UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The relation between the long-term benefit of constraint-induced movement therapy and integrity of association fibers in chronic stroke patients: a pilot study
Title of the study (Brief title)	The relation between the long-term benefit of constraint-induced movement therapy and integrity of association fibers
Region	Japan

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

Objectives
Narrative objectives1	Constraint induced movement therapy (CIMT) improves paretic upper extremity deficits in stroke patients. The short term benefit of CIMT for upper extremity deficits in stroke patients has been shown by many randomized controlled trials (Miller et al. 2010, Langhorn et al. 2011). Additionally, our previous study and few others have shown long term benefits (lasting 6 months to 2 years after the intervention) of CIMT for upper extremity deficits in stroke patients (Takebayashi et al. 2013, Wolf et al. 2006, Wolf et al. 2008). Plasticity of the central nervous system is one potential mechanism underlying the recovery of upper extremity function after CIMT. Several characteristics of association fibers (white matter tracts) evaluated by diffusion tensor imaging (DTI) scans have been related to the severity of motor deficits after central nervous system damage (Lee et al. 2005, Sterr et al. 2010, Radlinska et al. 2010). The fractional anisotropy (FA) value obtained from DTI scans is related to the integrity of association fibers. FA value reflects the random motion of water molecules, and low FA values reflect extensive damage to association fibers. In adult stroke patients, studies have shown a strong positive relation between the extent of motor deficit and FA quantified using DTI, particularly in the corona radiate (Zhu, 2010), cerebral crus (Koyama et al. 2013), and posterior limb of internal capsule (PLCI) (Qui et al. 2011). Additionally, FA value of the corticospinal tract predicted the short term benefit of CIMT for upper extremity motor deficits in adult stroke patients (Marumoto et al. 2013, Sterr et al. 2014). However, the mechanism by which CIMT induces long term benefits has not yet been studied. The aim of this study was to quantify the relation between the short and long term benefits of CIMT and the FA value of association fibers evaluated by DTI in adult chronic stroke patients with hemiparesis.
Basic objectives2	Others
Basic objectives -Others	The aim of this study was to quantify the relation between the short- and long-term benefits of CIMT and the FA value of association fibers evaluated by DTI in adult chronic stroke patients with hemiparesis. This study is to define the mechanism of long-term benefits of CIMT.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fraction anisotropy value
Key secondary outcomes	Fugl-Meyer Assessment for upper extremitymotor activity log

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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Participants were chronic stroke patients (>7 months from stroke onset) with hemiparesis who received CIMT as part of their outpatient medical care at Hyogo College of Medicine Hospital between April 2010 and January 2016.
Key exclusion criteria	1) age <20 years at time of treatment, 2) bilateral or brain stem infarct or hemorrhage, 3) voluntary extension <10 degree at metacarpophalangeal and interphalangeal joints of three or more fingers and voluntary extension <20 degree at one wrist, 4) severe balance or walking disorder, indicated by the need for assistance for standing, walking, or using the toilet, 5) substantial use of the affected upper extremity before the intervention, indicated by a score >2.5 points on the Amount of Use (AOU) scale of the Motor Activity Log (MAL), 6) clear signs of dementia or cognitive disorder, indicated by a score <24 points on the Mini-Mental State Examination), 7) severe aphasia or apraxia that inhibited performance of the intervention, 8) presence of another uncontrolled medical condition or severe end-stage disease, 9) severe contraction around the shoulder, elbow, wrist, or finger, 10) absence of magnetic resonance imaging (MRI) data before the intervention, and 11) missing clinical assessment data at the 6-month follow-up time point.
Target sample size	13

Research contact person
Name of lead principal investigator	Takashi Takebayashi
Organization	Graduate course in Hyogo college of medicine
Division name	Department rehabilitation science
Address	1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL	0798-45-6388
Email	takshi77@gmail.com

Public contact
Name of contact person	Takashi Takebayashi
Organization	Graduate course in Hyogo college of medicine
Division name	Department of rehabilitaiton science
Address	1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL	0798-45-6388
Homepage URL
Email	takshi77@gmail.com

Sponsor
Institute	Hyogo college of medicine
Institute
Department

Funding Source
Organization	the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 08 Month 09 Day

Progress
Recruitment status	Suspended
Date of protocol fixation	2016 Year 02 Month 01 Day
Anticipated trial start date	2016 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This study is retrospective observation study for chronic stroke patients received CIMT from April, 2010 to January, 2016.

Management information
Registered date	2016 Year 08 Month 09 Day
Last modified on	2016 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027136