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Clinical Trials/NCT04296123
NCT04296123
Completed
Not Applicable

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

The Hong Kong Polytechnic University1 site in 1 country47 target enrollmentJanuary 1, 2020
ConditionsDementia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
The Hong Kong Polytechnic University
Enrollment
47
Locations
1
Primary Endpoint
Choice Stepping Reaction Time Test
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
March 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Wayne Chan

Assistant Professor

The Hong Kong Polytechnic University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Choice Stepping Reaction Time Test

Time Frame: 24 weeks

Maximum Step Length Test

Time Frame: 24 weeks

Alternate Step Test

Time Frame: 24 weeks

Four Square Step Test

Time Frame: 24 weeks

Secondary Outcomes

  • Number of falls(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)
  • 10-meter walk test(0, 12 and 24 weeks)
  • Berg balance scale(0, 12 and 24 weeks)
  • Montreal Cognitive Assessment(0, 12 and 24 weeks)

Study Sites (1)

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