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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Ankle Instability
• Intervention / Treatment: Other: App Balance training; Other: Home Balance training

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Yang Ming university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: App training group; Subjects in App training group will receive App Balance training via smartphone application.	Other: App Balance training; Training specially designed for balance ability of chronic ankle instability groups. Guidance through smartphone application as home program.
Active Comparator: Home training group; Subjects in Home training group will receive Home Balance training advised by physical therapist.	Other: Home Balance training; Training specially designed for balance ability of chronic ankle instability groups. Follow the usual home program provided in clinics.
No Intervention: Control group; Control group will receive only education of ankle injury prevention related information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postural sway measurement	Using smartphone application and force plate to record the postural sway during single leg stance.	30 seconds
Star Excursion Balance Test	To assess the dynamic balance ability of subjects.	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: National Yang Ming University
• Investigators: Study Chair: Wen-Hsu Sung, Dr., National Yang Ming University

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2019
• Primary Completion (Actual): January 15, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Smartphone; Chronic ankle instability
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Joint Instability
• Other Study ID Numbers: CAItraining

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No