UMIN-CTR Clinical Trial

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

Contact us.