Clinical trial NCT03812978: Mobile Application for Improving Rehabilitation After Flexor Tendon Repair
Official title: Mobile Application for Improving Rehabilitation After Flexor Tendon Repair - A Randomized Controlled Multicenter Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flexor Digitorum Profundus Injury
Keywords: "Flexor tendon rehabilitation"
"Smart-phone application"
"adherence"
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Sport injury adherence scale (SIRAS)
timeFrame: assessed at 2 weeks (totalt score range 3-15, higher value indicates better outcome)
measure: Sport injury adherence scale (SIRAS)
timeFrame: assessed at 6 weeks (totalt score range 3-15, higher value indicates better outcome)
Secondary outcomes:
measure: Self reported adherence
timeFrame: assessed at 2 and 6 weeks (total score range 0-100,higher value indicates better outcome )
measure: Self reported adherence
timeFrame: assessed at 2 and 6 weeks (total score range 0-100,higher value indicates better outcome )
measure: Self reported adherence
timeFrame: assessed at 2 and 6 weeks (total score range 0-100, higher value indicates better outcome)
measure: Athlet injury self efficacy questionnaire (AISEQ)
timeFrame: baseline, 2 and 6 weeks (Change over time)
measure: Range of motion
timeFrame: assessed at 12 weeks (range 0-240,higher value indicates better outcome )
Other outcomes:
measure: Perceived satisfaction with rehabilitation
timeFrame: at 12 weeks (range 0-100, higher value indicates better outcome)
measure: Perceived satisfaction with information
timeFrame: at 12 weeks (range 0-100, higher value indicates better outcome)
Locations:
city: Malmö
country: Sweden
facility: Department of hand surgery, Skåne university hospital
city: Stockholm
country: Sweden
facility: Department of hand surgery, Södersjukshuset
city: Uppsala
country: Sweden
facility: Department of hand surgery, Uppsala university hospital
city: Örebro
country: Sweden
facility: Department of hand surgery, University hospital Örebro
Study officials:
affiliation: Karolinska Institutet
name: Marianne Arner, Phd
role: PRINCIPAL_INVESTIGATOR
References: