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

NCT04296123 | Completed

• 1 other identifier: WC-20200302002
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Outcome Measures

Primary Outcomes (8)

• Four Square Step Test

  12 weeks

• Four Square Step Test

  24 weeks

• Choice Stepping Reaction Time Test

  12 weeks

• Choice Stepping Reaction Time Test

  24 weeks

• Maximum Step Length Test

  12 weeks

• Maximum Step Length Test

  24 weeks

• Alternate Step Test

  12 weeks

• Alternate Step Test

  24 weeks

Secondary Outcomes (6)

• 10-meter walk test

  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

• Berg balance scale

  0, 12 and 24 weeks

• Number of falls

  0, 12 and 24 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Step training

Control

NO INTERVENTION

Interventions

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.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (1)

• Chan WLS, Tsang SMH, Ho LYW. Reliability and Validity of Four Step Tests in Older Adults With Dementia. Int J Geriatr Psychiatry. 2024 Dec;39(12):e70021. doi: 10.1002/gps.70021.

  PMID: 39608824 DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Wayne Chan, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 5, 2020
• Study Start: January 1, 2020
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: October 4, 2024

Record last verified: 2024-10

Locations

HK (1)