UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044782 |
|---|---|
| Receipt number | R000051147 |
| Scientific Title | Randomized trial to verify the effect of unified procedure rehabilitation for postural abnormalities in Parkinson's disease and related disorders |
| Date of disclosure of the study information | 2021/07/07 |
| Last modified on | 2021/07/07 12:37:59 |
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Basic information
Public title
Randomized trial to verify the effect of unified procedure rehabilitation for postural abnormalities in Parkinson's disease and related disorders
Acronym
Randomized trial to verify the effect of unified procedure rehabilitation for postural abnormalities in Parkinson's disease and related disorders
Scientific Title
Randomized trial to verify the effect of unified procedure rehabilitation for postural abnormalities in Parkinson's disease and related disorders
Scientific Title:Acronym
Randomized trial to verify the effect of unified procedure rehabilitation for postural abnormalities in Parkinson's disease and related disorders
Region
| Japan |
Condition
Condition
Parkinson's disease and related disorders
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effectiveness of a rehabilitation program that combines vibration stimulation and posture learning with a general rehabilitation program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of posture (flexion angle) after implementation of rehabilitation program
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The posture disorder treatment program developed at our hospital is called the Multidisciplinary Approach for Postural and Gait Disorder(MADI).
A. MADI rehabilitation procedure
(1) Lower the muscle tonus of the whole body with a handy massager (to relax the excess force of the whole body and make it easier to change the posture) (2) After lowering the muscle tonus, correct the posture recognition by the feedback in the words of the therapist. (3) If the posture deteriorates due to standing or walking (including walking on the treadmill), point out in words or manually correct the posture. The procedure of (1)(2)(3) shall be 80% or more of the rehabilitation implementation time. The above rehabilitation will be carried out for 3 weeks.
Interventions/Control_2
B. Traditional rehabilitation procedure
The content of rehabilitation is left to the therapist in charge. Do not use a handy massager. Rehabilitation will be conducted 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
| 10 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Parkinson's disease and related disorders; People have a clinical diagnosis of Parkinson's disease, multiple system atrophy, or progressive supranuclear palsy
2) Postural abnormalities including camptocormia, Pisa syndrome, and drop head syndrome interfere with activities of daily living
3) Standing and walking are possible without assistance
4) Those who receive the information of this study, and express their willingness to participate in it.
Key exclusion criteria
1) Those who cannot maintain a standing position
2) Severe gait disorders; GAIT score of MDS-UPDRS is 3 or higher, and/or FREEZING OF GAIT score is 2 or higher
3) Dementia that interferes with daily life
4) Severe spinal abnormalities such as spondylolisthesis or compression fractures
5) Posture correction causes or exacerbates low back pain or neck pain
6) Severe muscle atrophy confirmed by CT
7) Muscle disease suspected by muscle MRI
8) Those who the principal investigator deems inappropriate
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Mukai |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of neurology
Zip code
187-8551
Address
Ogawahigashicho, Kodaira, Tokyo, 187-8551, Japan
TEL
+81-42-341-2711
ymukai@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Mukai |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of neurology
Zip code
187-8551
Address
Ogawahigashicho, Kodaira, Tokyo, 187-8551, Japan
TEL
+81-42-341-2711
Homepage URL
ymukai@ncnp.go.jp
Sponsor or person
Institute
National Research and Development Agency
Institute
Department
Personal name
Funding Source
Organization
National Research and Development Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of NCNP
Address
Ogawahigashicho, Kodaira, Tokyo, 187-8551, Japan
Tel
+81-42-341-2712
rinri-jimu@ncnp.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 07 | 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 | 07 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 07 | 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
Management information
Registered date
| 2021 | Year | 07 | Month | 07 | Day |
Last modified on
| 2021 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051147
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| Registered date | File name |
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