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

NCT ID: NCT03849547

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-18
• Study Completion Date: 2020-01-31

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.

Conditions

Chronic Ankle Instability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

App training group

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

Group Type: EXPERIMENTAL

App Balance training

Intervention Type: OTHER

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

Guidance through smartphone application as home program.

Home training group

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

Group Type: ACTIVE_COMPARATOR

Home Balance training

Intervention Type: OTHER

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

Follow the usual home program provided in clinics.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

App Balance training

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

Guidance through smartphone application as home program.

Intervention Type: OTHER

Home Balance training

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

Follow the usual home program provided in clinics.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: lead

Responsible Party

Wen-Hsu Sung

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wen-Hsu Sung, Dr.

Role: STUDY_CHAIR

National Yang Ming Chiao Tung University

Locations

Yang Ming university

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

CAItraining

Identifier Type: -

Identifier Source: org_study_id