Orthopedic Procedures, Physical Therapy Modalities, Postoperative Care, Rehabilitation, Wrist Fractures
Conditions
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).
Interventions
OTHERTelerehabilitation
Telerehabilitation program
OTHERTraditional physiotherapy
Guided rehabilitation program with physiotherapist appointments
Sponsors
Töölö Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Rated Wrist Evaluation (PRWE) | 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
| Measure | Time frame | Description |
|---|---|---|
| Quick Disabilities of the arm, shoulder, and hand | 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) |
| Pain (Visual Analogue Scale) | 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). |
| Wrist range of motion (ROM) | 12 months | Wrist ROM is measured on both wrists with a handheld goniometer in degrees. |
| Grip strength | 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 |
| Global improvement | 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 |
| Patient-rated Quality of Life (EQ-5D) | 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). |
| Cost-utility analysis | 12 months | Quality-adjusted life years/months measured as a change in EQ-5D |
| Adverse events | 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. |
Countries
Finland
Contacts
Primary ContactSamuli Aspinen, M.D.,Ph.D.
Backup ContactTurkka Anttila, M.D.
Outcome results
None listed