Mobile Application for Improving Rehabilitation After Flexor Tendon Repair

Study Overview
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Brief Summary
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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.

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

Conditions
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Flexor Digitorum Profundus Injury

Intervention / Treatment
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* Other: Smart phone application


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard treatment | |
| Experimental: Intervention<br>Standard treatment and intervention (Smart phone application) | Other: Smart phone application<br>* Smart phone application including exercise videos, push notifications for exercise, questions and answers, exercise diary.<br>|

What is the study measuring?
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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 ) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flexor tendon rehabilitation, Smart-phone application, adherence