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Completed

NCT Number: NCT04296123

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Step training

Behavioral

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.

Primary outcomes

  1. Four Square Step Test

    Time frame: 12 weeks

  2. Four Square Step Test

    Time frame: 24 weeks

  3. Choice Stepping Reaction Time Test

    Time frame: 12 weeks

  4. Choice Stepping Reaction Time Test

    Time frame: 24 weeks

  5. Maximum Step Length Test

    Time frame: 12 weeks

  6. Maximum Step Length Test

    Time frame: 24 weeks

  7. Alternate Step Test

    Time frame: 12 weeks

  8. Alternate Step Test

    Time frame: 24 weeks

Secondary outcomes

  1. 10-meter walk test

    Time frame: 0, 12 and 24 weeks

  2. 2-minute walk test

    Time frame: 0, 12 and 24 weeks

  3. 30-second sit to stand test

    Time frame: 0, 12 and 24 weeks

  4. Berg balance scale

    Time frame: 0, 12 and 24 weeks

    The score ranges from 0-56. A higher score indicates better balance control

  5. Number of falls

    Time frame: 0, 12 and 24 weeks

  6. Montreal Cognitive Assessment

    Time frame: 0, 12 and 24 weeks

    The score ranges from 0-30. A higher score indicates better global cognitive function

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 5, 2020
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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