UMIN-ICDS Clinical Trial

Public title

A study on the effects of gait training using tha HAL lower limb type on gait

Acronym

A study of gait training using tha HAL

Scientific Title

Development of an effective training method using the lower-limb type of Hybrid Assistive Limb

Scientific Title:Acronym

HAL Training Development Study

Region

Japan

Condition

amyotrophic lateral sclerosis (ALS), spinal muscular atrophy, spinobulbar muscular atrophy, Charcot-Marie-Tooth disease, inclusion body myositis, distal myopathy, muscular dystrophy, congenital myopathy, hereditary spastic paraplegia, and HTLV-1

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The HAL medical lower-limb type became covered by medical insurance in January 2016, targeting 10 diseases: amyotrophic lateral sclerosis (ALS), spinal muscular atrophy, spinobulbar muscular atrophy, Charcot-Marie-Tooth disease, inclusion body myositis, distal myopathy, muscular dystrophy, congenital myopathy, hereditary spastic paraplegia, and HTLV-1-associated myelopathy. It has been shown that patients with these disorders causing voluntary movement impairment can improve their walking function by performing gait training while wearing HAL. However, no effective training programs have been proposed for individual patients, such as the optimal frequency and duration of training for each disease, the best training menu for each level of severity, or how long the walking improvement effect lasts. Establishing effective training programs for individuals requires accumulating and analyzing data from experienced cases, so this study was planned to help treat diseases and improve activities of daily living (ADL).

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Evaluate the following items for each training session

10mWT: 10-Meter Walk Test
2mWT: 2-Meter Walk Test
TUG: Timed Up & Go Test
BBS: Berg Balance Scale
ADL (BI): Barthel Index
ADL (FIM): Functional Independence Measure
MMSE: Mini-Mental State Examination
VICON: 3D Motion Analysis System
Delsys: Multi-Channel Electromyography System
VAS: Visual Analogue Scale
ECOG-PS: Eastern Cooperative Oncology Group Performance Status
Active style Pro
IPAQ: International Physical Activity Questionnaire
FAC: Functional Ambulation Categories
EQ-5D-5L: European Quality of Life 5-Dimensions 5-Level Version
Opal V2R (APDM IMU system)
RECORE

Key secondary outcomes

Study type

Interventional

Basic design

n-of-1

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Participants will perform a 40-minute walking task while wearing the Hybrid Assistive Limb (HAL) Medical Type (Lower Limb Model). As a control condition, the same participants will perform a 40-minute conventional walking task without HAL. Both conditions will be executed in an ABAB sequence, during which surface electromyography (sEMG) will be measured during walking under each condition. Furthermore, in the HAL condition, the device will be removed immediately after completing the walking task, and sEMG will be measured during walking immediately post-removal.

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

5

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Patients with one of the 8 diseases already covered by insurance (spinal muscular atrophy, spinal and bulbar muscular atrophy, amyotrophic lateral sclerosis with slowly progressive lower limb symptoms, Charcot-Marie-Tooth disease, distal myopathy, congenital myopathy, muscular dystrophy, and inclusion body myositis) or the 2 diseases approved for insurance coverage (hereditary spastic paraplegia and HTLV-1-associated myelopathy), who have obtained the approval of their primary physician for the primary disease.
2) Patients who are capable of providing written informed consent. If the patient has difficulty writing, a proxy may sign on their behalf; if the patient is unable to provide consent, written consent may be obtained from a legally acceptable representative. For pediatric patients (aged 5 to 17 years), informed assent should be obtained whenever possible.
3) Patients who had no issues with the fitting of HAL during the pre-observation period.

Key exclusion criteria

1. Patients who have participated in other studies within 12 weeks prior to the start of this clinical study.
2. Patients who are judged to be inappropriate for participation in the study by the principal investigator, sub-investigators, or collaborators.
3. Patients who are expected to have difficulty wearing the HAL or undergoing gait training due to severe osteoarthritis, spondylosis deformans, scoliosis, osteoporosis, skin diseases, or other conditions.
4. Patients with severe complications (e.g., cardiac disease, hepatic disease, renal disease).
5. Patients with a history or suspicion of malignant tumor within 5 years prior to the date of informed consent.
6. Patients who are pregnant or suspected of being pregnant.
7. Patients who do not have the capacity to give voluntary consent.
8. Patients from whom written informed consent cannot be obtained.

Target sample size

100

Name of lead principal investigator

1st name	matsui
Middle name
Last name	ayano

Organization

National Center Hospital of Neurology and Psychiatry

Division name

orthopedic surgery

Zip code

1878551

Address

4-1-1 Ogawahigashicho, Kodaira-shi, Tokyo

TEL

0423412711

Email

matsuura@ncnp.go.jp

Name of contact person

1st name	matsuura
Middle name
Last name	takeshi

Organization

National Center Hospital of Neurology and Psychiatry

Division name

Department of Physical Rehabilitation

Zip code

1878551

Address

4-1-1 Ogawahigashicho, Kodaira-shi, Tokyo

TEL

0423412711

Homepage URL

Email

matsuura@ncnp.go.jp

Institute

National Center Hospital of Neurology and Psychiatry

Institute

Department

Personal name

Organization

National Center Hospital of Neurology and Psychiatry

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

National Center Hospital of Neurology and Psychiatry

Address

4-1-1 Ogawahigashicho, Kodaira-shi, Tokyo

Tel

0423412711

Email

matsuura@ncnp.go.jp

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

2026

Year

11

Month

03

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

2023

Year

09

Month

28

Day

Date of IRB

2023

Year

09

Month

28

Day

Anticipated trial start date

2023

Year

09

Month

28

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

10

Month

21

Day

Last modified on

2026

Year

11

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072324