Dose-response of Anteroposterior Mobilizations in Weight Bearing Talus Dorsiflexion
ANKLE_WBROM
1 other identifier
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2020
CompletedFirst Posted
Study publicly available on registry
September 24, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2020
CompletedApril 28, 2021
April 1, 2021
15 days
September 18, 2020
April 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
The Lunge test
Change from baseline, to end of intervention (2 weeks) and follow-up (10 weeks)
Study Arms (4)
One session
EXPERIMENTALOne session of talus posteriorization.
Two sessions
EXPERIMENTALTwo sessions of talus posteriorization.
Three sessions
EXPERIMENTALThree sessions of talus posteriorization.
Four sessions
EXPERIMENTALFour sessions of talus posteriorization.
Interventions
Three sets of a 30-s grade IV anteroposterior mobilization.
Eligibility Criteria
You may qualify if:
- Community-dwelling older adults.
- Limited ankle mobility (\< 35 degrees).
- Over 60 years.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad de Valencia
Valencia, 46010, Spain
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 18, 2020
First Posted
September 24, 2020
Study Start
October 1, 2020
Primary Completion
October 16, 2020
Study Completion
December 16, 2020
Last Updated
April 28, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share