Mobile Application for Improving Rehabilitation After Flexor Tendon Repair

Not Applicable

Completed

• Conditions: Flexor Digitorum Profundus Injury
• Interventions: Other: Smart phone application

• Registration Number: NCT03812978
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-18
• Study First Posted: 2019-01-23
• Primary Completion: 2019-05-10
• Study Completion: 2019-05-10
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Smart phone application	Standard treatment and intervention (Smart phone application)

Primary Outcome Measures

Name	Time	Method
Sport injury adherence scale (SIRAS)	assessed at 6 weeks (totalt score range 3-15, higher value indicates better outcome)	Physiotherapist rated adherence questionnaire

Secondary Outcome Measures

Name	Time	Method
Self reported adherence	assessed at 2 and 6 weeks (total score range 0-100, higher value indicates better outcome)	Patient rated adherence questionnaire quality
Range of motion	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
Athlet injury self efficacy questionnaire (AISEQ)	baseline, 2 and 6 weeks (Change over time)	Patient reported self efficacy for rehabilitation

Trial Locations

Locations (4)

Department of hand surgery, Södersjukshuset; 🇸🇪 Stockholm, Sweden

Department of hand surgery, University hospital Örebro; 🇸🇪 Örebro, Sweden

Department of hand surgery, Skåne university hospital; 🇸🇪 Malmö, Sweden

Department of hand surgery, Uppsala university hospital; 🇸🇪 Uppsala, Sweden