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Completed

NCT Number: NCT03812978

Mobile Application for Improving Rehabilitation After Flexor Tendon Repair

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.

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Key information

Conditions

Flexor Digitorum Profundus Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of hand surgery, Skåne university hospital, Malmö, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Smart phone application

Other

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Self reported adherence

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

    Patient rated adherence questionnaire duration

  2. Self reported adherence

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

    Patient rated adherence questionnaire frequency

  3. Self reported adherence

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

    Patient rated adherence questionnaire quality

  4. Athlet injury self efficacy questionnaire (AISEQ)

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

    Patient reported self efficacy for rehabilitation

  5. Range of motion

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

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

Other outcomes

  1. Perceived satisfaction with rehabilitation

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

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

  2. Perceived satisfaction with information

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

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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Mobile Application for Improving Rehabilitation After Flexor Tendon Repair - A Randomized Controlled Multicenter Trial.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2019
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.