UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021683 |
|---|---|
| Receipt number | R000025012 |
| Scientific Title | The study additionally performed in Hyogo Rehabilitation Center to evaluate the efficacy and safety in the Walkaide use attached to the funded PLEASURE study. |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2017/06/12 15:46:00 |
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Basic information
Public title
The study additionally performed in Hyogo Rehabilitation Center to evaluate the efficacy and safety in the Walkaide use attached to the funded PLEASURE study.
Acronym
The study additionally performed in Hyogo Rehabilitation Center in the PLEASURE study.
Scientific Title
The study additionally performed in Hyogo Rehabilitation Center to evaluate the efficacy and safety in the Walkaide use attached to the funded PLEASURE study.
Scientific Title:Acronym
The study additionally performed in Hyogo Rehabilitation Center in the PLEASURE study.
Region
| Japan |
Condition
Condition
Chronic stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy and safety for the human body with the Walkaide use.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood test after the PLEASURE study
Key secondary outcomes
ECG, bone density test, long-term outcome, gait analysis, pedometer measurement
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
All the cases who will be enrolled in the PLEASURE study at Hyogo Rehabilitation Center
Key exclusion criteria
None
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takaaki Chin |
Organization
Hyogo Rehabilitation Center
Division name
Robot Rehabilitation Center affiliated with Hyogo Rehabilitation Center, and Department of Physical Medicine and Rehabilitation
Zip code
Address
1070 Akebono-Cho, Nishi-ku, Kobe City, Hyogo, JAPAN
TEL
+81-78-927-2727
t_chin@hwc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mutsumi Fujii |
Organization
Hyogo Rehabilitation Center
Division name
Department of Physical Medicine and Rehabilitation
Zip code
Address
1070 Akebono-Cho, Nishi-ku, Kobe City, Hyogo, JAPAN
TEL
+81-78-927-2727
Homepage URL
m_fujii@hwc.or.jp
Sponsor or person
Institute
Hyogo Rehabilitation Center
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
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
兵庫県立リハビリテーション中央病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.congre.co.jp/jarm2017/summary/data/pdf/JARM2017_Program.pdf
Publication of results
Published
Result
URL related to results and publications
http://www.congre.co.jp/jarm2017/summary/data/pdf/JARM2017_Program.pdf
Number of participants that the trial has enrolled
Results
Gait analysis showed the ankle dorsiflextion in the swing phase increased. The coefficient of variation (CVRR) was analysed for all except one who showed atrial fibrillation. All patients showed the improvement of the low CVRR percentages. The result of muscle volume measurement from bone destiny test showed the increase volume in the normal side of the lower limb and the decrease volume in the parasis side of the lower limb in the both group. The ambulatory ability test showed the extended ability in the 6MD in the WA group and the ability continued until 6 month, meaning WA training may have carryover effect.
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
Main results already published
Date of protocol fixation
| 2016 | Year | 02 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 17 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 12 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 12 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 12 | Day |
Other
Other related information
All the candidates enrolled in the PLEASURE study from our institute will be performed pedometer measurement during walk training of PLEASURE study, gait analysis and some basic tests (blood test, ECG, and bone density test) before and after the 4-week-walk-training period of the PLEASURE study. Outcome study for the ambulatory ability will be evaluated on about 3 and 6 months after the walk training. Finally, this study is conducted concomitantly with PLEASURE study (UMIN000020458).
*Additional information on Oct 3rd, 2016: We have performed gait analysis for 6 cases, and we finished doing the analysis.
Management information
Registered date
| 2016 | Year | 03 | Month | 30 | Day |
Last modified on
| 2017 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025012
