NCT04563663

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2020

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

15 days

First QC Date

September 18, 2020

Last Update Submit

April 27, 2021

Conditions

Keywords

Weight Bearing DorsiflexionManual TherapyAnkleDose-response

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

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

Three sets of a 30-s grade IV anteroposterior mobilization.

Four sessionsOne sessionThree sessionsTwo sessions

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Study Officials

  • José-María Blasco

    University of Valencia

    STUDY DIRECTOR
  • David Hernández-Guillén

    University of Valencia

    PRINCIPAL INVESTIGATOR
  • Catalina Tolsada-Velasco

    University of Valencia

    STUDY CHAIR

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

Locations