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Completed

NCT Number: NCT03849547

Evaluation for the Effect of Smartphone Based Training on Chronic Ankle Instability Subjects

This study aims to verify the training effect of smartphone-based training for chronic ankle instability(CAI) subjects. By randomizing subjects to App training group, clinical training group and control group, the training effect will be compared among groups.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yang Ming university

Taipei, Taiwan

About this study

Postural control ability may be damaged after ankle sprains. Poor postural control ability is the risk factors of the ankle sprain, forming a vicious circle of recurrent sprains. Proper and early assessment is the key to breaking down the circle. Smartphones have been utilized in the medical field. With built-in sensors, utilizing smartphones as assessment tools can provide quantitative data of postural control performance. This study aims to verify the training effect of smartphone-based training for CAI subjects.

CAI subjects were recruited and randomly assigned to App training group, Home training group and control group, receiving 6 weeks of intervention. Pre-test was conducted before the intervention, and the post-test was conducted after the 6-week intervention. The follow up assessment was conducted 4 weeks after the post-test.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least one ankle sprain history
  • At least 2 times of sprain and feeling unstable
  • Diagnosed as functional ankle instability
  • Full recovered from injury
  • Cumberland Ankle Instability Tool<24
  • Ankle Instability Instrument >5 yes
  • Identification of Functional Ankle Instability >11

Exclusion criteria

  • Diagnosis as mechanical instability
  • Neurological deficits
  • Lower extremity injury within the past 6 wk
  • History of lower-extremity surgery
  • Other conditions known to affect balance

Treatment and study plan

App Balance training

Other

Training specially designed for balance ability of chronic ankle instability groups.

Guidance through smartphone application as home program.

Home Balance training

Other

Training specially designed for balance ability of chronic ankle instability groups.

Follow the usual home program provided in clinics.

Primary outcomes

  1. Postural sway measurement

    Time frame: 30 seconds

    Using smartphone application and force plate to record the postural sway during single leg stance.

  2. Star Excursion Balance Test

    Time frame: 5 minutes

    To assess the dynamic balance ability of subjects.

Secondary outcomes

  1. Foot and Ankle Outcome Score

    Time frame: 5 minutes

    An ankle function assessment tool, with 5 dimensions includes symptoms, pain, activity, function and sport, and quality of life.

    The scale score ranges from 0% to 100%, the higher the percentage, the better ankle function. Subjects answer the questions by choosing different choices that describe their condition the best.

    The total score will be summed up and calculated as percentage.

  2. Foot and Ankle Ability Measure-sport subscale

    Time frame: 5 minutes

    An ankle function assessment tool. The scale score ranges from 0% to 100%, the higher the percentage, the better ankle function. Subjects answer the 7 questions by choosing different degree of difficulty to accomplish the activities.

    The total score will be summed up and calculated as percentage.

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study title

Development of a Smartphone-based System for Training Subjects With Chronic Ankle Instability and Training Effect Evaluation

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 21, 2019
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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