Clinical trial NCT04296123: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 47
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Four Square Step Test
timeFrame: 12 weeks
measure: Four Square Step Test
timeFrame: 24 weeks
measure: Choice Stepping Reaction Time Test
timeFrame: 12 weeks
measure: Choice Stepping Reaction Time Test
timeFrame: 24 weeks
measure: Maximum Step Length Test
timeFrame: 12 weeks
measure: Maximum Step Length Test
timeFrame: 24 weeks
measure: Alternate Step Test
timeFrame: 12 weeks
measure: Alternate Step Test
timeFrame: 24 weeks
Secondary outcomes:
measure: 10-meter walk test
timeFrame: 0, 12 and 24 weeks
measure: 2-minute walk test
timeFrame: 0, 12 and 24 weeks
measure: 30-second sit to stand test
timeFrame: 0, 12 and 24 weeks
measure: Berg balance scale
timeFrame: 0, 12 and 24 weeks
measure: Number of falls
timeFrame: 0, 12 and 24 weeks
measure: Montreal Cognitive Assessment
timeFrame: 0, 12 and 24 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Wayne Chan, PhD
role: PRINCIPAL_INVESTIGATOR
References: