Dose-response of Talus Mobilizations

Study Overview
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Brief Summary
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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).

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

Conditions
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Aging Problems

Intervention / Treatment
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* Procedure: Posteriorization of the talus


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One session<br>One session of talus posteriorization | Procedure: Posteriorization of the talus<br>* Three sets of a 30-s grade IV mobilization<br>|
| Experimental: Two sessions<br>Two sessions of talus posteriorization | Procedure: Posteriorization of the talus<br>* Three sets of a 30-s grade IV mobilization<br>|
| Experimental: Three sessions<br>Three sessions of talus posteriorization | Procedure: Posteriorization of the talus<br>* Three sets of a 30-s grade IV mobilization<br>|
| Experimental: Four sessions<br>Four sessions of talus posteriorization | Procedure: Posteriorization of the talus<br>* Three sets of a 30-s grade IV mobilization<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ROM, Manual therapy, Dose-response, Mobilization, Ankle