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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Main results already published |
Unique ID issued by UMIN | UMIN000021683 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Chronic stroke | |
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 | |
Institute | Hyogo Rehabilitation Center |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025012 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |