CClinicalTrials.gg
CompletedNCT03812978Updated Aug 20, 2019

Mobile Application for Improving Rehabilitation After Flexor Tendon Repair

An interventional study of Smart phone application in Flexor Digitorum Profundus Injury, sponsored by Karolinska Institutet. Completed at 4 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-20.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Mar 2017, registered Jan 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
101
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Flexor Digitorum Profundus Injury

Keywords

  • "Flexor tendon rehabilitation"
  • "Smart-phone application"
  • "adherence"
03

In context

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • concomitant fracture in the hand
  • tendon injury to flexor pollicis longus.
  • Extensor tendon injury in the same hand.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
101 participants (actual)

Study arms

  • No intervention
    Control

    Standard treatment

  • Experimental
    Intervention

    Standard treatment and intervention (Smart phone application)

    Other: Smart phone application

Interventions

  • OtherSmart phone application

    Smart phone application including exercise videos, push notifications for exercise, questions and answers, exercise diary.

06

What researchers measure

Primary outcomes

  1. Sport injury adherence scale (SIRAS)

    Physiotherapist rated adherence questionnaire

    Time frame: assessed at 2 weeks (totalt score range 3-15, higher value indicates better outcome)

  2. Sport injury adherence scale (SIRAS)

    Physiotherapist rated adherence questionnaire

    Time frame: assessed at 6 weeks (totalt score range 3-15, higher value indicates better outcome)

Secondary outcomes

  1. Self reported adherence

    Patient rated adherence questionnaire duration

    Time frame: assessed at 2 and 6 weeks (total score range 0-100,higher value indicates better outcome )

  2. Self reported adherence

    Patient rated adherence questionnaire frequency

    Time frame: assessed at 2 and 6 weeks (total score range 0-100,higher value indicates better outcome )

  3. Self reported adherence

    Patient rated adherence questionnaire quality

    Time frame: assessed at 2 and 6 weeks (total score range 0-100, higher value indicates better outcome)

  4. Athlet injury self efficacy questionnaire (AISEQ)

    Patient reported self efficacy for rehabilitation

    Time frame: baseline, 2 and 6 weeks (Change over time)

  5. Range of motion

    Total range of motion in the proximal interphalangeal and distal interphalangeal joints measured with a finger goniometer

    Time frame: assessed at 12 weeks (range 0-240,higher value indicates better outcome )

Other outcomes

  1. Perceived satisfaction with rehabilitation

    questions on a Likert scale regarding satisfaction of rehabilitation. "how do you perceive the rehabilitation after the operation?"

    Time frame: at 12 weeks (range 0-100, higher value indicates better outcome)

  2. Perceived satisfaction with information

    questions on a Likert scale regarding satisfaction of information: "how do you perceive the information after the operation?"

    Time frame: at 12 weeks (range 0-100, higher value indicates better outcome)

07

Study locations

4 sites
  • Department of hand surgery, Skåne university hospital
    Malmö, Sweden
  • Department of hand surgery, Södersjukshuset
    Stockholm, Sweden
  • Department of hand surgery, Uppsala university hospital
    Uppsala, Sweden
  • Department of hand surgery, University hospital Örebro
    Örebro, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03812978
Lead sponsor
Karolinska Institutet
Responsible party
Marianne Arner (Principal Investigator, Karolinska Institutet) — Principal investigator
First posted
Jan 23, 2019
Start date
Mar 1, 2017
Primary completion
May 10, 2019
Completion
May 10, 2019
Last update
Aug 20, 2019

Study contacts

Marianne Arner, Phd
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion