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Clinical Trials/NCT03849547
NCT03849547CompletedNot Applicable

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

National Yang Ming Chiao Tung University1 site in 1 country46 target enrollmentStarted: February 18, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
46
Locations
1
Primary Endpoint
Star Excursion Balance Test

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

App training group

Experimental

Subjects in App training group will receive App Balance training via smartphone application.

Intervention: App Balance training (Other)

Home training group

Active Comparator

Subjects in Home training group will receive Home Balance training advised by physical therapist.

Intervention: Home Balance training (Other)

Control group

No Intervention

Control group will receive only education of ankle injury prevention related information.

Outcomes

Primary Outcomes

Star Excursion Balance Test

Time Frame: 5 minutes

To assess the dynamic balance ability of subjects.

Postural sway measurement

Time Frame: 30 seconds

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

Secondary Outcomes

  • Foot and Ankle Outcome Score(5 minutes)
  • Foot and Ankle Ability Measure-sport subscale(5 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Wen-Hsu Sung

Professor

National Yang Ming Chiao Tung University

Study Sites (1)

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