NCT03439930

Brief Summary

The goal of this study is evaluate the effect of uni-axial versus multidirectional balance training on muscle reaction time in subjects with chronic ankle instability. Muscle reaction time is measured on a trapdoor simulating an inversion sprain before and after a 6 week lasting balance training protocol.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

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

Study Start

First participant enrolled

September 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

December 1, 2021

Status Verified

November 1, 2021

Enrollment Period

1.3 years

First QC Date

February 14, 2018

Last Update Submit

November 30, 2021

Conditions

Ankle Inversion SprainInstability, JointTreatmentNeuromuscular ControlReaction Time

Outcome Measures

Primary Outcomes (1)

  • muscle reaction time

    Muscle reaction of lower leg muscles is recorded during sudden simulated inversion sprain on a trap door

    6 weeks

Study Arms (2)

Uni-axial

ACTIVE COMPARATOR

Subjects in this group perform exercises on an uni-axial balance board

Other: Balance training

Multidirectional

ACTIVE COMPARATOR

Subjects in this group perform exercises on a multidirectional balance board

Other: Balance training

Interventions

Balance trainingOTHER

6 weeks lasting balance training program

MultidirectionalUni-axial

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • History of an ankle sprain
  • Repetitive ankle sprains AND feelings of instability AND giving way

You may not qualify if:

  • Fracture
  • Surgery
  • equilibrium disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Joint Instability

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Roel De Ridder

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2018

First Posted

February 20, 2018

Study Start

September 1, 2016

Primary Completion

December 31, 2017

Study Completion

June 30, 2018

Last Updated

December 1, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share