UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053379 |
|---|---|
| Receipt number | R000060852 |
| Scientific Title | Effects of a selective attention task practice in the sitting position on Anticipatory Postural Adjustment during stepping in older adults. |
| Date of disclosure of the study information | 2024/01/17 |
| Last modified on | 2025/02/04 14:59:45 |
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Basic information
Public title
Effects of a selective attention task practice in the sitting position on Anticipatory Postural Adjustment during stepping in older adults.
Acronym
Effects of a selective attention task practice in the sitting position on Anticipatory Postural Adjustment during stepping in older adults.
Scientific Title
Effects of a selective attention task practice in the sitting position on Anticipatory Postural Adjustment during stepping in older adults.
Scientific Title:Acronym
Effects of a selective attention task practice in the sitting position on Anticipatory Postural Adjustment during stepping in older adults.
Region
| Japan |
Condition
Condition
Healthy elderly
Healthy young adult
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of a selective attention task practice in the sitting position on Anticipatory Postural Adjustment during stepping in older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
APA error rate, reaction time, APA time, toe off time during stepping.
Key secondary outcomes
Stroop Color Word Test
10m gait speed
TUG (Timed up and go test)
FES (Fall Efficacy Scale)
Sitting task performance (reaction time, error)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Step task practice, 2 days a week, 3 weeks.
Interventions/Control_2
Desk task practice, 2 days a week, 3 weeks.
Interventions/Control_3
Control (non practice)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
･Community-dwelling elderly
･Healthy student
Key exclusion criteria
･Unable to safely and completely perform stepping due to a history of stroke, musculoskeletal disease, cardiovascular disease.
･Unable to understand instructions due to significant cognitive impairment (MMSE < 23).
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Uchiyama |
Organization
Nagoya University
Division name
Graduate School of Medicine
Zip code
461-8673
Address
1-1-20, Daiko-minami, Higashi-ku, Nagoya
TEL
052-719-3155
uchiyama@met.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Uchiyma |
Organization
Nagoya University
Division name
Graduate School of Medicine
Zip code
461-8673
Address
1-1-20, Daiko-minami, Higashi-ku, Nagoya
TEL
052-719-3155
Homepage URL
uchiyama@met.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Ethics Committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
052-741-2111
ethics@med.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
75
Results
In elderly adults, the APA error rate decreased significantly in both the step task practice group and the sitting task practice group.
Results date posted
| 2025 | Year | 02 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No significant differences were observed in participant characteristics among the three groups, both elderly and young.
Participant flow
Participants were assigned to three groups: the sitting task practice group, the stepping task practice group, and the control group. The assignment used stratified randomization based on
the APA error rates during the pre-test step task.
Adverse events
nothing
Outcome measures
main outcome:
APA error rate, reaction time, APA time, and toe-off time during stepping.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 17 | Day |
Last modified on
| 2025 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060852
