NCT03600402

Brief Summary

Limitations of the joint range of the ankle in elderly people is usually common. One of the ways to treat this limitation is through manual therapy, although the effects it produces in dose-response terms are still not well understood. Because of this, this work on the one hand aims to determine the effects and effectiveness of manual therapy and, on the other hand, determine the dose-response necessary for the range of motion of the ankle to improve when applying techniques of manual therapy on the ankle in the older adult.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2019

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

4 months

First QC Date

June 7, 2018

Last Update Submit

January 3, 2019

Conditions

Aging Problems

Keywords

ROMManual TherapyMobilizationAnkle

Outcome Measures

Primary Outcomes (1)

  • Active ankle range of movement

    Measurement of the anterior tilt of the tibia during weight bearing with an inclinometer

    Change from baseline to day 1, 3, 5, 8, 10, 12, 19 and 48

Study Arms (2)

Experimental Group

EXPERIMENTAL
Other: Experimental

Control Group

OTHER
Other: Control

Interventions

ExperimentalOTHER

6 sessions of ankle manual therapy

Experimental Group
ControlOTHER

6 sessions of placebo intervention

Control Group

Eligibility Criteria

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

You may qualify if:

  • Age
  • Ankle dorsiflexion limitation

You may not qualify if:

  • Do not sign the consent
  • No injuries in the foot
  • No acute pathology (3 months) in lower limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

Related Publications (1)

  • Hernandez-Guillen D, Blasco JM. A Randomized Controlled Trial Assessing the Evolution of the Weight-Bearing Ankle Dorsiflexion Range of Motion Over 6 Sessions of Talus Mobilizations in Older Adults. Phys Ther. 2020 Apr 17;100(4):645-652. doi: 10.1093/ptj/pzaa003.

    PMID: 31944252DERIVED

Study Officials

  • David Hernández, PT

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 7, 2018

First Posted

July 26, 2018

Study Start

July 1, 2018

Primary Completion

November 12, 2018

Study Completion

January 3, 2019

Last Updated

January 4, 2019

Record last verified: 2019-01

Locations

ES(1)