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

April 22, 2024 updated by: Estoppey Daniel, Hôpital Fribourgeois

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Complete intra-articular DRF (classification AO 23 C1, C2 or C3)
  • Simple palmar operative approach
  • Simple palmar plate fixation
  • Age 18-65 years
  • Worker
  • Own either a smartphone or other wireless device
  • Consent form signed
  • French or German speaker

Exclusion Criteria:

  • Extra-articular or partial-articular DRF
  • Double/triple operative approaches needed
  • Bilateral procedure
  • Fracture aged than more of 2 weeks
  • Patient refusal/no informed consent
  • Inability to give informed consent
  • Previous wrist injury or surgery
  • Rheumatoid polyarthritis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
The group will receive standard hand therapy program + rehabilitation program sustained by the use of a digital application.
Other: Standard hand therapy + home digital application-based exercises
Standard post-operative hand rehabilitation and home digital application-based exercises
Active Comparator: Control group
The control group will receive a standard hand therapy program + paper-based (standard) rehabilitation program.
Other: standard hand therapy + home paper-based exercises
Standard post-operative hand rehabilitation and home paper-based exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion in flexion-extension
Time Frame: From enrollment to the end of treatment at 3 months
Measurement (in degrees) of joint mobility using a goniometer
From enrollment to the end of treatment at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wrist fonction score
Time Frame: From enrollment to the end of treatment at 3 months

Patient-Rated Wrist Evaluation score at 6 and 12 weeks after surgery.

The Patient-Rated Wrist Evaluation score measure the pain score of all 5 items, measure the function score of all the 10 items. The total score the sum of pain and function scores. The best score is 0 and the worst score is 100.
From enrollment to the end of treatment at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Fribourgeois

Investigators

  • Study Director: Thomas TM Mészaros, MD, HFR Fribourg, Hôpital Cantonal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2024

Primary Completion (Actual)

March 15, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

August 9, 2023

First Submitted That Met QC Criteria

August 16, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PhysiAppHFR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be secured and anonymized, and analyzed only by the principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Distal Radius Fracture

Clinical Trials on Standard hand therapy + home digital application-based exercises

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe