Dose-response of Talus Mobilizations (ANKLE_ROM)

Dose-response of Posterior Talus Mobilizations on Ankle Range of Motion and Overall Mobility in Older Adults

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. Secondarily, this research will appraise whether a likely improvement in ankle mobility may have an impact on the overall mobility (i.e. gait, get up from a chair).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 42
• 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: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Community-dwelling older adults
• Over 60 years
• Limited ankle dorsiflexion range of motion

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: Prevention
• 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 mobilization
Experimental: Two sessions; Two sessions of talus posteriorization	Procedure: Posteriorization of the talus; Three sets of a 30-s grade IV mobilization
Experimental: Three sessions; Three sessions of talus posteriorization	Procedure: Posteriorization of the talus; Three sets of a 30-s grade IV mobilization
Experimental: Four sessions; Four sessions of talus posteriorization	Procedure: Posteriorization of the talus; Three sets of a 30-s grade IV 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)

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)
Active ankle range of motion	Non-weight bearing active ankle range of motion in the sagittal plane: dorsi to plantarflexion full range of motion. This will be assessed with a telescopic goniometer, with the participant laying in supine with a wedge under the knees to eliminate the tension of the gastrocnemius muscles. Values below 59º indicate limited ankle mobility. The minimal detectable change for this measure has not been well established in literature. A baseline progression over 5.2º will be considered clinically important (Searle, 2018; Konor, 2012)	Change from baseline, to end of intervention (2 weeks) and follow-up (10 weeks)
Timed up and go test (TUG)	A timed test used to assess overall mobility and dynamic balance, in which the time taken to get up from and arm-chair, walk three meters, turn around a cone and come back to sit again, is registered to estimate the functional mobility. We will consider times below 12 s as normal performances in the study populattion, and below 13,5 s as low risk of falling. A baseline change over 2.08 s will be considered clinically important (Donoghue, 2019)	Change from baseline, to end of intervention (2 weeks) and follow-up (10 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Euro Quality of Life Five Dimensions (EQ-5D)	The descriptive system comprises five dimensions to assess health related quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state	Change from baseline, to follow-up (10 weeks)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2020
• Primary Completion (Actual): May 29, 2020
• Study Completion (Actual): September 14, 2020

Study Registration Dates

• First Submitted: April 18, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Dose-response; ROM; Manual therapy; Mobilization; Ankle
• Other Study ID Numbers: DHG05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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