UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of robot therapy on arm and finger function in sub-acute stroke patients with hemiplegia.
Title of the study (Brief title)	Effect of robot therapy on arm and finger function in sub-acute stroke patients with hemiplegia.
Region	Japan

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

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Shinichi Shimada
Organization	Itami Kousei Neurosurgical Hospital
Division name	Department of Neurosurgery
Address	1-300-1, Nishino, Itami-shi, Hyogo
TEL	664-0028
Email	shimada_s@itami-kousei.jp

Public contact
Name of contact person	Takashi Takebayashi
Organization	Kibi International university
Division name	School of health science and social welf are
Address	Iga 8, Takahashi, Okayama
TEL	0866-22-9894
Homepage URL
Email	takshi77@gmail.com

Sponsor
Institute	Kibi international university
Institute
Department

Funding Source
Organization	Teijin pharma Limited
Organization
Division
Category of Funding Organization	Profit organization
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 09 Month 23 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 08 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 09 Month 22 Day
Last modified on	2016 Year 09 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027773