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

• Sponsor: The Hong Kong Polytechnic University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04296123
• Collaborator: (none)
• Enrollment: 79
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 41.9
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia	Behavioral: Step training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Psychometric Properties of Four Step Tests and Effects of Step Training in Reducing Falls on Older Adults With Dementia
• Actual Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Four Square Step Test [12 weeks]

2. Four Square Step Test [24 weeks]

3. Choice Stepping Reaction Time Test [12 weeks]

4. Choice Stepping Reaction Time Test [24 weeks]

5. Maximum Step Length Test [12 weeks]

6. Maximum Step Length Test [24 weeks]

7. Alternate Step Test [12 weeks]

8. Alternate Step Test [24 weeks]

Secondary Outcome Measures

1. 10-meter walk test [0, 12 and 24 weeks]

2. 2-minute walk test [0, 12 and 24 weeks]

3. 30-second sit to stand test [0, 12 and 24 weeks]

4. Berg balance scale [0, 12 and 24 weeks]

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

5. Number of falls [0, 12 and 24 weeks]

6. Montreal Cognitive Assessment [0, 12 and 24 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Hong Kong Polytechnic University	Hong Kong		Hong Kong

Sponsors and Collaborators

• The Hong Kong Polytechnic University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Wayne Chan, Assistant Professor, The Hong Kong Polytechnic University
• ClinicalTrials.gov Identifier: NCT04296123
• Other Study ID Numbers: WC-20200302002
• First Posted: Mar 5, 2020
• Last Update Posted: Mar 16, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dementia

Study Results

No Results Posted as of Mar 16, 2022