UMIN-CTR Clinical Trial

Public title

The relation between the long-term benefit of constraint-induced movement therapy and integrity of association fibers in chronic stroke patients: a pilot study

Acronym

The relation between the long-term benefit of constraint-induced movement therapy and integrity of association fibers

Scientific Title

The relation between the long-term benefit of constraint-induced movement therapy and integrity of association fibers in chronic stroke patients: a pilot study

Scientific Title:Acronym

The relation between the long-term benefit of constraint-induced movement therapy and integrity of association fibers

Region

Japan

Condition

Stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Fraction anisotropy value

Key secondary outcomes

Fugl-Meyer Assessment for upper extremitymotor activity log

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Takashi Takebayashi

Organization

Graduate course in Hyogo college of medicine

Division name

Department rehabilitation science

Zip code

Address

1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan

TEL

0798-45-6388

Email

takshi77@gmail.com

Name of contact person

1st name
Middle name
Last name	Takashi Takebayashi

Organization

Graduate course in Hyogo college of medicine

Division name

Department of rehabilitaiton science

Zip code

Address

1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan

TEL

0798-45-6388

Homepage URL

Email

takshi77@gmail.com

Institute

Hyogo college of medicine

Institute

Department

Personal name

Organization

the Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

08

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Suspended

Date of protocol fixation

2016

Year

02

Month

01

Day

Date of IRB

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

Other related information

This study is retrospective observation study for chronic stroke patients received CIMT from April, 2010 to January, 2016.

Registered date

2016

Year

08

Month

09

Day

Last modified on

2016

Year

08

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027136