NL-OMON53062已完成2 期
ReValidate! The effect of a serious game compared to standard therapy for rehabilitation after distal radius fractures - ReValidate!-trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 93
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •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.
排除标准
- •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.
研究者
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