Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06365710

Physiotherapy vs Telerehabilitation After Volar Plating of Distal Radius Fracture

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Orthopedic Procedures Arm Injuries Fractures, Bone Physical Therapy Modalities Postoperative Care Rehabilitation Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Helsinki, Uusimaa, 00029, Finland

Location status: Recruiting

Location contact

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

CONTACT

[email protected]

+358406360546

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

telerehabilitation

Other

Telerehabilitation program

traditional physiotherapy

Other

Guided rehabilitation program with physiotherapist appointments

Primary outcomes

  1. Patient-Rated Wrist Evaluation (PRWE)

    Time frame: 12 months

    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)

Secondary outcomes

  1. Grip strength

    Time frame: 12 months

    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

  2. Quick Disabilities of the arm, shoulder, and hand

    Time frame: 12 months

    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)

  3. Pain (Visual Analogue Scale)

    Time frame: 12 months

    The VAS is derived by health care professional question of pain in scale 0 to 10 (0=no pain, 10=worst possible pain).

  4. Wrist range of motion (ROM)

    Time frame: 12 months

    Wrist ROM is measured on both wrists with a handheld goniometer in degrees.

  5. Adverse events

    Time frame: 12 months

    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.

  6. Global improvement

    Time frame: 12 months

    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

  7. Patient-rated Quality of Life (EQ-5D)

    Time frame: 12 months

    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).

  8. Cost-utility analysis

    Time frame: 12 months

    Quality-adjusted life years/months measured as a change in EQ-5D

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+358406360546

Turkka Anttila, M.D.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Töölö Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 15, 2024
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.