Mobile Application for Improving Rehabilitation After Flexor Tendon Repair

NCT03812978 | Completed

• 1 other identifier: FlexortendonsSOS2018
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 4

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.

Conditions

Flexor Digitorum Profundus Injury

Keywords

"Flexor tendon rehabilitation"; "Smart-phone application"; "adherence"

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Self reported adherence

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

• Self reported adherence

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

• Self reported adherence

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

• Athlet injury self efficacy questionnaire (AISEQ)

  baseline, 2 and 6 weeks (Change over time)

• Range of motion

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

Other Outcomes (2)

• Perceived satisfaction with rehabilitation

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

• Perceived satisfaction with information

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

Study Arms (2)

Control

NO INTERVENTION

Standard treatment

Intervention

EXPERIMENTAL

Standard treatment and intervention (Smart phone application)

Other: Smart phone application

Interventions

Smart phone application OTHER

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (4)

Department of hand surgery, Skåne university hospital

Malmo, Sweden

Location

Department of hand surgery, University hospital Örebro

Örebro, Sweden

Location

Department of hand surgery, Södersjukshuset

Stockholm, Sweden

Location

Department of hand surgery, Uppsala university hospital

Uppsala, Sweden

Location

Study Officials

• Marianne Arner, Phd

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 23, 2019
• Study Start: March 1, 2017
• Primary Completion: May 10, 2019
• Study Completion: May 10, 2019
• Last Updated: August 20, 2019

Record last verified: 2019-08

Locations

SE (4)