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临床试验/NCT03904030
NCT03904030已完成不适用

Postoperative Rehabilitation After Knee Arthroplasty, With or Without Anti-Gravity Treadmill

Orton Orthopaedic Hospital2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
2
主要终点
Walking ability

研究概览

简要总结

The aim of this study is to clarify the effectiveness and the usefulness of the anti-gravity treadmill in postoperative rehabilitation after knee arthroplasty. The investigators will compare anti-gravity treadmill rehabilitation and the traditional postoperative rehabilitation with instructions.

The investigators will assume that anti-gravity treadmill exercise after hospitalization will lead to the faster rehabilitation, better walking quality and balance management compared to traditional rehabilitation methods with instructions, where patient themselves do the exercises at home. Additionally, the investigators will assume that quality of life and physical activity will be more increased in the anti-gravity group than in the traditional rehabilitation.

详细描述

The aim of this study is to clarify the effectiveness and the usefulness of the anti-gravity treadmill in postoperative rehabilitation after knee arthroplasty. This issue is especially relevant because the number of knee arthroplasty patients is increasing. The rehabilitation of knee arthroplasty patients has also appeared to be more challenging than in the case of hip arthroplasty.

The investigators will compare anti-gravity treadmill rehabilitation and the traditional postoperative rehabilitation with instructions. The investigators will recruit the patients either in the anti-gravity group (n=27) or in the traditional rehabilitation (n=27) (randomized study design).

The investigators will assume that anti-gravity treadmill exercise after hospitalization will lead to the faster rehabilitation, better walking quality and balance management compared to the traditional rehabilitation.

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 (Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • primary knee arthroplasty patients with grade III-V changes

排除标准

  • earlier osteotomy to the operated knee
  • rheumatoid arthritis

结局指标

主要结局

Walking ability

时间窗: 12 months after operation

6 minutes walking test will be used

Health-related quality of life

时间窗: 12 months

The RAND Health-Related Quality of Life Inventory, RAND 36-Item, will be used, RAND-36 includes: Physical functioning,10 questions; Role functioning/physical, 4 questions; Role functioning/emotional, 3 questions; Energy/fatique, 4 questions, Emotional well-being, 5 questions; Social functioning, 2 questions; Pain, 2 questions; General health, 5 questions; Health change, 1 question. All: 36 questions. Scale: 0 - 100

Perceived pain

时间窗: 12 months after operation

Visual analogue scale, (0 to 100, where 0 means no pain at all and 100 means the worst possible pain)

次要结局

未报告次要终点

研究者

发起方
Orton Orthopaedic Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leena Ristolainen

Research Director

Orton Orthopaedic Hospital

研究点 (2)

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