ReValidate! The effect of a serious game compared to standard therapy for rehabilitation after distal radius fractures
- Conditions
- wrist fractureDistal radius fracture10017322
- Registration Number
- NL-OMON53062
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 93
1. Any type of closed distal radius fracture with no injury to the skin of the
affected limb.
2. Good position after reposition or operative fixation, defined by <10 degrees
of inclination in any direction, <5 mm shortening of the radius compared to the
ulna, <2 mm disposition of intra-articular fragments.
3. Fracture primarily treated with conservative (cast) immobilization or
operative fixation (ORIF).
4. Fracture considered to be consolidated by treating physician (trauma- or
orthopedic surgeon or surgical resident in training)
5. Possible to start rehabilitation exercises within 5 days after cast removal
or operative fixation, as judged by treating physician (trauma- or orthopedic
surgeon or surgical resident in training)
6. Age >= 18 years.
7. Written informed consent.
1. Polytraumatized patients (Injury Severity Score >=16).
2. Bilateral wrist fractures or other injuries to the affected limb.
3. Patients with other disease or injury affecting use of wrist or range of
motion (including Parkinson*s disease, having had a cerebral vascular accident,
amyotrophic lateral sclerosis, neuropathy of any kind)
4. Previous fractures or any condition affecting the injured wrist with
residual pain, loss of function or range of motion.
5. Any medical contra-indication to start rehabilitation within 5 days after
operation or cast removal, as decided by the treating specialist.
6. Insufficient proficiency of Dutch or English in speech and written language,
or inability to complete the Dutch questionnaires.
7. Not in the possession of, or able to obtain for the duration of our study, a
smartphone compatible with our serious game.
8. Visual impairment preventing proper use of the smartphone-based game.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the change in functional outcome between baseline and<br /><br>follow-up as measured by the self-reported Patient-Rated Wrist Evaluation<br /><br>(PRWE) scores. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are the active and passive range of motion, grip strength,<br /><br>pain, and self-reported treatment adherence.</p><br>