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临床试验/NCT02589184
NCT02589184撤回不适用

Effects on Shoulder Pain of Simulated Hyper-gravity During Rehabilitation Exercises

Carrick Institute for Graduate Studies2 个研究点 分布在 1 个国家开始时间: 2015年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Changes in pain level

研究概览

简要总结

Determine if adding "extra-gravity" (sustained increase in vertical loading) during standard rehabilitation exercises has a beneficial effect on pain reduction in subjects suffering from shoulder pain of different origin.

详细描述

Standard rehabilitation protocols will be used with every subject, depending on the cause of their shoulder pain. The treating clinician will determine the appropriate therapy protocol for each subject.

During the treatment sessions, subjects will wear a very comfortable waist belt attached with rubber band to anchor points on the ground (the rubber bands will be tighten to simulate the extra-gravity).

Upon enrollment, the treating clinician will randomly assign the subject to one of four groups depending on the type of loading and exercise typology.

The hyper-gravity will be simulated as an additional 50% of subject's body weight.

The frequency and duration of each therapy session will be determined by the treating clinician (usually 45 minutes of therapy twice a week for 4 weeks).

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
None

入排标准

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

入选标准

  • •Diagnosis of shoulder pain (potentially including rotator cuff pathology, impingement, bursitis, SLAP tear)

排除标准

  • •adhesive capsulitis, fracture, dislocation, inflammatory arthritis, cancer, ligament disruption

研究组 & 干预措施

hypergravity WITHOUT isometric load

Experimental

Patient performing rehabilitation exercises under hypergravity

干预措施: Hypergravity (Other)

hypergravity WITH isometric load

Experimental

Patient performing rehabilitation exercises under hypergravity as well as loaded isometric squats

干预措施: Hypergravity (Other)

hypergravity WITH isometric load

Experimental

Patient performing rehabilitation exercises under hypergravity as well as loaded isometric squats

干预措施: isometric load (Other)

normal gravity WITH isometric load

Experimental

Patient performing rehabilitation exercises under normal gravity as well as loaded isometric squats

干预措施: isometric load (Other)

normal gravity WITH isometric load

Experimental

Patient performing rehabilitation exercises under normal gravity as well as loaded isometric squats

干预措施: normal gravity (Other)

normal gravity WITHOUT isometric load

Active Comparator

Patient performing rehabilitation exercises under normal gravity

干预措施: normal gravity (Other)

结局指标

主要结局

Changes in pain level

时间窗: three months

The patient will grade the pain level using a numeric pain scale (0 no pain; 10 unbearable pain requiring pain medication). Changes will be assessed between baseline (before therapy sessions) and three month post therapy. It will be used to investigate if there is any statistical difference between the different therapies.

次要结局

  • Changes in Stability Score(three months)
  • Changes in shoulder range of motion(three months)
  • Changes in Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure(three months)
  • Test of Sustained Selective Attention (TOSSA)(three months)

研究者

发起方
Carrick Institute for Graduate Studies
申办方类型
Other
责任方
Principal Investigator
主要研究者

Frederick Carrick, PhD, FACCN

Principal investigator

Carrick Institute for Graduate Studies

研究点 (2)

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