NCT03189784

Brief Summary

Ankle joint self mobilization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

2 active sites

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 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

February 15, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2019

Completed
Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

1 month

First QC Date

June 14, 2017

Last Update Submit

December 8, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • range of motion

    the ankle range of motion will be measured by goniometry.

    from baseline prior to the beginning of the intervention to the completion of the study at four weeks.

Secondary Outcomes (2)

  • dynamic balance

    from baseline prior to the beginning of the intervention to the completion of the study at four weeks.

  • Self reported instability

    from baseline prior to the beginning of the intervention to the completion of the study at four weeks.

Study Arms (2)

mobilization group

EXPERIMENTAL

this group will receive mobilization with movement techniques.

Other: mobilization with movement techniques

Control group

NO INTERVENTION

The control group will receive no intervention

Interventions

patient will receive an anteroposterior stimuli in the talus in order to restore the range of motion

Also known as: Joint mobilizations
mobilization group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ankle range of motion limitation respect the contralateral ankle.
  • At least two episodes of giving way on the affected ankle.
  • Scores of at least 24 in the cumberland ankle instability tool.

You may not qualify if:

  • recent fractures of the involved limb.
  • Vestibular or balance dysfunction.
  • Acute ankle sprain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Jaen campus

Jaén, 23009, Spain

Location

University of Jaen

Jaén, 23071, Spain

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapy coordinator

Study Record Dates

First Submitted

June 14, 2017

First Posted

June 16, 2017

Study Start

February 15, 2018

Primary Completion

March 30, 2018

Study Completion

April 2, 2019

Last Updated

December 10, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations