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临床试验/NCT04296123
NCT04296123已完成不适用

Psychometric Properties of Four Step Tests and Effects of Step Training in Reducing Falls on Older Adults with Dementia

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2020年1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
已完成
入组人数
47
试验地点
1
主要终点
Choice Stepping Reaction Time Test

研究概览

简要总结

Abstract:

Objectives: (i) To investigate the test-retest and inter-rater reliability, construct and known-group validity of four independent step tests in older adults with mild to moderate dementia (Phase 1); and (ii) the feasibility and effects of a 12-week step training on the step performance, physical and functional outcomes in this population (Phase 2).

Design and subjects: Older adults who have mild to moderate dementia, and able to walk independently without walking aids, with stick or quadripod will be recruited to participate in this study. Participants will perform four step tests, including Four Square Step Test (FSST), Choice Stepping Reaction Time Test (CSRTT), Maximum Step Length Test (MSLT) and Alternate Step Test (AST) on three separate testing occasions conducted by two independent raters at the baseline (Phase 1).

The participants will then join either an intervention or control group. Those in the intervention group will receive a 12-week step training, while the control group will receive usual care. The stepping performance using the step tests validated in Phase 1, cognitive and functional outcomes and prospective falls will be compared between the intervention and control groups at 12 and 24 weeks (Phase 2).

Interventions: The step training consists of two 30-minute training sessions per week. The participants will receive an individualized, progressive training that is tailored to their stepping ability and cognitive function.

Main outcome measures: Stepping performance using the four step tests, 2-minute walk test, 10-meter walk test, 30-second sit to stand test, Berg Balance Scale, Montreal Cognitive Assessment and prospective falls at 12 and 24 weeks.

Expected results: (i) The four step tests are reliable in older adults with mild to moderate dementia, and the findings of the step tests are moderately associated with the functional outcomes, and (ii) the participants in the intervention group will have better stepping performance, better functional outcomes and fewer falls compared with the control group at 12 weeks, and the effects will sustain at 24 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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •65 years or above
  • •able to walk independently without walking aid, with stick or quadripod
  • •clinical diagnosis of dementia

排除标准

  • •unstable cardiac or pulmonary conditions
  • •acute musculoskeletal or severe neurological conditions affecting stepping performances
  • •severe hearing or visual impairment limiting communication
  • •severe cognitive impairment
  • •recent hospitalization in the past 30 days

研究组 & 干预措施

Intervention

Experimental

干预措施: Step training (Behavioral)

Control

No Intervention

结局指标

主要结局

Choice Stepping Reaction Time Test

时间窗: 24 weeks

Maximum Step Length Test

时间窗: 24 weeks

Alternate Step Test

时间窗: 24 weeks

Four Square Step Test

时间窗: 24 weeks

Four Square Step Test

时间窗: 12 weeks

Choice Stepping Reaction Time Test

时间窗: 12 weeks

Maximum Step Length Test

时间窗: 12 weeks

Alternate Step Test

时间窗: 12 weeks

次要结局

  • Number of falls(0, 12 and 24 weeks)
  • 10-meter walk test(0, 12 and 24 weeks)
  • 2-minute walk test(0, 12 and 24 weeks)
  • 30-second sit to stand test(0, 12 and 24 weeks)
  • Berg balance scale(0, 12 and 24 weeks)
  • Montreal Cognitive Assessment(0, 12 and 24 weeks)

研究者

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

Dr. Wayne Chan

Assistant Professor

The Hong Kong Polytechnic University

研究点 (1)

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