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临床试验/NCT04625309
NCT04625309已完成不适用

Adaptive Sports for Individuals With a Physical Disability: Impact on the ICF Domains

Université Catholique de Louvain1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年10月7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
入组人数
34
试验地点
1
主要终点
Pain experienced during mobility

研究概览

简要总结

This study is a cross-sectional trial which aims to evaluate the effect of practicing a physical activity on different domains of the ICF among individuals with an acquired physical disability. Two different groups of individuals with a spinal cord injury will be enrolled: one composed of subjects who manage to reach the WHO's recommendations regarding physical activity, and the other of subjects who do not.

详细描述

The present study will recruit participants based on a set of defined eligibility criteria, in adaptive sports clubs teams and in groups or associations of individuals with an acquired, and permanent, physical disability. Based on the presence or absence of a regular physical activity practice undertaken by the subjects who give their consent to participate in the study, they will be divided into two groups: one where individuals regularly practice a physical activity, and one where they do not.

A set of defined outcome measures (detailed in the "Outcome Measures"section) will be assessed in both groups.

The outcomes measures will be analysed statistically, using SPSS software. Depending on the nature of the variables (qualitative or quantitative), different tests will be performed. Normality will also be verified and will determine which statistical analysis will be carried out.

研究设计

研究类型
Interventional
分配方式
Non 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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •diagnosed non-progressive spinal cord injury
  • •dependent on wheelchair for mobility
  • •more than 6 months since diagnosis of spinal injury
  • •able to understand and speak french

排除标准

  • •medical contra-indication to the testing
  • •cognitive deficiency which limits communication

研究组 & 干预措施

Sport

Experimental

This group will be made up of subjects with a spinal cord injury that are actively participating in adaptive sports teams.

干预措施: Adaptive sports (Other)

No sport

No Intervention

This group will be made up of subjects with a spinal cord injury that are not actively participating in any sports team.

结局指标

主要结局

Pain experienced during mobility

时间窗: Throughout the study, an average of 4 months

This variable will be measured through a Likert scale out of 5, where greater values show more pain during mobility. Subjects will be asked to rate presence, frequency and intensity of pain felt in the upper-limb when wheeling in their daily environments.

Fatigue Severity

时间窗: Throughout the study, an average of 4 months

This variable will be measured using a validated questionnaire, "Fatigue Severity scale". The minimum score is 9, and the maximum is 63. The higher the score, the greater the fatigue severity (= worse outcome for the participant).

Independence in mobility of daily living

时间窗: Throughout the study, an average of 4 months

This variable will be measured using the validated "Spinal Cord Independence Measure -mobility". Minimum score is 0 while maximum score is 40. The higher the score, the better the independence of the participant (=better outcome).

Physical activity level

时间窗: Through study completion, an average of 4 months

Measured by a validated questionnaire, "Physical Activity Scale for Individuals with a Physical Disability".

Social participation

时间窗: Throughout the study, an average of 4 months

This variable will be measured through the validated "Reintegration to Normal Living" index. Minimum score is 0, maximum score is 100. The higher the score, the better the outcome.

Quality of Life: WHOQOL-BREF

时间窗: Throughout the study, an average of 4 months

This variable will be measured through the World Health Organization's 8th version questionnaire, the WHOQOL-BREF. Every one of the 4 domain can obtain a score ranging from 0 (minimum) to 100 (maximum). The higher the score, the greater the quality of life.

patient's medical history

时间窗: Throughout the study, an average of 4 months

We will ask the subjects to report how many times they were hospitalised in the last six months and how many times they experienced a serious health-complication. We will also ask them how many times per week they receive physiotherapy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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