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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04296123
Enrollment
47
Registered
2020-03-05
Start date
2020-01-01
Completion date
2024-03-31
Last updated
2024-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Brief 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.

Interventions

BEHAVIORALStep training

A 12-week step training consisting of two 30-minute training session per week. The participants will be instructed to stand upright and step on different targets on a plastic mat repeatedly.

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Four Square Step Test12 weeks
Choice Stepping Reaction Time Test12 weeks
Maximum Step Length Test12 weeks
Alternate Step Test12 weeks

Secondary

MeasureTime frameDescription
Number of falls0, 12 and 24 weeks
10-meter walk test0, 12 and 24 weeks
Montreal Cognitive Assessment0, 12 and 24 weeksThe score ranges from 0-30. A higher score indicates better global cognitive function
2-minute walk test0, 12 and 24 weeks
30-second sit to stand test0, 12 and 24 weeks
Berg balance scale0, 12 and 24 weeksThe score ranges from 0-56. A higher score indicates better balance control

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026