Psychometric Properties of Four Step Tests & Effects of Step Training in

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Dementia

Clinical Trial Details

NCT number	NCT04296123
Study type	Interventional
Source	The Hong Kong Polytechnic University
Contact
Status	Active, not recruiting
Phase	N/A
Start date	January 1, 2020
Completion date	March 31, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms