Mobile Application for Improving Rehabilitation After Flexor Tendon Repair

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.

Study Overview

• Status: Completed
• Conditions: Flexor Digitorum Profundus Injury
• Intervention / Treatment: Other: Smart phone application

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden
    • Department of Hand Surgery, Skane University Hospital
  • Stockholm, Sweden
    • Department of hand surgery, Södersjukshuset
  • Uppsala, Sweden
    • Department of hand surgery, Uppsala university hospital
  • Örebro, Sweden
    • Department of hand surgery, University hospital Örebro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sport injury adherence scale (SIRAS)	Physiotherapist rated adherence questionnaire	assessed at 2 weeks (totalt score range 3-15, higher value indicates better outcome)
Sport injury adherence scale (SIRAS)	Physiotherapist rated adherence questionnaire	assessed at 6 weeks (totalt score range 3-15, higher value indicates better outcome)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self reported adherence	Patient rated adherence questionnaire duration	assessed at 2 and 6 weeks (total score range 0-100,higher value indicates better outcome )
Self reported adherence	Patient rated adherence questionnaire frequency	assessed at 2 and 6 weeks (total score range 0-100,higher value indicates better outcome )
Self reported adherence	Patient rated adherence questionnaire quality	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	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	assessed at 12 weeks (range 0-240,higher value indicates better outcome )

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived satisfaction with rehabilitation	questions on a Likert scale regarding satisfaction of rehabilitation. "how do you perceive the rehabilitation after the operation?"	at 12 weeks (range 0-100, higher value indicates better outcome)
Perceived satisfaction with information	questions on a Likert scale regarding satisfaction of information: "how do you perceive the information after the operation?"	at 12 weeks (range 0-100, higher value indicates better outcome)

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Marianne Arner, Phd, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): May 10, 2019
• Study Completion (Actual): May 10, 2019

Study Registration Dates

• First Submitted: January 15, 2019
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: "Flexor tendon rehabilitation"; "Smart-phone application"; "adherence"
• Other Study ID Numbers: FlexortendonsSOS2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No