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

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ClinicalTrials.gov Identifier: NCT04563663
Recruitment Status : Not yet recruiting
First Posted : September 24, 2020
Last Update Posted : October 9, 2020
Sponsor:
Information provided by (Responsible Party):
David Hernández, University of Valencia

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. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 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
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 16, 2020
Estimated Study Completion Date : December 16, 2020

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.




Primary Outcome Measures :
  1. Treatment dose [ Time Frame: 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 :
  1. The Lunge test [ Time Frame: 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)



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04563663


Contacts
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Contact: José-María Blasco, PhD, PT, Eng +34 963864100 ext 51313 jose.maria.blasco@uv.es
Contact: David Hernández-Guillén, PhD, PT +34 963864100 ext 51313 david.hernandez@uv.es

Locations
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Spain
Universidad de Valencia
Valencia, Spain, 46010
Contact: Jose M Blasco, PhD, PT, Eng    +34963864100    jose.maria.blasco@uv.es   
Contact: David Hernández-Guillén, PhD, PT    +34963864100    david.hernandez@uv.es   
Sub-Investigator: Catalina Tolsada-Velasco, PT         
Sponsors and Collaborators
University of Valencia
Investigators
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Study Director: José-María Blasco University of Valencia
Principal Investigator: David Hernández-Guillén University of Valencia
Study Chair: Catalina Tolsada-Velasco University of Valencia
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Responsible Party: David Hernández, Principal Investigator, University of Valencia
ClinicalTrials.gov Identifier: NCT04563663    
Other Study ID Numbers: KTV01
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Hernández, University of Valencia:
Weight Bearing Dorsiflexion
Manual Therapy
Ankle
Dose-response