Physiotherapy vs Telerehabilitation After Volar Plating of Distal Radius Fracture

NCT06365710 | Recruiting

• 1 other identifier: HUS/206/2022
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Orthopedic Procedures; Physical Therapy Modalities; Postoperative Care; Rehabilitation; Wrist Fractures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Grip strength

  12 months

• Quick Disabilities of the arm, shoulder, and hand

  12 months

• Pain (Visual Analogue Scale)

  12 months

• Wrist range of motion (ROM)

  12 months

• Adverse events

  12 months

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

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

Traditional Physiotherapy

ACTIVE COMPARATOR

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

Interventions

Telerehabilitation OTHER

Telerehabilitation program

Telerehabilitation

Traditional physiotherapy OTHER

Guided rehabilitation program with physiotherapist appointments

Traditional Physiotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Töölö Hospital: lead

Study Sites (1)

Division of Musculosceletal and Plastic Surgery, Hand Surgery Unit, Helsinki University Hospital

Helsinki, Uusimaa, 00029, Finland

RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Central Study Contacts

Samuli Aspinen, M.D.,Ph.D.

CONTACT

+358406360546; samuli.aspinen@hus.fi

Turkka Anttila, M.D.

CONTACT

turkka.anttila@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 15, 2024
• Study Start: November 24, 2022
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2026
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 10 years
• 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

Locations

FI (1)