UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039024 |
|---|---|
| Receipt number | R000044501 |
| Scientific Title | The effect of body weight supported overground training for patients with Parkinson's disease: case control trial |
| Date of disclosure of the study information | 2020/01/06 |
| Last modified on | 2019/12/27 19:20:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of body weight supported overground training
Acronym
The effect of BWSOT
Scientific Title
The effect of body weight supported overground training for patients with Parkinson's disease: case control trial
Scientific Title:Acronym
The effect of BWSOT for patients with Parkinson's disease: case control trial
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of partially unloading walking exercise using a mobile hoist on motor function and disease severity for Parkinson's disease patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Patients without medication adjustment were measured before and 4 weeks after the intervention.
Unified Prkinson's Disease Rating Scale,10m Walk Test,Timed Up & Go Test,6minuts walking Distance,Berg Balance Scale
Key secondary outcomes
Velocity,Stride length,Cadence,TUG Steps
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hoehn and Yahr2-4
No medicationadjustment or more than 1 week after adjustment.
Patients who can accurately measure all evaluation items.
Key exclusion criteria
Patients with cerebrovascular disease or sequelae of cerebrovascular disease.
No complications affecting motor function.
Items for which evaluation items cannot be measured.
Patients who disagree with the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hareaki |
| Middle name | |
| Last name | Seki |
Organization
Department of National Hospital Organization,Iwaki Hospital
Division name
Department of Neurology
Zip code
971-8126
Address
88-1 Yago, Ona Hamanoda, Iwaki City, Fukushima Prefecture
TEL
0246-88-7101
seki.hareaki.er@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Yasuki |
| Middle name | |
| Last name | Koyanagi |
Organization
Department of National Hospital Organization,Iwaki Hospital.
Division name
Department of Rehabilitation
Zip code
971-8126
Address
88-1 Yago, Ona Hamanoda, Iwaki City, Fukushima Prefecture.
TEL
0246-88-7101
Homepage URL
yasking9@gmail.com
Sponsor or person
Institute
Department of National Hospital Organization,Iwaki Hospital.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Iwaki Hospital Ethics Review Committee
Address
88-1 Yago, Ona Hamanoda, Iwaki City, Fukushima Prefecture.
Tel
0246-88-7101
koyanagi.yasuki.sf@mail.hosp.go.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
独立行政法人国立病院機構いわき病院（福島県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 06 | 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
40
Results
Unified Prkinson's Disease Rating Scale,10m Walk Test,Timed Up & Go Test,6minuts walking Distance.
Results date posted
| 2019 | Year | 12 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Parkinson's disease patient admitted to Iwaki Hospital
Participant flow
Intervene after rehabilitation prescription and conduct test measurement. Re-evaluation after 4 weeks of BWSOT or regular rehabilitation.
Adverse events
None
Outcome measures
Unified Prkinson's Disease Rating Scale,10m Walk Test,Timed Up & Go Test,6minuts walking Distance.
Plan to share IPD
None
IPD sharing Plan description
Management within the Iwaki Hospital network system
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
A retrospective study of the effects of regular rehabilitation and BWSOT.
Management information
Registered date
| 2019 | Year | 12 | Month | 27 | Day |
Last modified on
| 2019 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044501
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
