UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049089 |
|---|---|
| Receipt number | R000055925 |
| Scientific Title | Effect of Gait Training Using Rhythmic Auditory Stimulation on Gait Speed in Older Adults Admitted to Convalescent Re-habilitation Wards: Pilot Randomized Controlled Clinical Trial |
| Date of disclosure of the study information | 2022/10/08 |
| Last modified on | 2024/03/08 18:30:40 |
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Basic information
Public title
Effect of Gait Training Using Rhythmic Auditory Stimulation on Gait Speed in Older Adults Admitted to Convalescent Re-habilitation Wards
Acronym
Effect of Gait Training Using Rhythmic Auditory Stimulation on Gait Speed in Older Adults Admitted to Convalescent Re-habilitation Wards
Scientific Title
Effect of Gait Training Using Rhythmic Auditory Stimulation on Gait Speed in Older Adults Admitted to Convalescent Re-habilitation Wards: Pilot Randomized Controlled Clinical Trial
Scientific Title:Acronym
Effect of Gait Training Using Rhythmic Auditory Stimulation on Gait Speed in Older Adults Admitted to Convalescent Re-habilitation Wards: Pilot Randomized Controlled Clinical Trial
Region
| Japan |
Condition
Condition
Older people who admitted the convalescent rehabilitation unit
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the preliminary efficacy of the RAS-based gait practice for older patients admitted to the convalescent rehabilitation wards.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the change in the 10-m walk test (10mWT) 3 weeks after the baseline assessment.
Key secondary outcomes
Secondary outcome is the change in the score of the Medical Outcome Study 8-Item Short-Form Health Survey (SF-8) and the Japanese version of the modified Gait Efficacy Scale (J-mGES) from baseline assessment to 3 weeks later.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Walking exercises are performed 30 min a day, 5 days a week for 3 weeks, in accordance with RAS using a metronome. The RAS tempo is equivalent to 110% of a comfortable walking speed.
Interventions/Control_2
For the control group, normal walking exercises are performed 30 min a day, 5 days a week for 3 weeks.
Interventions/Control_3
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Persons with sufficient cognitive ability to understand the content and purpose of the study
2)Can walk at least 10 m alone or with the assistance of a therapist
3)Persons who provide written consent before participation in this study.
Key exclusion criteria
1)Persons with significant hearing impairment such that they are unable to respond to verbal instructions or auditory stimuli
2)Persons with visual impairment that interferes with daily living.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Igusa |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8514
Address
3-39-22 Showa, Maebashi, Gunma
TEL
027-220-8952
h221c001@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Igusa |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8514
Address
3-39-22 Showa, Maebashi, Gunma
TEL
027-220-8952
Homepage URL
h221c001@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
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
Ethical Review Board for Medical Research Involving Human Subjects of Gunma University
Address
3-39-22 Showa, Maebashi, Gunma
Tel
027-220-8952
h221c001@gunma-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
| 2022 | Year | 10 | Month | 08 | 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
30
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 01 | Day |
Last modified on
| 2024 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055925
