Skip to main content
Clinical Trials/NCT04296123
NCT04296123CompletedNot 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 enrollmentStarted: January 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
47
Locations
1
Primary Endpoint
Choice Stepping Reaction Time Test

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts 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

Arms & Interventions

Control

No Intervention

Intervention

Experimental

Intervention: Step training (Behavioral)

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Wayne Chan

Assistant Professor

The Hong Kong Polytechnic University

Study Sites (1)

Loading locations...

Similar Trials