Dose-response of Anteroposterior Mobilizations in Weight Bearing Talus Dorsiflexion (ANKLE_WBROM)

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

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.

Study Overview

• Status: Completed
• Conditions: Aging Problems
• Intervention / Treatment: Procedure: Posteriorization of the talus.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Universidad de Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One session; One session of talus posteriorization.	Procedure: Posteriorization of the talus.; Three sets of a 30-s grade IV anteroposterior mobilization.
Experimental: Two sessions; Two sessions of talus posteriorization.	Procedure: Posteriorization of the talus.; Three sets of a 30-s grade IV anteroposterior mobilization.
Experimental: Three sessions; Three sessions of talus posteriorization.	Procedure: Posteriorization of the talus.; Three sets of a 30-s grade IV anteroposterior mobilization.
Experimental: Four sessions; Four sessions of talus posteriorization.	Procedure: Posteriorization of the talus.; Three sets of a 30-s grade IV anteroposterior mobilization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Study Director: José-María Blasco, University of Valencia; Principal Investigator: David Hernández-Guillén, University of Valencia; Study Chair: Catalina Tolsada-Velasco, University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): October 16, 2020
• Study Completion (Actual): December 16, 2020

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Dose-response; Ankle; Manual Therapy; Weight Bearing Dorsiflexion
• Other Study ID Numbers: KTV01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No