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临床试验/NCT07195526
NCT07195526已完成不适用

Getting Seniors Back on Their Bicycle; a Pretest-posttest Case-control Study on the Improvement of Bicycle Balance Control

Donders Centre for Cognitive Neuroimaging1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2023年3月31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
23
试验地点
1
主要终点
Bicycle balance control skill and confidence

研究概览

简要总结

This study investigates the effectiveness of an intervention that aims at restoring bicycle balance control skills in seniors that have quit cycling. The intervention will last 11 weeks and involves three components: (1) training on an exercise bicycle, (2) a balance control training on a bicycle simulator, and (3) cycling on the public roads with a safe start-and-stop technique that was practiced on the bicycle simulator. In the bicycle simulator training, the difficulty of the balance control will be increased gradually, slowly approaching the difficulty of bicycle balance control on the public roads.

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

性别
All
接受健康志愿者
否

入选标准

  • •Persons that stopped cycling at least six months ago and want to get back on their bicycle.

排除标准

  • •Balance-relevant sensory disorders (peripheral neuropathy, labyrinthitis, vestibular neuritis, …)

研究组 & 干预措施

Bicycle balance control training

Experimental

The intervention involveds three components: (1) training on an exercise bicycle, (2) a balance control training on a bicycle simulator, and (3) cycling on the public roads with a safe start-and-stop technique that will be practiced on the bicycle simulator. In the bicycle simulator training, the difficulty of the balance control was increased gradually, slowly approaching the difficulty of bicycle balance control on the public roads.

干预措施: Bicycle balance control training (Behavioral)

Control group

No Intervention

The participants in the experimental group are matched to the participants in the control group. The control group participants are selected based on their distance from the location of the intervention; control group participants live farther away from the location of the intervention as compared to the experimental group.

结局指标

主要结局

Bicycle balance control skill and confidence

时间窗: Pretest: Between the second and the third week of June 2023 Posttest: First week of October 2023

This outcome variable will be obtained from a questionnaire that evaluates participants' bicycle BC skills and confidence while riding on the public roads. For each of three environments (without traffic, little traffic, busy traffic), participants must indicate what applies to them: (1) "I did not ride my bicycle here", (2) "I rode my bicycle here, but I try to avoid it", and (3) "I rode my bicycle here without problems". The answers to every question/environment were converted into a score by assigning 0, 1, and 2 points to the respective options. Summing these scores over the three questions/environments results in a number between 0 and 6, which is the outcome variable.

次要结局

  • One-minute functional threshold power (1minFTP)(From the third week of June 2023 until the second week of August 2023)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eric Maris

Principal Investigator

Donders Centre for Cognitive Neuroimaging

研究点 (1)

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