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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

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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
Email 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
Email 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
Email

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
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

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