Physiotherapy vs Telerehabilitation After Volar Plating of Distal Radius Fracture

A Randomized Controlled Trial Comparing Traditional Physiotherapy vs Telerehabilitation After Volar Plating of Distal Radius Fracture: a Study Protocol

Trial purpose is to research the outcome comparing traditional physiotherapy vs telerehabilitation after volar plating of distal radius fracture.

Patients with distal radius fracture that meet the operative criteria set by the Finnish Current Care guidelines are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo operative treatment and traditional physiotherapy vs telerehabilitation.

Baseline data is collected preoperatively and patients are followed at 1, 3 and 12 months after enrollment. The primary end-point is 3 months and the primary outcome is the Patient-Rated Wrist Evaluation (PRWE).

Study Overview

• Status: Recruiting
• Conditions: Rehabilitation; Postoperative Care; Orthopedic Procedures; Physical Therapy Modalities; Wrist Fractures
• Intervention / Treatment: Other: Telerehabilitation; Other: Traditional physiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samuli Aspinen, M.D.,Ph.D.; Phone Number: +358406360546; Email: samuli.aspinen@hus.fi
• Study Contact Backup: Name: Turkka Anttila, M.D.; Email: turkka.anttila@hus.fi

Study Locations

• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00029
      • Recruiting
      • Division of Musculosceletal and Plastic Surgery, Hand Surgery Unit, Helsinki University Hospital
      • Contact: Samuli Aspinen, M.D., Ph.D.; Phone Number: +358406360546; Email: samuli.aspinen@hus.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Distal radius fracture, which applies the surgical requirements
• age between 18 to 65 years
• Non concomitant injuries including ligament injuries and distal ulna fractures, however ulnar styloid avulsion is accepted
• No significant comorbidities
• No previous problems with the examined hand
• Ability to understand Finnish fluently

Exclusion Criteria:

• High energy or multiple injuries
• Open fractures
• Injury of both upper extremities
• Other operative injury on the same side
• Rheumatoid arthritis of other inflammatory joint disease
• Heavy smoker (over 20 cigarettes per day)
• Disease of medication slowing ossification
• Alcohol or drug abuse
• Psychiatric disorder with poor treatment balance
• Neurological disorder which affects the function of the injured extremity
• Fixation material other than a volar locking plate
• Fracture fixation is not stable enough to start rehabilitation after 14 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telerehabilitation; The telerehabilitation group will start the physiotherapy guided by the digital care pathway postoperatively. The pathway includes videos, photos, animations and written material for rehabilitation of the operated hand. The same weightbearing instructions and mobilization exercises are shown in the videos and photos as are instructed in the physiotherapist appointment in the traditional physiotherapy group.	Other: Telerehabilitation; Telerehabilitation program
Active Comparator: Traditional Physiotherapy; The traditional physiotherapy group will attend appointment with the physiotherapist at two-week and five week timepoints. After this, this group can attend additional physiotherapist appointments if seen necessary by the physiotherapist or the surgeon.	Other: Traditional physiotherapy; Guided rehabilitation program with physiotherapist appointments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Rated Wrist Evaluation (PRWE)	The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global improvement	Global rating to treatment effect will be evaluated by question: "How would you rate the function of your hand compared to the situation before the treatment?". The options are in 5-step Likert scale from (-2) Much worse to (+2) Much better	12 months
Grip strength	Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in kg and percentage of the unaffected side	12 months
Wrist range of motion (ROM)	Wrist ROM is measured on both wrists with a handheld goniometer in degrees.	12 months
Quick Disabilities of the arm, shoulder, and hand	The QuickDASH is self-reported questionnaire and shortened version of DASH outcome measure to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb in 11 dimensions in 1-5 scale (1=best possible outcome, 5=worst possible outcome)	12 months
Pain (Visual Analogue Scale)	The VAS is derived by health care professional question of pain in scale 0 to 10 (0=no pain, 10=worst possible pain).	12 months
Adverse events	Incidence of adverse events (i.e. non-union, fracture, reoperation, infection, iatrogenic tendon/nerve/arterial injury, complex regional pain syndrome, traumatic arthritis) is recorded and compared between study groups.	12 months
Cost-utility analysis	Quality-adjusted life years/months measured as a change in EQ-5D	12 months
Patient-rated Quality of Life (EQ-5D)	EQ-5D is an instrument which evaluates the generic quality of life. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The options are in 5-step scale. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).	12 months

Collaborators and Investigators

• Sponsor: Töölö Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2022
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Wrist Injuries; Wrist Fractures; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: HUS/206/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Public access to the final trial dataset will be available on reasonable request from the principal investigator for research purposes
• IPD Sharing Time Frame: 10 years
• IPD Sharing Access Criteria: Public access to the final trial dataset will be available on reasonable request from the principal investigator for research purposes. Study protocol, SAP and ICF will be pupblished as a part of the study protocol
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No