Paper- vs Digital Application-based Exercises to Support Rehabilitation After Osteosynthesis of Distal Radius Fracture

Distal Radius Fracture Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

The aims of this study are:

1. 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.

2. 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:

• Patient-Rated Wrist Evaluation score

• Return to work

• Retorn to leisure

• Range of motion in pronation and supination, in radial deviation and ulnar deviation

• Distal radio-ulnar joint stability

• Grip strength

• Key pinch strength

• Tripod pinch strength

• Fracture healing

• Fracture displacement

• Patient satisfaction with exercise support

• Patient participation in rehabilitation

Co-primary endpoint: range of motion (ROM) of the wrist, i.e. measured in degrees in flexion and extension.

Secondary endpoints:

• Clinical scores Patient-Rated Wrist Evaluation (PRWE). The Patient-Rated Wrist Evaluation (PRWE) score is to be completed by the patient himself, validated in French and in German. Pain score is measured by 5 items and function is measured by 10 items. The total score is based on 100 points. The best score is 0 and the worst score is 100.

• Partial sick-leave stoppage

• Total sick-leave stoppage

• Return to principal leisure

• Range of motion in pronation and supination, in radial deviation and ulnar deviation

• Distal radio-ulnar joint stability (compared with the healthy side)

• Grip strength (Hydraulic hand dynamometer JAMAR®), i.e. measured in kilograms

• Key pinch strength (B&L Engineering® Pinch Gauge), i.e. measured in kilograms

• Tripod pinch strength (B&L Engineering® Pinch Gauge), i.e. measured in kilograms

• Fracture healing

• Fracture displacement

• Patient satisfaction with exercise support

• Patient participation in rehabilitation

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:

• Patient-Rated Wrist Evaluation (PRWE)

• Return to work

• Retorn to leisure

• Range of motion in pronation and supination, in radial deviation and ulnar deviation

• Distal radio-ulnar joint stability

• Grip strength

• Key pinch strength

• Tripod pinch strength

• Fracture healing

• Fracture displacement

• Patient satisfaction with exercise support

• Patient participation in rehabilitation ;

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures
• Wrist Fractures

• NCT number: NCT06005857
• Study type: Interventional
• Source: Hôpital Fribourgeois
• Contact: Daniel DE Estoppey
• Phone: 0041 26 306 27 90
• Email: daniel.estoppey@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2024
• Completion date: June 30, 2025