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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04296123
• Other study ID #: WC-20200302002
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: March 31, 2024

Study information

• Verified date: February 2024
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 79
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

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.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Four Square Step Test		12 weeks
Primary	Four Square Step Test		24 weeks
Primary	Choice Stepping Reaction Time Test		12 weeks
Primary	Choice Stepping Reaction Time Test		24 weeks
Primary	Maximum Step Length Test		12 weeks
Primary	Maximum Step Length Test		24 weeks
Primary	Alternate Step Test		12 weeks
Primary	Alternate Step Test		24 weeks
Secondary	10-meter walk test		0, 12 and 24 weeks
Secondary	2-minute walk test		0, 12 and 24 weeks
Secondary	30-second sit to stand test		0, 12 and 24 weeks
Secondary	Berg balance scale	The score ranges from 0-56. A higher score indicates better balance control	0, 12 and 24 weeks
Secondary	Number of falls		0, 12 and 24 weeks
Secondary	Montreal Cognitive Assessment	The score ranges from 0-30. A higher score indicates better global cognitive function	0, 12 and 24 weeks