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临床试验/NCT04267354
NCT04267354已完成不适用

Arm Cycling in Facioscapulohumeral Dystrophy (FSHD) Patients

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust0 个研究点目标入组 15 人开始时间: 2016年12月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
主要终点
Oxford Shoulder Score

研究概览

简要总结

The investigators believe that arm cycling has the potential to be effective in maintaining or improving shoulder muscle functioning. However, there is no evidence for its safety or effectiveness in the upper extremity. The aim of the study is to establish the ability of FSHD sufferers to perform arm cycling to underpin the future design of an arm exercise trial. The study hypothesis is that the limited range of shoulder movement and muscle weakness should not impact the ability of FSHD sufferers to perform arm cycling.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Aged 18-60 years
  • •Genetically confirmed diagnosis of FSHD
  • •Willing to attend the assessment session
  • •Able to understand the participant information sheet and provide written informed consent

排除标准

  • •Aged <18 years or >60 years
  • •Co-morbidity that would affect their ability to perform arm cycling
  • •Unwilling to complete the assessments of the study
  • •Unable to understand the participant information sheet and provide written informed consent.

研究组 & 干预措施

Arm cycling

Experimental

Participants will perform arm cycling using a table-top arm cycler. Cadence and resistance of the exercise will be determined as per each individual's tolerance. All exercise will be supervised by the neuromuscular specialist physio, to ensure it is completed safely. Participants will be able to have plenty of breaks during the assessments.

干预措施: Arm cycling (Other)

结局指标

主要结局

Oxford Shoulder Score

时间窗: At one-off study visit: Prior to completion of exercise session

A 12 item patient-reported shoulder instability questionnaire. Each of the questions presents five possible responses corresponding to a score of 0 (most disability/pain) to 4 (least disability/pain). when the twelve items are summed, the questionnaire then produces a single score with a range from 0 (most disability/pain) to 48 (least disability/pain).

次要结局

  • Borg Rate of Perceived Exertion (RPE)(At one-off study visit: During exercise session)
  • Resistance of arm cycling(At one-off study visit: During exercise session)
  • Cadence of arm cycling(At one-off study visit: During exercise session)
  • Range of movement(At one-off study visit: Prior to completion of exercise session)
  • Strength of muscles at shoulder and elbow joints(At one-off study visit: Prior to completion of exercise session)
  • Video analysis(At one-off study visit: During exercise session)

研究者

发起方
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
申办方类型
Other Gov
责任方
Sponsor

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