Cabana François, Pagé Catherine, Svotelis Amy, Langlois-Michaud Samuel, Tousignant Michel
Department of surgery, Faculty of Medicine and Health Sciences, Université de Sherbrooke, 3001 12e Avenue Nord, Sherbrooke, J1H 5N4 QC Canada.
Research Centre on Aging, Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de l'Estrie CHUS), 1036 Belvédère Sud, Sherbrooke, J1H 4C4 QC Canada.
BMC Sports Sci Med Rehabil. 2016 Aug 26;8(1):27. doi: 10.1186/s13102-016-0051-z. eCollection 2016.
Proximal humerus fractures can be treated surgically (eg: pinning, plate and screws) or conservatively by wearing a splint or a cast. Following both of these approaches, rehabilitation has proven effective to prevent functional limitations and to re-establish normal shoulder function. However, access to these rehabilitation services and compliance tends to be limited in elderly patients due to travelling difficulties caused by their precarious health status and, in some cases, social and marital status. Since the majority of patients with a proximal humerus fracture are elderly, it becomes relevant to find a new way to offer quick, simple and suitable rehabilitation service. Thus, the use of promising alternative approaches, as in-home telerehabilitation, can enhance access to rehabilitation services for such population. The main objective of the study is to compare the clinical effects of the innovative telerehabilitation approach (TELE group) compared to face-to-face visits to a clinic (CLINIC group) for patients treated for a proximal humerus fracture.
METHODS/DESIGN: In this randomized controlled trial, individuals who have had a proximal humerus fracture treated conservatively at the Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke (CIUSSS de l'Estrie CHUS), and who are returning home will be included. Participants will be recruited during their visit to the emergency ward or outpatient clinic by the medical or research team and will then sign the informed consent form if they are interested to participate in the study. We expect to recruit 52 participants (26 per group). Randomization will be done by a random number generator with sealed envelopes. Each patient will be evaluated before the beginning of the rehabilitation (T1), and immediately after the 2-month intervention (T2). The following outcomes will be measured: 1) upper extremity function (Constant Shoulder Score and Disability of the Arm, Shoulder and Hand questionnaire [DASH]); 2) range of motion (conventional goniometer); 3) user satisfaction (Health Care Satisfaction questionnaire); and 4) cost of services to the public healthcare system. The difference between the two groups will be compared using a t-test or a chi-squared test, and through a cost-effectiveness economic analysis.
We hypothesize that in-home telerehabilitation will provide a good alternative to conventional rehabilitation, in terms of its efficacy, simplicity, patient satisfaction, and low associated costs.
ClinicalTrials.gov: NCT02425267. April 22(nd), 2015.
肱骨近端骨折可通过手术治疗（如：穿针、钢板和螺钉固定）或通过佩戴夹板或石膏进行保守治疗。采用这两种方法后，康复治疗已被证明对预防功能受限和恢复正常肩部功能有效。然而，由于老年患者健康状况不稳定以及在某些情况下社会和婚姻状况导致的出行困难，他们获得这些康复服务的机会和依从性往往受到限制。由于大多数肱骨近端骨折患者是老年人，因此找到一种提供快速、简单且合适的康复服务的新方法变得很有必要。因此，采用有前景的替代方法，如家庭远程康复，可以增加这类人群获得康复服务的机会。本研究的主要目的是比较创新的远程康复方法（TELE组）与面对面到诊所就诊（CLINIC组）对肱骨近端骨折患者的临床效果。
方法/设计：在这项随机对照试验中，将纳入在东里谢尔综合大学健康与社会服务中心 - 舍布鲁克大学中心医院（CIUSSS de l'Estrie CHUS）接受保守治疗后回家的肱骨近端骨折患者。参与者将在急诊病房或门诊就诊期间由医疗或研究团队招募，如果他们有兴趣参与研究，将签署知情同意书。我们预计招募52名参与者（每组26名）。随机化将通过带有密封信封的随机数生成器进行。每位患者将在康复开始前（T1）以及2个月干预结束后立即（T2）进行评估。将测量以下结果：1）上肢功能（Constant肩关节评分和手臂、肩部和手部残疾问卷[DASH]）；2）活动范围（传统角度计）；3）用户满意度（医疗保健满意度问卷）；4）公共医疗系统的服务成本。两组之间的差异将使用t检验或卡方检验进行比较，并通过成本效益经济分析进行比较。
我们假设家庭远程康复在疗效、简便性、患者满意度和低相关成本方面将为传统康复提供一个很好的替代方案。
ClinicalTrials.gov：NCT02425267。2015年4月22日。
