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Mobile Application for Improving Rehabilitation After Flexor Tendon Repair

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ClinicalTrials.gov Identifier: NCT03812978
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Marianne Arner, Karolinska Institutet

Brief 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.


Condition or disease Intervention/treatment Phase
Flexor Digitorum Profundus Injury Other: Smart phone application Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mobile Application for Improving Rehabilitation After Flexor Tendon Repair - A Randomized Controlled Multicenter Trial.
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
No Intervention: Control
Standard treatment
Experimental: Intervention
Standard treatment and intervention (Smart phone application)
Other: Smart phone application
Smart phone application including exercise videos, push notifications for exercise, questions and answers, exercise diary.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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?"



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT03812978


Contacts
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Contact: Jonas Svingen, MsC +46709360278 jonas.svingen@ki.se

Locations
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Sweden
Department of hand surgery, Skåne university hospital Recruiting
Malmö, Sweden
Contact: Stefan Johansson, MsC         
Department of hand surgery, Södersjukshuset Recruiting
Stockholm, Sweden
Contact: Jonas Svingen, MsC    +4686162000    Tobias.Laurell@ki.se   
Department of hand surgery, Uppsala university hospital Recruiting
Uppsala, Sweden
Contact: Ylva Ylva Foucard Gollbo, MsC         
Department of hand surgery, University hospital Örebro Recruiting
Örebro, Sweden
Contact: Johan Niklasson, MsC         
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Marianne Arner, Phd Karolinska Institutet

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Responsible Party: Marianne Arner, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03812978     History of Changes
Other Study ID Numbers: FlexortendonsSOS2018
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marianne Arner, Karolinska Institutet:
"Flexor tendon rehabilitation"
"Smart-phone application"
"adherence"