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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04563663
Other study ID # KTV01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date December 16, 2020

Study information

Verified date April 2021
Source University of Valencia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date December 16, 2020
Est. primary completion date October 16, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - Community-dwelling older adults. - Limited ankle mobility (< 35 degrees). - Over 60 years. 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)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Posteriorization of the talus.
Three sets of a 30-s grade IV anteroposterior mobilization.

Locations

Country Name City State
Spain Universidad de Valencia Valencia

Sponsors (1)

Lead Sponsor Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) . Change from baseline to end of intervention (2 weeks) and follow-up (10 weeks)
Secondary 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) Change from baseline, to end of intervention (2 weeks) and follow-up (10 weeks)
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