UMIN-CTR Clinical Trial

Public title

Effect of robot therapy on arm and finger function in sub-acute stroke patients with hemiplegia.

Acronym

Effect of robot therapy on arm and finger function in sub-acute stroke patients with hemiplegia.

Scientific Title

Effect of robot therapy on arm and finger function in sub-acute stroke patients with hemiplegia.

Scientific Title:Acronym

Effect of robot therapy on arm and finger function in sub-acute stroke patients with hemiplegia.

Region

Japan

Condition

Stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Stroke is a symptom that exhibits sequelae, such as long-term movement disorders. Due to the success of the exercise therapy induced by the Constraint-induced movement therapy that have emerged since 1980, we have discussed need to perform a lot of intensive exercises for the paralyzed hand. However, especially in Japanese medical insurance system, some medical clinics may not have the medical resources to implement exercise more than 1 hour per day for upper limb. Therefore, in Europe and the United States, in order to implement intensive therapy for the upper limb paralysis after a stroke, since the 1990s, they begun to develop the robot for exercise in upper extremity. In 2010, Lo showed that the robot therapy is as effect on the upper limb paralysis after stroke as intervention by the therapist, and that intervention by the robot has significantly less economic burden than that of the therapist. Similarly, in Japan, and test for the efficacy of the robot has done. We provided the robot therapy as a self-exercise in addition to a conventional therapy in order to increase the amount of therapy for sub-acute stroke patients. As a result, we showed that the robot therapy significantly improved upper limb function than a conventional self-exercise. However, we showed that the ReoGo did not have effect on hand function because it was developed to improve shoulder and elbow function. In addition, in the guidelines of the Lancet issued in 2011, they showed that it has effect on finger function in the B rank, and the effect is not yet clear. From the above, it is one of the important issues to investigate the effect of the robot therapy on finger function in order to administer intensive therapy in finger function for stroke patients with upper limb paralysis. Therefore, we evaluate the effect of the intensive therapy using the robot called Hand of Hope which it is enable to do a self-exercise in the finger for sub-acute stroke patients with upper limb paralysis.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Active and passive range of motion of the fingers, arm and finger motor function in test using Fugl-Meyer Assessment and Action research arm test

Key secondary outcomes

A structured participation interview of real-world arm use in test using Motor Activity Log, amount of activity of hand by using accelerometer (UW-301BT, Hitachi Systems, Ltd., Japan) , subjective well-being by a subjective well-being scale

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

All subjects received study treatment for 2 hours per day for 14 consecutive days. Subjects received standard occupational therapy treatment for 1 hour per day and self-training exercise by using the Hand of Hope for 1 hour per day. The Hand of Hope facilitates muscle reeducation by both amplifying and rewarding a patient with desired motion in concert with his or her own muscle signal. The patient can self-initiates movement through their often very weak voluntary EMG signals that indicate intention to move. Through repetitive training using the system, a paralyzed person, such as one who has suffered a stroke can perform activities of daily living including opening, holding and picking. This can change the type of tasks on the virtual reality, it can be adjusted difficulty of tasks. In addition to that, according to the each of the subject's upper limb function, occupational therapists to select tasks and implement intervention. Standard occupational therapy included a task-oriented training that direct subject attention and effort toward the hemiparetic upper extremity and minimized the use of the unaffected upper extremity during functional activites, muscle tone adjustment by neurodevelopmental techniques, compensatory techniques for Activities daily of living, stretching, range of motion, and upper extremity strength.

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

Subject is the person who meets the following criteria. The inclusion criteria were 1 month and less than one week after an ischaemic or haemorrhagic stroke, hemiparesis of the affected limb.

Key exclusion criteria

The exclusion criteria were (1) brain stem lesions and the both sides hemisphere damage, (2) balance disorder unable to do self-exercise, (3) dementia, mental illnesss, <24 on the Mini Mental State Examination, (4) on the Modified Ashworth Scale, (5) aphasia, apraxia and agnosia unable to do exercise, (6) complications that are not able to control and not expected to survive 1 year due to other illnesss, (7) shoulder, elbow and hand strong contracture.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Shinichi Shimada

Organization

Itami Kousei Neurosurgical Hospital

Division name

Department of Neurosurgery

Zip code

Address

1-300-1, Nishino, Itami-shi, Hyogo

TEL

664-0028

Email

shimada_s@itami-kousei.jp

Name of contact person

1st name
Middle name
Last name	Takashi Takebayashi

Organization

Kibi International university

Division name

School of health science and social welf are

Zip code

Address

Iga 8, Takahashi, Okayama

TEL

0866-22-9894

Homepage URL

Email

takshi77@gmail.com

Institute

Kibi international university

Institute

Department

Personal name

Organization

Teijin pharma Limited

Organization

Division

Category of Funding Organization

Profit organization

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

09

Month

23

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

Open public recruiting

Date of protocol fixation

2016

Year

08

Month

31

Day

Date of IRB

Anticipated trial start date

2016

Year

10

Month

31

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

09

Month

22

Day

Last modified on

2016

Year

09

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027773