UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041280
Receipt number R000047137
Scientific Title Effects of gait training with a voluntary driven Wearable Cyborg, Hybrid Assistive Limb (HAL), in patients with spinal cord disease
Date of disclosure of the study information 2020/08/03
Last modified on 2024/02/07 13:15:42

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Basic information

Public title

Effects of gait training with a voluntary driven Wearable Cyborg, Hybrid Assistive Limb (HAL), in patients with spinal cord disease

Acronym

Treatment with Hybrid Assistive Limb (HAL), in patients with spinal cord disease

Scientific Title

Effects of gait training with a voluntary driven Wearable Cyborg, Hybrid Assistive Limb (HAL), in patients with spinal cord disease

Scientific Title:Acronym

Treatment with Hybrid Assistive Limb (HAL), in patients with spinal cord disease

Region

Japan


Condition

Condition

spinal cord disease

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the effects of HAL-supported gait training in patients with spinal cord disease

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The parameters were measured before
treatment, 3 month after treatment.
1. JOA score
2. ADL score(Barthel index,Functional Independence Measure)
3. Patient-standing QOL score(SF36,EuroQOL-5D)
4. 10-m walk test
5. 6-min walk test
6. Tilt of the trunk and angle of hips, knees and ankles during walking
7. Lower extremity muscle activity during walking (gluteus maximus, gluteus medius, quadriceps, hamstring, tibialis anterior, triceps surae)
8. Signal intensity of nerve conduction path in simple MRI images (Synthetic MRI, Quantitative Susceptibility Mapping, diffusion tensor image, 3D-MRI, 3D-FLAIR, Finger-Printing)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

In group A, walking rehabilitation using HAL is performed for 3 months, and then conventional walking rehabilitation centered on assisted walking training by a therapist is performed for 3 months.

Interventions/Control_2

In Group B, conversely, conventional walking rehabilitation is performed for 3 months, and then walking rehabilitation using HAL is performed for 3 months.

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

15 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

More than 6 months have passed since the onset of spinal cord disease or surgical treatment.
Lower limb dysfunction due to spinal cord disease remains, resulting in a decline in walking ability.
As for spinal cord injury, ASIA dysfunction scales C and D are used.
It is possible to walk for 10 meters or more without support or using a walking aid.

Key exclusion criteria

Other central nervous system diseases, nerve/muscle diseases, or locomotor system diseases clearly influence the deterioration of walking ability.
HAL is difficult to wear due to severe deformation of limbs and trunk caused by osteoarthritis, spondylosis, scoliosis, etc.
It is difficult to follow the instructions due to severe dementia.
Has respiratory, circulatory, and metabolic system dysfunction, bleeding tendency, and osteoporosis, which are problems in training.
Biomedical electrodes cannot be attached due to skin diseases.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Hiroaki
Middle name
Last name Ishiyama

Organization

Hirosaki University, graduate school of Medicine

Division name

Dept. of Rehabilitation Medicine

Zip code

036-8562

Address

5 Zaifu-cho, Hirosaki, AOMORI

TEL

0172-33-5111

Email

a.b.c.hiro77@gmail.com


Public contact

Name of contact person

1st name Eiichi
Middle name
Last name Tsuda

Organization

Hirosaki University, Graduate School of Medicine

Division name

Dept. of Rehabilitation Medicine

Zip code

036-8562

Address

5 Saifu-cho, Hirosaki, AOMORI

TEL

0172-33-5111

Homepage URL


Email

eiichi@hirosaki-u.ac.jp


Sponsor or person

Institute

Dept of Rehabilitation Medicine, Hirosaki University, Graduate school of Medicine

Institute

Department

Personal name



Funding Source

Organization

NA

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hirosaki University, Graduate School of Medicine

Address

5 Zaifu-cho, Hirosaki, AOMORI

Tel

0172-33-5111

Email

rinri@hirosaki-u.ac.jp


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

2020 Year 08 Month 03 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

10

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



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2020 Year 07 Month 22 Day

Date of IRB

2020 Year 07 Month 22 Day

Anticipated trial start date

2020 Year 07 Month 31 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 08 Month 03 Day

Last modified on

2024 Year 02 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047137


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name