Dose-response of Anteroposterior Mobilizations in Weight Bearing Talus Dorsiflexion

Aging Problems Clinical Trial

— ANKLE_WBROM  

Official title:

Dose-response of Anteroposterior Mobilizations in Weight Bearing Talus Dorsiflexion in the Older Adult: Allegorized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04563663
• Other study ID #: KTV01
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Aging Problems

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)