Use of Paper- Versus Digital Application-based Exercises to Support the Rehabilitation of People Operated by a Palmar Plate for an Intra-articular Distal Radius Fracture. A Multidisciplinary, Prospective, Randomized, Single-blind, Controlled Trial
Use of Paper- Versus Digital Application-based Exercises to Support the Rehabilitation of People Operated by a Palmar Plate for an Intra-articular Distal Radius Fracture. A Multidisciplinary, Prospective, Randomized, Single-blind, Controlled Trial
The aim of this study is to evaluate the difference between the use of paper- versus application-based (smartphone application) exercises in the rehabilitation of intra-articular fractures of the distal radius at the Cantonal Hospital of Fribourg, Switzerland.
The operation itself will proceed as usual. However, the rehabilitation will be aided by exercises based either on a paper support or on a digital application (smartphone application), in addition to follow-up by a hand therapist.
The aim is to determine which support provides the best improvement in wrist mobility and function, and to speed up the return to work.
The aims of this study are:
To measure range of motion (flexion and extension) of the wrist in usual post-operative hand therapy sustained by the use of a digital application-based home exercise program compared with usual post-operative hand therapy sustained by the use of paper-based (standard) home exercice program.
To measure the following variables in usual post-operative hand therapy sustained by the use of a digital application-based home exercise program compared with usual post-operative hand therapy sustained by the use of paper-based (standard) home exercice program:
Co-primary endpoint: range of motion (ROM) of the wrist, i.e. measured in degrees in flexion and extension.
Secondary endpoints:
This research is a national, interdisciplinary, prospective, single-blind (investigator), parallel-group (experimental study, level of evidence I), monocentric (conducted at the HFR Fribourg - Hôpital cantonal) study.
All patients will undergo the same operative procedure. Upon arrival to the operating room, patients will be placed in supine position, the injured limb resting on a hand table. Standard anesthetic axillary nerve will be applied. All the operation will do by an experienced hand surgeon having minimum 5 years of post-specialization clinical experience. A standard modified Henry approach will be done. The DRF will be reduced and fixed with a palmar plate (Aptus Adaptive II, Medartis®). The stability of the distal radio ulnar joint (DRUJ) will be tested after the radius fixation. If the DRUJ will be instable, the ulnar styloid fracture will be fixed (osteo suture (PDS wire) or screw fixation (Aptus CCS 1.7/2.2, Medartis®).
The study participants will be allocated (randomization) to either Group 1 (standard hand therapy + home smartphone application-based exercises) or Group 2 (standard hand therapy + home paper-based exercises). The two groups will be matched as good as possible in terms of total numbers of participants per group, age (18-40 years or 41-65 years) and type of work (non-manual work or manual work) in order to minimize any possible bias due to structural differences in both groups.
All patients will undergo the same postoperative splint immobilization (removable palmar custom splint) for 6 weeks.
Patients will be randomly assigned to receive either a standard hand therapy program + smartphone application-based exercises or a standard hand therapy program + paper-based exercises. The follow-up will consist of a one-to-one therapy session per week durung 12 for monitoring, i.e. range of motion, swelling, scar, eventual adverse event, and the way of practicing exercises. In-person sessions will be supervised by a therapist involved in the study, who is certified in hand rehabilitation. Moreover, each patient is expected to practice by himself a daily home exercises program consisting of mobilization of the (i) thumb and (ii) long fingers in flexion-extension and mobilization of the (iii) wrist in flexion-extension, radio-ulnar inclination and pro-supination. Each exercise will be performed in 3 sets of 15 repetitions, 5 times a day. Strengthening exercises (iv) will be added from the sixth week post-surgery. Each training session will last around 15 minutes, and be repeated after a three-hours break. They are standard exercises used in the treatment of DRF and validated by several guidelines. If necessary, the treatment will be pursued after 12 weeks.
Each patient will be asked to fill in a paper daily diary on the number of exercises performed (number of repetitions actually performed per set requested, how many times per day). They will also be asked to fill in the level of pain felt at that time. A satisfaction questionnaire will be completed at the end of the treatment concerning the support (digital vs paper) used.
At 6 and 12 weeks, the blinded surgeon (not aware of the therapy the patient is undergoing) will research any clinical or radiological adverse events.
At 6 and 12 weeks, a blinded independent observer (not aware of the therapy the patient is undergoing) will measure the values required to achieve the aims 1 and 2.
Aim 1 :
An independent observer who is not the surgeon will measure, at 6 and 12 weeks, range of motion (flexion and extension) of patients of both groups (Group 1, with standard hand therapy + home digital application-based exercises; Group 2, with standard hand therapy + home paper-based exercises) with photography (Figure 11) and with a goniometer.
Aim 2 :
Patients of both groups (Group 1, with standard hand therapy + home digital application-based exercises; Group 2, with standard hand therapy + home paper-based exercises), the following variables will be measured:
Inclusion Criteria:
Exclusion Criteria:
daniel.estoppey@gmail.com0041 26 306 27 90
thomas.meszaros@h-fr.ch0041 26 306 27 90