Dose-response of Talus Mobilizations

NCT04360512 | Terminated

• 1 other identifier: DHG05
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 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. 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).

Conditions

Aging Problems

Keywords

ROM; Manual therapy; Dose-response; Mobilization; Ankle

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)

Secondary Outcomes (3)

• The Lunge test

  Change from baseline, to end of intervention (2 weeks) and follow-up (10 weeks)

• Active ankle range of motion

  Change from baseline, to end of intervention (2 weeks) and follow-up (10 weeks)

• Timed up and go test (TUG)

  Change from baseline, to end of intervention (2 weeks) and follow-up (10 weeks)

Other Outcomes (1)

• Euro Quality of Life Five Dimensions (EQ-5D)

  Change from baseline, to follow-up (10 weeks)

Study Arms (4)

One session

EXPERIMENTAL

One session of talus posteriorization

Procedure: Posteriorization of the talus

Two sessions

EXPERIMENTAL

Two sessions of talus posteriorization

Procedure: Posteriorization of the talus

Three sessions

EXPERIMENTAL

Three sessions of talus posteriorization

Procedure: Posteriorization of the talus

Four sessions

EXPERIMENTAL

Four sessions of talus posteriorization

Procedure: Posteriorization of the talus

Interventions

Posteriorization of the talus PROCEDURE

Three sets of a 30-s grade IV mobilization

Four sessions; One session; Three sessions; Two sessions

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

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)

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Universidad de Valencia

Valencia, 46010, Spain

Location

Study Officials

• José-María Blasco, PT, PhD

  University of Valencia

  STUDY DIRECTOR

• David Hernández-Guillén, PT, PhD

  University of Valencia

  STUDY CHAIR

• Catalina Tolsada-Velasco, PT

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD

Study Record Dates

• First Submitted: April 18, 2020
• First Posted: April 24, 2020
• Study Start: May 15, 2020
• Primary Completion: May 29, 2020
• Study Completion: September 14, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

ES (1)