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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028576
Receipt No. R000032624
Scientific Title Effects of a hip extension movement assist on the gait of stroke using a walking assist device ACSIVE
Date of disclosure of the study information 2017/09/01
Last modified on 2019/08/13

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Basic information
Public title Effects of a hip extension movement assist on the gait of stroke using a walking assist device ACSIVE
Acronym Effects of a hip extension movement assist on the gait of stroke
Scientific Title Effects of a hip extension movement assist on the gait of stroke using a walking assist device ACSIVE
Scientific Title:Acronym Effects of a hip extension movement assist on the gait of stroke
Region
Japan

Condition
Condition Cerebrovascular disease
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To analyze the influence on hip flexion moment by implementing the hip joint extension movement assist on the affected side in stance phase to stroke patients with ACSIVE walking support equipment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Hip joint moment with or without ACSIVE during gait.
Key secondary outcomes Hip joint angle with or without ACSIVE during gait.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Put the marker on the shoulder, pelvis, and joint of the lower limbs on both side and walk with the walking course with the floor reaction force gauge with comfortable walking speed with or without ACSIVE. Measure the state of walking simultaneously with four video cameras. The required time is about 45 minutes.
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Users of Nagoya city Rehabilitation center with ability to walk independently in indoors.
Key exclusion criteria Those who can not understand the explanation of the research by reason of severe cognitive impairment.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Masaki
Middle name
Last name Ishiguro
Organization Nagoya City Rehabilitation Agency
Division name Division of Physical Therapy
Zip code 4678622
Address 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL 052-835-3811
Email Physical@nagoya-rehab.or.jp

Public contact
Name of contact person
1st name Masaki
Middle name
Last name Ishiguro
Organization Nagoya City Rehabilitation Agency
Division name Division of Physical Therapy
Zip code 467-8622
Address 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL 052-835-3811
Homepage URL
Email Physical@nagoya-rehab.or.jp

Sponsor
Institute Nagoya City Rehabilitation Agency
Institute
Department

Funding Source
Organization no
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Suzuka University of Medical Science
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya City Rehabilitation Agency
Address 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
Tel 052-835-3811
Email soumubu@nagoya-rehab.or.jp

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
2017 Year 09 Month 01 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 12
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 No longer recruiting
Date of protocol fixation
2017 Year 08 Month 01 Day
Date of IRB
2017 Year 10 Month 02 Day
Anticipated trial start date
2017 Year 10 Month 02 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 04 Month 10 Day
Date trial data considered complete
2019 Year 04 Month 10 Day
Date analysis concluded
2019 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 08 Day
Last modified on
2019 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032624

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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