NCT04210518

Brief Summary

Balance training with stroboscopic vision in patients with chronic ankle instability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

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

Study Start

First participant enrolled

May 2, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 24, 2019

Completed
Last Updated

December 24, 2019

Status Verified

December 1, 2019

Enrollment Period

2 months

First QC Date

December 8, 2019

Last Update Submit

December 20, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Ankle range of motion

    Ankle dorsiflexion range of motion was assessed by the weight-bearing lunge test. The patient is positioned in a standing position facing a wall with the involved foot parallel with a tape measure which has been attached to the floor and the opposite leg placed behind in a tandem stance. A forward lunge is performed until the anterior knee tries to make contact with the wall with the heel firmly planted on the ground.

    From baseline to six weeks.

  • Dynamic balance

    Dynamic balance has been measured by a simplified version of the Star Excursion Balance Test where the anterior, posteromedial and posterolateral reach directions were collected for statistical analysis.

    From baseline to six weeks.

Secondary Outcomes (1)

  • Self-reported instability and function

    From baseline to six weeks.

Study Arms (3)

Neuromuscular training

EXPERIMENTAL

Neuromuscular training consisting of: * Single limb balance task. * Balance training on an unstable surface. * Hop drills.

Other: Neuromuscular training

Stroboscopic glasses group

EXPERIMENTAL

This group performed the same neuromuscular training with the addition of stroboscopic glasses during the training performance. * Single limb balance task. * Balance training on unstable surfaces. * Hop drills.

Other: Stroboscopic glasses

Control group

NO INTERVENTION

This group received no intervention

Interventions

This intervention consisted of a supervised multimodal exercise protocol addressing different aspects of balance including static and dynamic tasks on the injured ankle. The training program comprised 6 exercises that were progressively adapted depending on the patient's execution controlled by an expert physiotherapist

Neuromuscular training

Patients included in this group performed the same protocol described in the balance training group with the addition of the stroboscopic glasses during the intervention.

Stroboscopic glasses group

Eligibility Criteria

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

You may qualify if:

  • a previous episode of ankle sprain in at least 6 months before the beginning of the study
  • a score of 25 or less in the Cumberland Ankle Instability Tool
  • no history of others musculoskeletal injuries in the lower limbs

You may not qualify if:

  • an acute ankle sprain within the last six weeks
  • Recent lower limb surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jaen

Jaén, 23071, Spain

Location

MeSH Terms

Conditions

Somatosensory Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
An independent assessor blinded to the data collection was responsible for the allocation process. A list of the computer-generated number was employed to assign participants to balance training group, balance training with stroboscopic glasses group or control group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study was a single-blinded randomized controlled trial with two intervention groups consisted in multimodal balance training, multimodal balance training in addition to stroboscopic glasses and control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 8, 2019

First Posted

December 24, 2019

Study Start

May 2, 2019

Primary Completion

July 10, 2019

Study Completion

July 20, 2019

Last Updated

December 24, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations