UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000824 |
|---|---|
| Receipt number | R000000986 |
| Scientific Title | Trial for Cerebellar Ataxia Rehabilitation |
| Date of disclosure of the study information | 2007/09/12 |
| Last modified on | 2011/09/12 09:34:39 |
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Basic information
Public title
Trial for Cerebellar Ataxia Rehabilitation
Acronym
CAR trial
Scientific Title
Trial for Cerebellar Ataxia Rehabilitation
Scientific Title:Acronym
CAR trial
Region
| Japan |
Condition
Condition
Spinocerebellar degeneration
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test if intensive rehabilitation improve ataxia and its related disability in patients with cerebellar ataxia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
SARA (Scale for the assessment and rating of Ataxia
FIM (Functional Independence Measure)
Key secondary outcomes
Gait speed
Cadence
Functional Ambulation Category (FAC)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Physical therapy and Occupational therapy followed by Observation
Interventions/Control_2
Observation followed by Physical therapy and Occupational therapy
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
Patients with spinocerebellar degeneration with isolated cerebellar symptoms (SCA6,16qADC or LCCA)
No cognitive impairment (MMSE>=24)
Ambulatory or ambulatory with assistance of one person
Key exclusion criteria
Prior stroke, pain with arthritis during gait, dyspnea or chest pain induced by a low intensity exercise, poor endurance due to cardiopulmonary diseases
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatoyo Nishizawa |
Organization
Brain Research Institute, Niigata University
Division name
Department of Neurology
Zip code
Address
1-757, Asahi-machi-dori, Niigata, Niigata, Japan 951-8585
TEL
025-227-0663
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mizuki Ito |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Neurology
Zip code
Address
65 Tsuruma-Cho, Showa-Ku,Nagoya, 466-8550, Japan
TEL
052-744-2391
Homepage URL
itohm@med.nagoya-u.ac.jp
Sponsor or person
Institute
Brain Research Institute, Niigata University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for "the Research Committee for Ataxic Diseases" of the Research on Measures for Intractable Diseases
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2007 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Short-term benefit of intensive rehabilitation was evident in patients with degenerative cerebellar diseases. Although the functional status tended to decline to the baseline level within 24 weeks, saving of the functional gains was seen in more than half of the patients at 24 weeks after the intervention.
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
| 2007 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 06 | Month | 01 | Day |
Other
Other related information
Miyai I, Ito M, Hattori N, Mihara M, Hatakenaka M, Yagura H, Sobue G, Nishizawa M. Cerebellar Ataxia Rehabilitation (CAR) trial in degenerative cerebellar diseases. Neurorehabilitation and Neural Repair 2011, in press.
Management information
Registered date
| 2007 | Year | 09 | Month | 12 | Day |
Last modified on
| 2011 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000986
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
