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

Chronic Ankle Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03849547
• Other study ID #: CAItraining
• Status: Completed
• Phase: N/A
• Start date: February 18, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: February 2020
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 31, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Ankle Instability
• Joint Instability

Intervention

Other:
• App Balance training
Training specially designed for balance ability of chronic ankle instability groups. Guidance through smartphone application as home program.
• Home Balance training
Training specially designed for balance ability of chronic ankle instability groups. Follow the usual home program provided in clinics.

Locations

Country	Name	City	State
Taiwan	Yang Ming university	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postural sway measurement	Using smartphone application and force plate to record the postural sway during single leg stance.	30 seconds
Primary	Star Excursion Balance Test	To assess the dynamic balance ability of subjects.	5 minutes
Secondary	Foot and Ankle Outcome Score	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.	5 minutes
Secondary	Foot and Ankle Ability Measure-sport subscale	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.	5 minutes