Clinical Trial of Limb Wearable Cyborg HAL to Verify the Functional Effect for Motor Postural Disorders in the Stages of Child Development with Cerebral Palsy

JRCT ID: jRCT2032210573

Registered date:22/01/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients with motor postural disorder associated with pediatric cerebral palsy, etc.
• Date of first enrollment: 26/01/2022
• Target sample size: 45
• Study type: Interventional

Intervention(s)

"Intervention programs aimed at improving gross motor skills, mainly in standing and walking."
(1) Standing and sitting exercises (repetition of standing and sitting exercises, etc.)
(2) Standing exercises (balance exercises in the standing position, holding the standing position with hands-off, etc.)
(3) Walking exercises (applied walking, etc.)
Both the control group and the HAL group will implement the program once a day for 30 minutes, two to four times a week (12 times in total). Implementation of the intervention program for more than 15 minutes will be considered valid, and less than 15 minutes will be considered missing.

Outcome(s)

• Primary Outcome: The amount of change from baseline to the end of the intervention in the mean percentage score of domain D and domain E of the Gross Motor Function Measure (GMFM) (Central review)

Secondary Outcome

(1) to (14) will be decided by medical institutions, and (15) and (16) will be decided by Central review.
(1) The amount of change from baseline to the end of the intervention and 3 months later in the mean percentage score of domain D and domain E of the GMFM
(2) The amount of change from baseline to the end of the intervention in the total score of the 88 items of the GMFM (GMFM-88)
(3) The amount of change from baseline to the end of the intervention in the total score of the 66 items of the GMFM (GMFM-66)
(4) The amount of change from baseline to end of the intervention and at 3 months in percentage score of domain D of the GMFM
(5) The amount of change from baseline to end of the intervention and at 3 months in percentage score of domain E of the GMFM
(6) Improvement in the Gross Motor Function Classification System (GMFCS) from baseline to end of the intervention and at 3 months. However, improvement is defined as a change in the direction of a smaller GMFCS score (from II to I).
(7) The amount of change in 10 m comfortable walking speed from baseline to the end of the intervention and after 3 months
(8) The amount of change from baseline to the end of the intervention and after 3 months in the mean value of step length during the measurement of 10 m comfortable walking speed
(9) The amount of change from baseline to the end of the intervention and 3 months later in the mean value of walking rate during the measurement of 10 m comfortable walking speed
(10) The amount of change in 2-Minute Walk Distance (2MWD) from baseline to the end of the intervention and at 3 months
(11) The amount of change from baseline to end of intervention in muscle tone assessment (Modified Ashworth Scale: MAS). However, the change in the score will be evaluated by scoring the grade, with grade 0 being 5 points and grade 4 being 0 points.
(12) Improvement in muscle tone assessment MAS from baseline to the end of the intervention. However, the Improvement will be defined as a positive change in the score, with grade 0 being 5 points and grade 4 being 0 points.
(13) The amount of change in the Canadian occupational performance measure (COPM) from baseline to the end of the intervention
(14) The score at the end of the intervention on the Japanese version of the Decision Regret Scale (Japanese version of the DRS)
(15) The amount of change from baseline to end of the intervention in percentage score of domain D of the GMFM
(16) The amount of change from baseline to end of the intervention in percentage score of domain E of the GMFM

Key inclusion & exclusion criteria

• Age minimum: >= 5age old
• Age maximum: <= 15age old
• Gender: Both

Include criteria

Patients who meet all of the following criteria are eligible. (Inpatient or outpatient is not required)
(1) Patients with cerebral palsy, etc.
(2) Patients for whom written consent is obtained from a substitute and assent is obtained from the patient himself/herself in writing or orally
(3) Patients aged 5 to 15 years at the time of consent
(4) Patients with a Gross Motor Function Classification System (GMFCS) level II to III
(5) Patients who can walk a distance of 10 meters (walking aids may be used, but not a walker with a seat)
(6) Patients who have not undergone any lower limb surgery within one year
(7) Patients who are able to wear this device
Height should be within 100 to 150 cm. However, patients can wear the device even if their height is not within this range, as long as their body sizes, such as thigh length, lower leg length, and waist width, match. Even if the height is within the range, if the body does not fit the size, HAL (size S) may be worn.
Weight should be within 15 to 50 kg

Exclude criteria

Subjects who do not meet any of the following criteria will be excluded and will not be eligible for this study
(1) Patients who present motor postural disorder due to progressive disease or lesion
(2) Patients who have had a bioelectrical-driven device (e.g. non-medical HAL for well-being model) within 1 year, or have had the same device 6 times or more even if more than 1 year has passed
(3) Patients who have difficulty in voluntary limb movement according to instructions due to impaired consciousness or severe intellectual disability
(4) Patients with serious hepatic, renal, cardiovascular, or respiratory disorders (to be determined with reference to Grade 3 in the "Criteria for Classification of Severity of Adverse Reactions to Drugs and Other Products", Drug Safety No. 80, Notification of the Director of the Safety Division, Pharmaceutical Affairs Bureau, Ministry of Health, Labour and Welfare)
(5) Patients with malignant tumors that have not been cured
(6) Patients who cannot put the bioelectrode of this device due to skin diseases, etc
(7) Patients with bleeding tendency, osteoporosis, or other complications that may cause problems in standing and walking exercises
(8) Patients who are pregnant or who may be pregnant. Also, patients who wish to become pregnant during the study period
(9) Patients who have participated in other clinical trials within 6 months prior to enrollment
(10) Patients who are unable to operate the device in the cybernic voluntary control (CVC) mode at either the hip or knee joint
(11) Patients whose operation of an active medical device or electronic device (e.g. pacemaker) implanted in the body is affected by HAL operation
(12) Other patients who are judged by the investigator or sub-investigator to be inappropriate to participate in this study

Related Information

• Primary Sponsor: Marushima Aiki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development