UMIN-CTR Clinical Trial

Public title

The effect of inter-limb skill transfer on motor learning in patients with hemiparetic stroke: a randomized controlled trial.

Acronym

The effect of inter-limb skill transfer on motor learning in patients with hemiparetic stroke: a randomized controlled trial.

Scientific Title

The effect of inter-limb skill transfer on motor learning in patients with hemiparetic stroke: a randomized controlled trial.

Scientific Title:Acronym

The effect of inter-limb skill transfer on motor learning in patients with hemiparetic stroke: a randomized controlled trial.

Region

Japan

Condition

Hemiparetic stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of the study is to examine whether inter-limb skill transfer from the non-affected hand to the affected hand affect the motor learning process or not in patients with hemiparetic stroke.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

The scores of Nine Hole Peg Test pre and post 7-days intervention period, and at 7 days after the intervention.

Key secondary outcomes

We assess the following measures pre and post 7-days intervention period, and at 7 days after the intervention.
Modified Nine Hole Peg Test
Purdue Pegboard Test
Box and Block Test
Strength of pinch (lateral pinch, palmar pinch)
Fugl-Meyer Assessment Scale

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Intervention group
In addition to usual inpatient rehabilitation program, the patients assigned to the intervention group perform Nine Hole Peg Test 10 times a day using each hand in alternate order (total 20 times) for 7-days.

Interventions/Control_2

Control group
In addition to usual inpatient rehabilitation program, the patients assigned to the control group perform Nine Hole Peg Test 10 times a day using only the affected hand for 7-days.
In control group, patients takes a break for 30 seconds before each intervention (total 10 times a day) instead of doing intervention using the non-affected hand.

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The patients with first-ever stroke who are receiving inpatient rehabilitation programs in Tokyo Bay Rehabilitation Hospital.
More than 2 months after the onset of stroke.
Patients with hemiparesis.
Patients with the Stroke Impairment Assessment Set (SIAS) upper limb proximal motor function (knee-mouth test) score ranging from 3 to 5 and distal motor function (finger-function test) scores ranging from 3 to 5.
Patients who require over 30 seconds and less than 60 seconds to complete Nine Hole Peg Test.
The difference of time required to complete Nine Hole Peg Test between the non-affected hand and the affected hand is over 5 seconds.
Consent to participate in the study.

Key exclusion criteria

Cannot follow three step directions.
Severe pain in the upper extremity.
Musculoskeletal problems in the upper extremity.
Multiple brain lesions.
Lesion in the cerebellum.
Subarachnoid hemorrhage.
Central nervous system disease other than stroke.

Target sample size

24

Name of lead principal investigator

1st name
Middle name
Last name	Masashi Kumagai

Organization

Tokyo Bay Rehabilitation Hospital

Division name

Division of Occupational therapy

Zip code

Address

4-1-1 Yatsu, Narashino-shi, Chiba

TEL

047-453-9010

Email

m.kumagai.6126@gmail.com

Name of contact person

1st name
Middle name
Last name	Masashi Kumagai

Organization

Tokyo Bay Rehabilitation Hospital

Division name

Division of Occupational therapy

Zip code

Address

4-1-1 Yatsu, Narashino-shi, Chiba

TEL

047-453-9010

Homepage URL

Email

m.kumagai.6126@gmail.com

Institute

Tokyo Bay Rehabilitation Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Chiba University
Graduate School of Medicine

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

東京湾岸リハビリテーション病院（千葉県）
Tokyo Bay Rehabilitation Hospital (Chiba)

Date of disclosure of the study information

2014

Year

03

Month

05

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

Completed

Date of protocol fixation

2014

Year

01

Month

18

Day

Date of IRB

Anticipated trial start date

2014

Year

03

Month

06

Day

Last follow-up date

2015

Year

04

Month

04

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

03

Month

05

Day

Last modified on

2015

Year

12

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015576