UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022315 |
|---|---|
| Receipt number | R000025618 |
| Scientific Title | Effect of curved gait training in patients with stroke |
| Date of disclosure of the study information | 2016/05/16 |
| Last modified on | 2017/05/16 09:47:57 |
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Basic information
Public title
Effect of curved gait training in patients with stroke
Acronym
Effect of curved gait training
Scientific Title
Effect of curved gait training in patients with stroke
Scientific Title:Acronym
Effect of curved gait training
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantify the effect of curved gait training in subjects with stroke
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Step length after 8 weeks training
Key secondary outcomes
Gait symmetry, step time, and gait speed before and after 8 weeks training
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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Curved gait training, Rest period: 8 weeks, and Gait training in straight line
Curved gait training: three times a week for 8 weeks
(1) 20 minutes of curved gait training
(2) stretching
(3) muscle strength training
(4) balance training
Gait training in straight line: three times a week for 8 weeks
(1) 20 minutes of gait training in straight line
(2) stretching
(3) muscle strength training
(4) balance training
Interventions/Control_2
Gait training in straight line, Rest period: 8 weeks, and Curved gait training
Gait training in straight line: three times a week for 8 weeks
(1) 20 minutes of gait training in straight line
(2) stretching
(3) muscle strength training
(4) balance training
Curved gait training: three times a week for 8 weeks
(1) 20 minutes of curved gait training
(2) stretching
(3) muscle strength training
(4) balance training
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) hemiparesis resulting from a unilateral cortical or sub-cortical brain lesion
(2) >6 months since onset
(3) able to walk more than 10 m
Key exclusion criteria
(1) inability to provide informed consent
(2) a history of other neurologic, respiratory, cardiovascular, or orthopedic problems that would influence their participation in this study
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaoru Sakuma |
Organization
Kansai University of Welfare Sciences
Division name
Department of Rehabilitation Sciences
Zip code
Address
3-11-1, asahigaoka, kashiwara, Osaka 582-0026 Japan
TEL
072-947-5686
ksakuma@tamateyama.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaoru Sakuma |
Organization
Kansai University of Welfare Sciences
Division name
Department of Rehabilitation Sciences
Zip code
Address
3-11-1, asahigaoka, kashiwara, Osaka 582-0026 Japan
TEL
072-947-5686
Homepage URL
ksakuma@tamateyama.ac.jp
Sponsor or person
Institute
Kansai University of Welfare Sciences
Institute
Department
Personal name
Funding Source
Organization
Grants-in-aid for Scientific Research
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
| 2016 | Year | 05 | Month | 16 | 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
Suspended
Date of protocol fixation
| 2016 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 15 | Day |
Last modified on
| 2017 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025618
