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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04210518
Other study ID # UJASB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2, 2019
Est. completion date July 20, 2019

Study information

Verified date December 2019
Source University of Jaén
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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 who received no intervention.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date July 20, 2019
Est. primary completion date July 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- an acute ankle sprain within the last six weeks

- Recent lower limb surgery

Study Design


Intervention

Other:
Neuromuscular training
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
Stroboscopic glasses
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.

Locations

Country Name City State
Spain University of Jaen Jaen

Sponsors (2)

Lead Sponsor Collaborator
University of Jaén University of Miami

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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 Self-reported instability and function To determine the severity of ankle instability the Cumberland ankle instability tool. This questionnaire is a nine items questionnaire ranged from 0 to 30 (0 related with severe impairment and 30 no subjective instability feeling) and has been reported to be a valid tool with high internal consistency and reliability. From baseline to six weeks.
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