UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041888 |
|---|---|
| Receipt number | R000047806 |
| Scientific Title | Predictors of falls in patients with amyotrophic lateral sclerosis: A multicenter observational study |
| Date of disclosure of the study information | 2020/09/24 |
| Last modified on | 2024/03/28 13:04:07 |
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Basic information
Public title
Predictors of falls in patients with amyotrophic lateral sclerosis: A multicenter observational study
Acronym
Predictors of falls in patients with amyotrophic lateral sclerosis
Scientific Title
Predictors of falls in patients with amyotrophic lateral sclerosis: A multicenter observational study
Scientific Title:Acronym
Predictors of falls in patients with amyotrophic lateral sclerosis
Region
| Japan |
Condition
Condition
Amyotrophic lateral sclerosis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory investigation of predictive indexes based on simple and clinically used functional assessments to identify the presence or absence of falls in ALS patients at 3 months after assessment.
Basic objectives2
Others
Basic objectives -Others
Identifying the actual status of falls in ALS patients
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Occurrence of a fall after 3 months
Key secondary outcomes
Frequency of falls after 3 months
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with a diagnosis of amyotrophic lateral sclerosis (diagnosed as Definite or Probable by the revised EL Escorial or Awaji criteria)
2) Patients with a prescription for physical therapy while attending or hospitalized at a research center
3) A person who can walk independently (use of orthosis or walking aids is acceptable)
Key exclusion criteria
1) A person who has not been notified of the diagnosis by his or her doctor
2) Individuals with comorbidities that would make evaluation or investigation in this study difficult or have a significant effect
3) Any other person who is deemed inappropriate by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koshiro |
| Middle name | |
| Last name | Haruyama |
Organization
Juntendo University
Division name
Department of Physical Therapy, Faculty of Health Science
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
k.haruyama.us@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Koshiro |
| Middle name | |
| Last name | Haruyama |
Organization
Juntendo University
Division name
Department of Physical Therapy, Faculty of Health Science
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
k.haruyama.us@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center Hospital of Neurology and Psychiatry
Brain Attack Center Ota Memorial Hospital
National Hospital Organization Higashisaitama National Hospital
Saitama Neuropsychiatric Institute
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University, Faculty of Health Science
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-3813-3111
k.haruyama.us@juntendo.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
| 2020 | Year | 09 | Month | 24 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
As a screening tool for predicting falls, the following data will be obtained:
1) age, gender, site of onset, disease duration, walking aids, medication
2) ALS Functional Rating Scale-revised, fall history, fear of falling, drop-foot, dropped neck
3) Manual Muscle Testing, Range of motion, Modified Ashworth Scale, Timed Up and Go test, 4 static balance test, 4m gait speed, sit-to-stand test.
Management information
Registered date
| 2020 | Year | 09 | Month | 24 | Day |
Last modified on
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047806
