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临床试验/NCT02425267
NCT02425267已完成不适用

Effectiveness of a Home Telerehabilitation Program for People With Proximal Humerus Fracture Treated Conservatively: a Randomized Clinical Trial.

Université de Sherbrooke2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2015年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
2
主要终点
Shoulder function (score /100)

研究概览

简要总结

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.

详细描述

Every year, one out of three elderly people make at least one fall, and 10% of them cause a fracture. Of these fractures, those of the proximal humerus, the forearm and the wrist count for approximately one third of total osteoporotic fractures in elderly people. Proximal humerus fractures can be treated surgically (eg: pinning, plate and screws, etc..) or conventionally by wearing a splint or a cast. Whether either of these approaches, the individual requires rehabilitation to prevent function limitations.

Among the possible reasons for the low use of rehabilitation services, there are 1) poor availability of rehabilitation services for fractures of the humerus; or 2) the difficulty of the elderly to travel to receive these services because of their precarious status. Telerehabilitation is a promising alternative approach that can help improve access to rehabilitation services once patients are discharged from hospital.

Some studies demonstrate that physiotherapy is a significant factor in the process of healing and functional recovery of a proximal humerus fracture, and that, for conservative or surgical treatment. This is showed by the good recovery of patients and by their satisfaction with the physiotherapy. In addition, since the majority of patients with a proximal humerus fracture are elderly, it becomes relevant to find a new way to offer quick service physiotherapy and simple and suitable to their condition.

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.

The research hypothesis are:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Proximal humerus fracture (without surgery)
  • Return home after discharge from hospital
  • Be able to exercise;
  • Have sufficient verbal and written understanding to participate to telerehabilitation sessions, and to be able complete the questionnaires;
  • Have access to high-speed Internet at home.

排除标准

  • Presence of intra-articular type proximal humerus fracture, which can lead to a greater risk of complication and may require a longer recovery time
  • Fracture surgery as a treatment
  • Presence of any other type of upper body fracture which can interfere with rehabilitation.

研究组 & 干预措施

Telerehabilitation

Experimental

Telerehabilitation at home from a clinic

干预措施: Rehabilitation (Physiotherapy) (Other)

Face-to-face intervention in a clinic

Active Comparator

Conventional physiotherapy

干预措施: Rehabilitation (Physiotherapy) (Other)

结局指标

主要结局

Shoulder function (score /100)

时间窗: Pre-intervention: 1 to 3 weeks post fracture (T1) and Post-intervention: after the 8-week intervention (T2)

Constant score

次要结局

  • Satisfaction with the care received (score /56)(Post-intervention: after the 8-week intervention (T2))
  • Range of motion (degrees, measured with a goniometer)(Pre-intervention: 1 to 3 weeks post fracture (T1) and Post-intervention: after the 8-week intervention (T2))
  • Cost of services from the perspective of the health system(Post-intervention: after the 8-week intervention (T2))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michel Tousignant

Professor

Université de Sherbrooke

研究点 (2)

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