The feasibility and safety study of the functional recovery therapy using a HAL for the central motor dysfunction.

JRCT ID: jRCTs032180149

Registered date:22/02/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Stroke, brain/spinal cord injury, brain/spinal cord tumor, neuromuscular disease
• Date of first enrollment: 22/07/2014
• Target sample size: 285
• Study type: Interventional
• Intervention(s): The treatment of functional recovery using HAL approximately 2 times for a week.

Outcome(s)

Primary Outcome

1. Adverse event
2. Failure of HAL and ancillary equipment
3. Feasibility of study protocol

Secondary Outcome

1) Vital sign
Blood pressure, heart rate, respiratory rate, electrocardiogram, SpO2
2) Evaluation of physical function
Active/passive range of motion
Muscle tone score (MAS)
Manual Muscle Testing (MMT)
Fugl-Meyer Assessment (brain disease)
Upper arm/thigh circumference length
10 m walking test
2 minutes walking distance
Motion, gait evaluation
NIHSS score (acute phase of brain disease)
ASIA score (acute phase of spinal cord disease)
3) Daily living behavior/caregiving degree evaluation
Independence degree of daily life (bedridden degree)
Modified Rankin Scale (mRS) (cerebrospinal disorders recovery period)
Barthel Index (cerebrospinal disorders recovery period)
Functional Independence measure (cerebrospinal disordersrecovery period)
4) Neurophysiological examination
Motor evoked potential (TMS-MEP)
Somatosensory evoked potential (SEP)
H wave, H/M ratio, F wave
Biopotential
Electroencephalogram
5) Neuro radiology evaluation
fMRI
DTI (FA value), Tractgraphy
6) mental/psychological/cognitive function evaluation
NASA-TLX
Motivation score
HDS-R
MMSE
Questionnaire (sense of security, satisfaction, expectation)
7) Satisfaction level of subjects concerning use of HAL (questionnaire)
8) Operator's evaluation on the use of HAL (questionnaire)
9) Operation monitoring data of HAL
10) ICU, HCU entry period, hospitalization period

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients satisfying all of the following criteria are subject to this clinical trial.
1. A patient can consent by a document. If the handwriting is difficult due to the primary disease, it is assumed to obtain a document consent from ghost-writing user.
2. A patient 16 years of age or older. The consent of the legal representative's is needed for the patients of minors 16-19 years of age.
3. A patient who are hospitalized in the general ward, ICU or HCU.
4. A patient can wear HAL, weighing 40-100 kg, height is 150-190 cm.
5. A patient who can be hospitalized continuously along the test schedule.

Exclude criteria

Patients who conflict with one of the following criteria are excluded and not subject to this clinical study.
1. It is difficult to perform the volantary movement of the limbs in accordance with the instructions due to the disturbance of consciousness or dementia.
2. It is difficult to wear HAL or train using HAL due to the severe deformation of the skeletal system.
3. A patient has a complication, which can disturb the treatment using HAL.
4. The biological edectrode for HAL can not be affixed to patient's skin due to the skin disease.
5. A patient who participated in other studies within 12 weeks of the start of this clinical study.
6. A patient whose clinical trial investigator or clinical trial sharing doctor judged inappropriate participation in this study.

Related Information

• Primary Sponsor: Hada Yasushi
• Source(s) of Monetary Support: Grant-in-Aid for Scientific Research (C)
• Secondary ID(s): UMIN000014336