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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dementia
• Intervention / Treatment: Behavioral: Step training

• Study Type: Interventional
• Enrollment (Estimated): 79
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wayne Chan, PhD; Phone Number: 27666742; Email: wayne.ls.chan@polyu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Behavioral: Step 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.
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The score ranges from 0-56. A higher score indicates better balance control	0, 12 and 24 weeks
Number of falls		0, 12 and 24 weeks
Montreal Cognitive Assessment	The score ranges from 0-30. A higher score indicates better global cognitive function	0, 12 and 24 weeks

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Wayne Chan, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 5, 2020

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: WC-20200302002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No