UMIN-CTR Clinical Trial

Public title

The evaluation of the neurofeedback effect of single-joint Hybrid Assistive Limb(HAL) robot suit in stroke patients with upper limb disability by Optical Functional Brain Imaging

Acronym

The evaluation of the neurofeedback effect of HAL-SJ in stroke patients with upper limb disability by Optical Functional Brain Imaging

Scientific Title

The evaluation of the neurofeedback effect of single-joint Hybrid Assistive Limb(HAL) robot suit in stroke patients with upper limb disability by Optical Functional Brain Imaging

Scientific Title:Acronym

The evaluation of the neurofeedback effect of HAL-SJ in stroke patients with upper limb disability by Optical Functional Brain Imaging

Region

Japan

Condition

Stroke

Classification by specialty

Neurology	Neurosurgery	Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the neurofeedback effect of HAL-SJ in acute stroke patient with upper limb disability using functional near infrared spectroscopy (fNIRS)

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Changes of hemoglobin concentration in the cerebral cortex measured by fNIRS before and after rehabilitation with HAL

Key secondary outcomes

1.Changes of following parameters during before and after rehabilitation with HAL
a. Action Research Arm Test (ARAT), Fugl-Meyer Assessment (FMA), Motor Activity Log (MAL)
b. Barthel Index, Functional Independence Measure (FIM)
c. Modified Ashworth scale (MAS)
d. The number of flexion/extension movement in elbow joint
e. Visual Analogue Scale (VAS) for patients with upper limb pain

2.Patient's and therapist's global impression scale for HAL-SJ

3.Parameters of HAL-SJ during rehabilitation

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

The single-joint HAL robot suit (HAL-SJ) made by CYBERDYNE INC. is used.
Patients perform one task for 20-40 min and three or five times per week added on the HAL rehabilitation.
The HbO and HHb levels are measured by fNIRS before and after HAL-SJ treatment on the same day.
Patients who have received HAL training more than five times receive clinical evaluation and fNIRS assessment. At more than six months after hospital transfer, patients receive a long term follow-up clinical evaluation and fNIRS assessment.

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

Stroke patients treated in acute phase at our hospital, who have upper-limb dysfunction

Key exclusion criteria

1.Patients who use respirator, oxygen therapy or cardiac pacemaker.
2.Patients who have severe kidney dysfunction, heart disease or respiratory disease.
3.Patients who are unable to understand the methods of clinical intervention because of severe cognitive impairment or mental disorder.
4.Patients who cannot attach electrode because of dermatosis.
5.Patients with severe restriction of motion range of upper limb joint because of contracture.
6.Patients who have dysfunction of shoulder and/or elbow, severe pain.
7.Patients ineligible to the study based on investigator's decision.

Target sample size

50

Name of lead principal investigator

1st name	Tooru
Middle name
Last name	Inoue

Organization

Fukuoka University Hospital

Division name

Department of Neurosurgery

Zip code

814-0180

Address

7-45-1, Nanakuma, Johnan-ku, Fukuoka, Japan

TEL

092-801-1011

Email

toinoue@fukuoka-u.ac.jp

Name of contact person

1st name	Takashi
Middle name
Last name	Morishita

Organization

Fukuoka University Hospital

Division name

Department of Neurosurgery

Zip code

814-0180

Address

7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan

TEL

092-801-1011

Homepage URL

Email

tmorishita@fukuoka-u.ac.jp

Institute

Fukuoka University

Institute

Department

Personal name

Organization

Fukuoka University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Fukuoka University Hospital

Address

7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan

Tel

092-801-1011

Email

tmorishita@fukuoka-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

福岡大学病院（福岡県）

Date of disclosure of the study information

2017

Year

06

Month

29

Day

URL releasing protocol

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0191361

Publication of results

Published

URL related to results and publications

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0191361

Number of participants that the trial has enrolled

10

Results

We finally included 10 patients (eight men, two women; mean age: 66.8 years). The mean number of flexion/extension movements within 15 s increased significantly from 4.2 to 5.3 immediately after training. fNIRS showed increased cortical activation in the primary motor cortex of the ipsilesional hemisphere immediately after HAL-SJ treatment compared to the baseline condition.

Results date posted

2022

Year

03

Month

08

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2018

Year

01

Month

16

Day

Baseline Characteristics

We included 10 patients (two women and eight men; mean age: 66.8 years). All study participants were right handed. Of the 10 patients, eight and two had ischemic and hemor- rhagic stroke, respectively. Stroke lesions were detected in the left and right hemispheres in eight and two patients, respectively. All of eight ischemic stroke cases had an ischemic lesion in the corona radiata, and one of two hemorrhagic stroke patients had a lesion in the thalamus and the other had a lesion in the putamen.

Participant flow

A total of consecutive 343 patients with subacute stroke admitted to our hospital were assessed in this study during the period between January 2016 and March 2017. We included patients between 20 and 80 years old (excluded, n = 72). We excluded patients with severe systemicconditions (n = 66), severe cognitive impairment and/or altered consciousness who were unable to follow instructions (n = 41), and severe pain in the affected limb (n = 5). In addition, we excluded patients who were neurologically intact (n = 97) or had mild disturbance (n = 19), and nine patients for miscellaneous reasons such as social issues. Finally, 10 patients were included in the study.

Adverse events

None.

Outcome measures

HbO2 and HHb levels for fNIRS　As the baseline clinical evaluation, the mean National Institutes of Health Stroke Scale (NIHSS) score, Fugl-Meyer Assessment for upper extremities (FMA) score, Action Research Arm Test (ARAT), and Mini-Mental State Examination (MMSE)

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2017

Year

05

Month

08

Day

Date of IRB

2017

Year

06

Month

30

Day

Anticipated trial start date

2017

Year

07

Month

01

Day

Last follow-up date

2017

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

06

Month

28

Day

Last modified on

2022

Year

03

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032032