App-based Exercise Intervention for Persons With Acute Ankle Sprain
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|ClinicalTrials.gov Identifier: NCT03550274|
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : January 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ankle Sprains||Device: App-based exercise rehabilitation||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Mixed method pilot cohort study|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Investigating the Use and Preliminary Effect of the App "Injury-map" in Providing Exercise Rehabilitation for Persons With Acute Lateral Ankle Sprains Seen at the Emergency Department - a Mixed-method Pilot Study|
|Actual Study Start Date :||July 3, 2018|
|Estimated Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||August 31, 2019|
Experimental: App-based exercise rehabilitation
Persons with Acute lateral ankle sprain (<48 hours) evaluated by a relevant health specialist in the hospital Emergency Department.
Device: App-based exercise rehabilitation
App-based exercise rehabilitation available on any mobile device and/or tablet using Android or iOS operating systems. The app Injurymap© is hosting the exercise program. The app requires user-registrations and a monthly paid subscription fee to access the exercise program. The participants in this study will not be charged for using the app.
The exercise program consists of three phases with increasing difficulty. Each phase consists of several categories of exercise types. The categories are 1) mobility, 2) stability/balance, 3) strength and 4) stretching. Within each phase, there can be more than one exercise for each category. This makes it possible to adjust the difficulty of the exercises depending on user-feedback.
- Return to work [ Time Frame: Four months from ankle injury ]Number of whole days absent from work due to the ankle injury
- Return to sport [ Time Frame: Four months from ankle injury ]Number of exercise sessions not able to fully attend due to the ankle injury
- Re-injuries in the same ankle [ Time Frame: Four months from ankle injury ]Total number of re-sprains categorized into two groups. 1) Ankle sprains with no time loss and 2) ankle sprains with time-loss defined as unable to continue current activity and/or unable to participate in work/sport activities the next days because of the ankle.
- Subjective feeling of ankle stability [ Time Frame: Every week from ankle injury until four months after ]0-10 points, where 0 is completely stable and 10 is very unstable. The participant writes a number within the indicated range that equates to their subjective feeling of stability.
- Subjective feeling of recovery [ Time Frame: Four months from ankle injury ]Do you feel able to do the same activities on the same level as before the injury. answer: YES or NO.
- Recruitment rate: Number of potentially eligible participants at the Emergency Department [ Time Frame: From start of recruitment to the minimum of 60 participants has been achieved, but maximum 3 months ]Database search off registered ankle injuries at the Emergency Department in the recruitment period
- Recruitment rate: Number of persons contacted by the health specialist for information about the study [ Time Frame: From start of recruitment to the minimum of 60 participants has been achieved, but maximum 3 months ]Number of delivered recruitment bags containing project information and rubber bands by the health personel at the Emergency Department.
- Recruitment rate: Number of persons willing to participate. [ Time Frame: From start of recruitment to the minimum of 60 participants has been achieved, but maximum 3 months ]Number of participants who contacts the project administration for participation in the exercise project.
- Recruitment rate: Number of persons commencing the exercise program. [ Time Frame: From start of recruitment to two weeks after the minimum of 60 participants has been achieved, but maximum 3 months and two weeks. ]Number of participants included in the project who commence the exercise program.
- Retention rate: Number of persons completing follow-up assessment. [ Time Frame: Four months from ankle injury ]The number of participants completing the four month follow-up questionnaire of the total number included participants.
- Retention rate: Number of sms responded. [ Time Frame: Four months from ankle injury ]The number of sms responded of the total number of sms send.
- Adherence to exercise program: Number of exercise sessions completed. [ Time Frame: Four months from ankle injury ]The number of sessions completed is extracted from the app database.
- Adherence to exercise program: Number of weeks with minimum one exercise session. [ Time Frame: Four months from ankle injury ]The number of sessions completed in each week is extracted from the app database.
- semi-structured interviews [ Time Frame: two weeks after ended intervention but maximum 4 months and two weeks after the initial ankle injury. ]To uncover user experiences with the app-based exercise program.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550274
|Contact: Jonas Bak, MScfirstname.lastname@example.org|
|Contact: Thomas Q. Bandholm, Prof.||+email@example.com|
|Hvidovre University Hospital||Recruiting|
|Copenhagen, Hvidove, Denmark, 2650|
|Contact: Mette B. Lindstrøm 38623308 firstname.lastname@example.org|
|Principal Investigator:||Jonas Bak, MSc||Hvidovre University Hospital|