Flexor Digitorum Profundus Injury Clinical Trial
Official title:
Mobile Application for Improving Rehabilitation After Flexor Tendon Repair - A Randomized Controlled Multicenter Trial.
| Verified date | August 2019 |
| Source | Karolinska Institutet |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 101 |
| Est. completion date | May 10, 2019 |
| Est. primary completion date | May 10, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Department of hand surgery, Skåne university hospital | Malmö | |
| Sweden | Department of hand surgery, University hospital Örebro | Örebro | |
| Sweden | Department of hand surgery, Södersjukshuset | Stockholm | |
| Sweden | Department of hand surgery, Uppsala university hospital | Uppsala |
| Lead Sponsor | Collaborator |
|---|---|
| Karolinska Institutet |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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) | |
| Other | 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) | |
| Primary | Sport injury adherence scale (SIRAS) | Physiotherapist rated adherence questionnaire | assessed at 2 weeks (totalt score range 3-15, higher value indicates better outcome) | |
| Primary | Sport injury adherence scale (SIRAS) | Physiotherapist rated adherence questionnaire | assessed at 6 weeks (totalt score range 3-15, higher value indicates better outcome) | |
| Secondary | Self reported adherence | Patient rated adherence questionnaire duration | assessed at 2 and 6 weeks (total score range 0-100,higher value indicates better outcome ) | |
| Secondary | Self reported adherence | Patient rated adherence questionnaire frequency | assessed at 2 and 6 weeks (total score range 0-100,higher value indicates better outcome ) | |
| Secondary | Self reported adherence | Patient rated adherence questionnaire quality | assessed at 2 and 6 weeks (total score range 0-100, higher value indicates better outcome) | |
| Secondary | Athlet injury self efficacy questionnaire (AISEQ) | Patient reported self efficacy for rehabilitation | baseline, 2 and 6 weeks (Change over time) | |
| Secondary | 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 ) |