. Completed at 1 site in Spain. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-28.

Sponsored by University of Valencia · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
60 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Aging Problems

Keywords

  • Weight Bearing Dorsiflexion
  • Manual Therapy
  • Ankle
  • Dose-response
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In context

Lead sponsor

University of Valencia is the lead sponsor of 349 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Community-dwelling older adults.
  • Limited ankle mobility (\< 35 degrees).
  • Over 60 years.

Exclusion criteria

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)
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    One session

    One session of talus posteriorization.

    Procedure: Posteriorization of the talus.

  • Experimental
    Two sessions

    Two sessions of talus posteriorization.

    Procedure: Posteriorization of the talus.

  • Experimental
    Three sessions

    Three sessions of talus posteriorization.

    Procedure: Posteriorization of the talus.

  • Experimental
    Four sessions

    Four sessions of talus posteriorization.

    Procedure: Posteriorization of the talus.

Interventions

  • ProcedurePosteriorization of the talus.

    Three sets of a 30-s grade IV anteroposterior mobilization.

06

What researchers measure

Primary outcomes

  1. Treatment dose

    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) .

    Time frame: Change from baseline to end of intervention (2 weeks) and follow-up (10 weeks)

Secondary outcomes

  1. The Lunge test

    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)

    Time frame: Change from baseline, to end of intervention (2 weeks) and follow-up (10 weeks)

07

Study locations

1 site
  • Universidad de Valencia
    Valencia, 46010, Spain
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04563663
Lead sponsor
University of Valencia
Responsible party
David Hernández (Principal Investigator, University of Valencia) — Principal investigator
First posted
Sep 24, 2020
Start date
Oct 1, 2020
Primary completion
Oct 16, 2020
Completion
Dec 16, 2020
Last update
Apr 28, 2021

Study contacts

José-María Blasco
study director · University of Valencia
David Hernández-Guillén
principal investigator · University of Valencia
Catalina Tolsada-Velasco
study chair · University of Valencia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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