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临床试验/NCT03196674
NCT03196674Unknown不适用

The Effect of Controlled Feedback on the Rehabilitation of Individuals With Disability Due to Stiff Shoulder Following Trauma

Isabella Shvartz2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Shoulder range of motion

研究概览

简要总结

This study will compare the effect of manipulated vs. non-manipulated feedback during the rehabilitation of individuals with disability due to stiff shoulder following multiple trauma. This will be accomplished using the state-of-the-art real-time motion capture technology.

详细描述

In this intervention, comparative study, 30 individuals with stiff shoulder following fracture to the proximal humerus (4 weeks to 6 months following the injury) will be treated at the Gait and Motion Laboratory at the Hadassah Medical Center in Jerusalem. Each subject will undergo a 12-session treatment (2-3 times a week, 30 minutes per session). In each session, reflective markers will be placed on the upper or lower body of the patient. Ten fast infra-red cameras will detect the movement of the patient and provide real-time feedback when obtaining a correct movement pattern, as instructed by the therapist, pretrial. The motion capture system will provide visual and auditory feedback of success, via a large screen, located on the wall. This could be manipulated so that the feedback is provided for a slightly higher range than instructed by the therapist.

The subjects will be randomly divided into two groups. One group will receive the non-manipulated feedback treatment for 6 sessions and then the manipulated feedback treatment for the remaining 6 sessions and vice versa for the second group. The shoulder passive and active range of motions, pain and activity levels will be tested 3 times: at baseline, following 6 and 12 sessions. A satisfactory questionnaire will be filled out by each patient twice, following 6 and 12 sessions.

The study will test for no differences in the overall progress of the patients during the 12-session rehabilitation period. The study will further test for differences in all outcome measures between the manipulated and non-manipulated treatment sessions.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Restricted shoulder motion (up to 90 degrees in abduction and flexion) following proximal humerus fracture, 4 weeks to 6 months following injury, without rotatory cuff tear
  • Normal or corrected eyesight and hearing.

排除标准

  • Neurological deficiencies that restrict upper limb.
  • Previous injury to the shoulder

研究组 & 干预措施

non-manipulated feedback

Active Comparator

干预措施: Biofeedback via motion capture (Other)

manipulated feedback

Active Comparator

干预措施: Biofeedback via motion capture (Other)

结局指标

主要结局

Shoulder range of motion

时间窗: 12 weeks

次要结局

  • Pain level(12 weeks)
  • The Disabilities of the Arm, Shoulder and Hand questionnaire(12 weeks)

研究者

发起方
Isabella Shvartz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Isabella Shvartz

MD

Hadassah Medical Organization

研究点 (2)

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