Chronic Ankle InstabilityNCT03849547
Evaluation for the Effect of Smartphone Based Training on Chronic Ankle Instability Subjects
A study testing App Balance training and Home Balance training in people with Chronic Ankle Instability, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Chronic Ankle Instability
- What is being tested?
- App Balance training and Home Balance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Feb 2019to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- App Balance training, Home Balance training
- Keywords
- Chronic ankle instability, Smartphone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App Balance trainingOther
Training specially designed for balance ability of chronic ankle instability groups.
Guidance through smartphone application as home program.
Home Balance trainingOther
Training specially designed for balance ability of chronic ankle instability groups.
Follow the usual home program provided in clinics.
| Study group | Role | What they receive |
|---|---|---|
| App training group | Experimental | Subjects in App training group will receive App Balance training via smartphone application. Receives: Other: App Balance training |
| Home training group | Active comparator | Subjects in Home training group will receive Home Balance training advised by physical therapist. Receives: Other: Home Balance training |
| Control group | No intervention | Control group will receive only education of ankle injury prevention related information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural sway measurement
Using smartphone application and force plate to record the postural sway during single leg stance.
Measured: 30 seconds
Star Excursion Balance Test
To assess the dynamic balance ability of subjects.
Measured: 5 minutes
Secondary outcomes (2)
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.
Measured: 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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start18 Feb 2019
- Primary completion15 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ankle InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Hsu Sung, National Yang Ming Chiao Tung University
- Investigators
- Wen-Hsu Sung, Dr., Study chair, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849547
- Sponsor's protocol ID
- CAItraining
- Status last verified
- Feb 2020
- First submitted
- 20 Feb 2019
- Last updated
- 17 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Smartphone-based System for Training Subjects With Chronic Ankle Instability and Training Effect Evaluation
- ClinicalTrials.gov ID
- NCT03849547
- Acronym / sponsor ID
- CAItraining
- Conditions
- Chronic Ankle Instability
- Keywords
- Chronic ankle instability, Smartphone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| App training group | Experimental | Other: App Balance trainingSubjects in App training group will receive App Balance training via smartphone application. |
| Home training group | Active comparator | Other: Home Balance trainingSubjects in Home training group will receive Home Balance training advised by physical therapist. |
| Control group | No intervention | –Control group will receive only education of ankle injury prevention related information. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App Balance trainingTraining specially designed for balance ability of chronic ankle instability groups. Guidance through smartphone application as home program. | Other | App training group |
| Home Balance trainingTraining specially designed for balance ability of chronic ankle instability groups. Follow the usual home program provided in clinics. | Other | Home training group |
Primary outcome
Postural sway measurement
Time frame: 30 seconds
Using smartphone application and force plate to record the postural sway during single leg stance.
Star Excursion Balance Test
Time frame: 5 minutes
To assess the dynamic balance ability of subjects.
2 secondary outcomes
Foot and Ankle Outcome Score
Time frame: 5 minutes
Foot and Ankle Ability Measure-sport subscale
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Individual participant dataSharing planned: No
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The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Hsu Sung, Dr. study chair
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App Balance training and Home Balance training in people with Chronic Ankle Instability, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural sway measurement (time frame: 30 seconds). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.