Flexor Digitorum Profundus InjuryNCT03812978
Mobile Application for Improving Rehabilitation After Flexor Tendon Repair
A study testing Smart phone application in people with Flexor Digitorum Profundus Injury, run by Karolinska Institutet at 4 sites in Sweden.
Trial summary
Can a mobile application improve adherence, self-efficacy and range of motion after flexor tendon repair? A randomized controlled multicenter trial. Aim Evaluate how the use of a mobile application will affect exercise adherence, range of motion and self-efficacy when compared to standard rehabilitation after flexor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flexor Digitorum Profundus Injury
- What is being tested?
- Smart phone application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 4 sitesSweden
- Study dates
- 1 Mar 2017to 10 May 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old,
- Own a mobile phone, fluent in Swedish,
- Suited for early active motion rehabilitation
- Injury to one or both of the flexor tendons in the a finger
Who cannot join
- concomitant fracture in the hand
- tendon injury to flexor pollicis longus.
- Extensor tendon injury in the same hand.
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Department of hand surgery, Skåne university hospital
Malmö
Department of hand surgery, University hospital Örebro
Örebro
Department of hand surgery, Södersjukshuset
Stockholm
Department of hand surgery, Uppsala university hospital
Uppsala
About this study
Official title: Mobile Application for Improving Rehabilitation After Flexor Tendon Repair - A Randomized Controlled Multicenter Trial.
Can a mobile application improve adherence, self-efficacy and range of motion after flexor tendon repair? A randomized controlled multicenter trial.
Aim Evaluate how the use of a mobile application will affect exercise adherence, range of motion and self-efficacy when compared to standard rehabilitation after flexor tendon repair. Method Multicenter randomized controlled trial. Patients with flexor tendon repair in zone I or II were included and rehabilitated with early active motion and followed 12 weeks post-surgery. Randomization was performed by a computer-generated concealed block to control (n=60) or intervention group (n=60). Both groups received standard rehabilitation according to early active motion. Intervention group also received a smart phone app including; exercise videos, push-notifications for exercise, exercise diary, written information on the surgery, rehabilitation, questions and answers. Evaluation was made at baseline, 2, 6- and 12-weeks after surgery. Primary outcome was physiotherapist rated adherence on the Sport Injury Adherence Scale (SIRAS). Secondary outcome was self-reported adherence, perceived self-efficacy, total Active range of motion (TAM) in the Proximal Interphalangeal (PIP) joint and Distal Interphalangeal (DIP) joint and perceived satisfaction with rehabilitation and information.
- Conditions
- Flexor Digitorum Profundus Injury
- Being tested
- Smart phone application
- Keywords
- "Flexor tendon rehabilitation", "Smart-phone application", "adherence"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart phone applicationOther
Smart phone application including exercise videos, push notifications for exercise, questions and answers, exercise diary.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard treatment |
| Intervention | Experimental | Standard treatment and intervention (Smart phone application) Receives: Other: Smart phone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sport injury adherence scale (SIRAS)
Physiotherapist rated adherence questionnaire
Measured: assessed at 2 weeks (totalt score range 3-15, higher value indicates better outcome)
Sport injury adherence scale (SIRAS)
Physiotherapist rated adherence questionnaire
Measured: assessed at 6 weeks (totalt score range 3-15, higher value indicates better outcome)
Secondary outcomes (5)
Self reported adherence
Patient rated adherence questionnaire duration
Measured: assessed at 2 and 6 weeks (total score range 0-100,higher value indicates better outcome )
Self reported adherence
Patient rated adherence questionnaire frequency
Measured: assessed at 2 and 6 weeks (total score range 0-100,higher value indicates better outcome )
Self reported adherence
Patient rated adherence questionnaire quality
Measured: assessed at 2 and 6 weeks (total score range 0-100, higher value indicates better outcome)
Athlet injury self efficacy questionnaire (AISEQ)
Patient reported self efficacy for rehabilitation
Measured: baseline, 2 and 6 weeks (Change over time)
Range of motion
Total range of motion in the proximal interphalangeal and distal interphalangeal joints measured with a finger goniometer
Measured: assessed at 12 weeks (range 0-240,higher value indicates better outcome )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start1 Mar 2017
- Primary completion10 May 2019
- Study completion10 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexor Digitorum Profundus InjuryStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Arner, Karolinska Institutet
- Investigators
- Marianne Arner, Phd, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812978
- Sponsor's protocol ID
- FlexortendonsSOS2018
- Status last verified
- Aug 2019
- First submitted
- 15 Jan 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Application for Improving Rehabilitation After Flexor Tendon Repair - A Randomized Controlled Multicenter Trial.
- ClinicalTrials.gov ID
- NCT03812978
- Acronym / sponsor ID
- FlexortendonsSOS2018
- Conditions
- Flexor Digitorum Profundus Injury
- Keywords
- "Flexor tendon rehabilitation", "Smart-phone application", "adherence"
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 23 Jan 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.
Can a mobile application improve adherence, self-efficacy and range of motion after flexor tendon repair? A randomized controlled multicenter trial.
Aim Evaluate how the use of a mobile application will affect exercise adherence, range of motion and self-efficacy when compared to standard rehabilitation after flexor tendon repair. Method Multicenter randomized controlled trial. Patients with flexor tendon repair in zone I or II were included and rehabilitated with early active motion and followed 12 weeks post-surgery. Randomization was performed by a computer-generated concealed block to control (n=60) or intervention group (n=60). Both groups received standard rehabilitation according to early active motion. Intervention group also received a smart phone app including; exercise videos, push-notifications for exercise, exercise diary, written information on the surgery, rehabilitation, questions and answers. Evaluation was made at baseline, 2, 6- and 12-weeks after surgery. Primary outcome was physiotherapist rated adherence on the Sport Injury Adherence Scale (SIRAS). Secondary outcome was self-reported adherence, perceived self-efficacy, total Active range of motion (TAM) in the Proximal Interphalangeal (PIP) joint and Distal Interphalangeal (DIP) joint and perceived satisfaction with rehabilitation and information.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard treatment |
| Intervention | Experimental | Other: Smart phone applicationStandard treatment and intervention (Smart phone application) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years old,
- Own a mobile phone, fluent in Swedish,
- Suited for early active motion rehabilitation
- Injury to one or both of the flexor tendons in the a finger
Key exclusion criteria (3 listed)
- concomitant fracture in the hand
- tendon injury to flexor pollicis longus.
- Extensor tendon injury in the same hand.
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 |
|---|---|---|
| Smart phone applicationSmart phone application including exercise videos, push notifications for exercise, questions and answers, exercise diary. | Other | Intervention |
Primary outcome
Sport injury adherence scale (SIRAS)
Time frame: assessed at 2 weeks (totalt score range 3-15, higher value indicates better outcome)
Physiotherapist rated adherence questionnaire
Sport injury adherence scale (SIRAS)
Time frame: assessed at 6 weeks (totalt score range 3-15, higher value indicates better outcome)
Physiotherapist rated adherence questionnaire
5 secondary outcomes
Self reported adherence
Time frame: assessed at 2 and 6 weeks (total score range 0-100,higher value indicates better outcome )
Self reported adherence
Time frame: assessed at 2 and 6 weeks (total score range 0-100,higher value indicates better outcome )
Self reported adherence
Time frame: assessed at 2 and 6 weeks (total score range 0-100, higher value indicates better outcome)
Athlet injury self efficacy questionnaire (AISEQ)
Time frame: baseline, 2 and 6 weeks (Change over time)
Range of motion
Time frame: assessed at 12 weeks (range 0-240,higher value indicates better outcome )
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 20 Aug 2019.
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.
Marianne Arner, Phd principal investigator
Karolinska Institutet
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart phone application in people with Flexor Digitorum Profundus Injury, run by Karolinska Institutet at 4 sites in Sweden.
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 4 inclusion and 3 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 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. 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?
Sport injury adherence scale (SIRAS) (time frame: assessed at 2 weeks (totalt score range 3-15, higher value indicates better outcome)). 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 20 Aug 2019.