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

Sponsor

University of Valencia (Other)

Overall Status

Completed

CT.gov ID

NCT04563663

Collaborator

(none)

Enrollment

Location

Arms

2.5

Actual Duration (Months)

24.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aging Problems	Procedure: Posteriorization of the talus.	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Oct 16, 2020

Actual Study Completion Date :

Dec 16, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Treatment dose [Change from baseline to end of intervention (2 weeks) and follow-up (10 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 Outcome Measures

The Lunge test [Change 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad de Valencia	Valencia		Spain	46010

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David Hernández, Principal Investigator, University of Valencia

ClinicalTrials.gov Identifier:

NCT04563663

Other Study ID Numbers:

KTV01

First Posted:

Sep 24, 2020

Last Update Posted:

Apr 28, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by David Hernández, Principal Investigator, University of Valencia

Weight Bearing Dorsiflexion

Manual Therapy

Ankle

Dose-response

Study Results

No Results Posted as of Apr 28, 2021