UMIN-CTR Clinical Trial

Basic information
Public title	Kinematic study of the knee joint during gait in patients with stroke
Acronym	Kinematic study of the knee joint during gait in patients with stroke
Scientific Title	Kinematic study of the genu recurvatum during gait in patients with stroke
Scientific Title:Acronym	Kinematic study of the genu recurvatum during gait in patients with stroke
Region	Japan

Condition
Condition	Stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To classification genu recurvatum in patients with stroke based on the kinematic evaluation of gait and investigate the relationship between kinematic evaluation and clinical assessments.
Basic objectives2	Others
Basic objectives -Others	Cross-sectional study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Gait analysis (three-dimensional motion analysis and surface electromyogram)
Key secondary outcomes	Video analysis of gait, Fugl-Meyer Assessment, Stroke Impairment Assessment Set, Modified Ashworth Scale, muscle strength assessment

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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) First-time stroke patients 2) 90 to 120 days after onset 3) able to walk independently without assistive tool / brace 4) MMSE-J >= 23 points, and those who can understand the content of the research and gained consent
Key exclusion criteria	1) Those who newly started medication for spasticity during the evaluation time (eg. antispasmodic oral administration, botulinum toxin injection) 2) those with severe orthopedic disease affecting gait function 3) Those with serious cardiac disease: unstable angina, myocardial infarction shortly after symptom onset, decompensated congestive heart failure, acute cor pulmonale, uncontrolled arrhythmia, serious aortic stenosis, active myocarditis, endocarditis, etc. 4) Those with severe lower limb joint contracture affecting gait
Target sample size	80

Research contact person
Last name of lead principal investigator	1st name Takahito Middle name Last name Yasui
Organization	Tokyo Bay Rehabilitation Hospital
Division name	Department of Rehabilitation
Zip code	275-0026
Address	4-1-1, Yatsu, Narashino-shi, Chiba
TEL	047-453-9000
Email	t10.a.31k.y917@gmail.com

Public contact
1st name of contact person	1st name Takahito Middle name Last name Yasui
Organization	Tokyo Bay Rehabilitation Hospital
Division name	Department of Rehabilitation
Zip code	275-0026
Address	4-1-1, Yatsu, Narashino-shi, Chiba
TEL	047-453-9000
Homepage URL
Email	t10.a.31k.y917@gmail.com

Sponsor
Institute	Tokyo Bay Rehabilitation Hospital
Institute
Department

Funding Source
Organization	Tokyo Bay Rehabilitation Hospital
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	Tokyo Bay Rehabilitation Hospital
Address	4-1-1, Yatsu, Narashino-shi, Chiba
Tel	047-453-9000
Email	shinsakai@wanreha.net

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	2019 Year 04 Month 20 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
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	Enrolling by invitation
Date of protocol fixation	2018 Year 11 Month 19 Day
Date of IRB	2018 Year 11 Month 19 Day
Anticipated trial start date	2019 Year 04 Month 20 Day
Last follow-up date	2023 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The Classification of gait pattern in patients with genu recurvatum based on kinematic analysis / The comparison of clinical factors between patients with and without genu recurvatum.

Management information
Registered date	2019 Year 04 Month 10 Day
Last modified on	2019 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041442