Psychometric Properties of Four Step Tests and Effects of Step Training in Reducing Falls on Older Adults With Dementia
Primary Purpose
Dementia
Status
Active
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Step training
Sponsored by
About this trial
This is an interventional treatment trial for Dementia
Eligibility Criteria
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
Sites / Locations
- The Hong Kong Polytechnic University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Outcomes
Primary Outcome Measures
Four Square Step Test
Four Square Step Test
Choice Stepping Reaction Time Test
Choice Stepping Reaction Time Test
Maximum Step Length Test
Maximum Step Length Test
Alternate Step Test
Alternate Step Test
Secondary Outcome Measures
10-meter walk test
2-minute walk test
30-second sit to stand test
Berg balance scale
The score ranges from 0-56. A higher score indicates better balance control
Number of falls
Montreal Cognitive Assessment
The score ranges from 0-30. A higher score indicates better global cognitive function
Full Information
NCT ID
NCT04296123
First Posted
March 2, 2020
Last Updated
September 20, 2023
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT04296123
Brief Title
Psychometric Properties of Four Step Tests and Effects of Step Training in Reducing Falls on Older Adults With Dementia
Official Title
Psychometric Properties of Four Step Tests and Effects of Step Training in Reducing Falls on Older Adults With Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
79 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Step training
Intervention Description
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 Outcome Measure Information:
Title
Four Square Step Test
Time Frame
12 weeks
Title
Four Square Step Test
Time Frame
24 weeks
Title
Choice Stepping Reaction Time Test
Time Frame
12 weeks
Title
Choice Stepping Reaction Time Test
Time Frame
24 weeks
Title
Maximum Step Length Test
Time Frame
12 weeks
Title
Maximum Step Length Test
Time Frame
24 weeks
Title
Alternate Step Test
Time Frame
12 weeks
Title
Alternate Step Test
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
10-meter walk test
Time Frame
0, 12 and 24 weeks
Title
2-minute walk test
Time Frame
0, 12 and 24 weeks
Title
30-second sit to stand test
Time Frame
0, 12 and 24 weeks
Title
Berg balance scale
Description
The score ranges from 0-56. A higher score indicates better balance control
Time Frame
0, 12 and 24 weeks
Title
Number of falls
Time Frame
0, 12 and 24 weeks
Title
Montreal Cognitive Assessment
Description
The score ranges from 0-30. A higher score indicates better global cognitive function
Time Frame
0, 12 and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne Chan, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Psychometric Properties of Four Step Tests and Effects of Step Training in Reducing Falls on Older Adults With Dementia
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