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
1 other identifier
interventional
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 18, 2019
CompletedFirst Submitted
Initial submission to the registry
February 20, 2019
CompletedFirst Posted
Study publicly available on registry
February 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2020
CompletedFebruary 17, 2020
February 1, 2020
11 months
February 20, 2019
February 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Foot and Ankle Outcome Score
5 minutes
Foot and Ankle Ability Measure-sport subscale
5 minutes
Study Arms (3)
App training group
EXPERIMENTALSubjects in App training group will receive App Balance training via smartphone application.
Home training group
ACTIVE COMPARATORSubjects in Home training group will receive Home Balance training advised by physical therapist.
Control group
NO INTERVENTIONControl group will receive only education of ankle injury prevention related information.
Interventions
Training specially designed for balance ability of chronic ankle instability groups. Guidance through smartphone application as home program.
Training specially designed for balance ability of chronic ankle instability groups. Follow the usual home program provided in clinics.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yang Ming university
Taipei, Taiwan
Study Officials
- STUDY CHAIR
Wen-Hsu Sung, Dr.
National Yang Ming Chiao Tung University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 20, 2019
First Posted
February 21, 2019
Study Start
February 18, 2019
Primary Completion
January 15, 2020
Study Completion
January 31, 2020
Last Updated
February 17, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share