NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032180149

Registered date:22/02/2019

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

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedStroke, brain/spinal cord injury, brain/spinal cord tumor, neuromuscular disease
Date of first enrollment22/07/2014
Target sample size285
Countries of recruitment
Study typeInterventional
Intervention(s)The treatment of functional recovery using HAL approximately 2 times for a week.

Outcome(s)

Primary Outcome1. Adverse event 2. Failure of HAL and ancillary equipment 3. Feasibility of study protocol
Secondary Outcome1) 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 maximumNot applicable
GenderBoth
Include criteriaPatients 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 criteriaPatients 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

Contact

Public contact
Name Aiki Marushima
Address 2-1-1 Amakubo, Tsukuba-city, Ibaraki Ibaraki Japan 305-8576
Telephone +81-29-853-3220
E-mail aiki.marushima@md.tsukuba.ac.jp
Affiliation University of Tsukuba Hospital
Scientific contact
Name Masashi Yamazaki
Address 2-1-1 Amakubo, Tsukuba-city, Ibaraki Ibaraki Japan 305-8576
Telephone +81-29-853-3219
E-mail masashiy@md.tsukuba.ac.jp
Affiliation University of Tsukuba Hospital