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Balance Training With Stroboscopic Vision

Primary Purpose

Ankle Inversion Sprain, Proprioceptive Disorders

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Neuromuscular training
Stroboscopic glasses
Sponsored by
University of Jaén
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Inversion Sprain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Jaen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Neuromuscular training

Stroboscopic glasses group

Control group

Arm Description

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

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.

This group received no intervention

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 8, 2019
Last Updated
December 20, 2019
Sponsor
University of Jaén
Collaborators
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT04210518
Brief Title
Balance Training With Stroboscopic Vision
Official Title
Influence of Stroboscopic Vision on Balance in Patients With Chronic Ankle Instability
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
July 10, 2019 (Actual)
Study Completion Date
July 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén
Collaborators
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Balance training with stroboscopic vision in patients with chronic ankle instability.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Inversion Sprain, Proprioceptive Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model 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.
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular training
Arm Type
Experimental
Arm Description
Neuromuscular training consisting of: Single limb balance task. Balance training on an unstable surface. Hop drills.
Arm Title
Stroboscopic glasses group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This group received no intervention
Intervention Type
Other
Intervention Name(s)
Neuromuscular training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Stroboscopic glasses
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ankle range of motion
Description
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.
Time Frame
From baseline to six weeks.
Title
Dynamic balance
Description
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.
Time Frame
From baseline to six weeks.
Secondary Outcome Measure Information:
Title
Self-reported instability and function
Description
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.
Time Frame
From baseline to six weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Jaen
City
Jaen
ZIP/Postal Code
23071
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Balance Training With Stroboscopic Vision

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