Patients with motor postural disorder associated with pediatric cerebral palsy, etc. Cerebral palsy (CP), Periventricular leukomalacia (PVL), Traumatic brain injury (TBI), Cerebrovascular disease (CVD),Meningitis, Encephalitis, Encephalopathy, Hydrocephalus, Neonatal asphyxia, Hypoxic encephalopathy, Nuclear icterus, Hyperbilirubinemia, Neuronal migration disorders, Chromosomal abnormality, Metabolic disorder
Conditions
Interventions
"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 exer
Standing and Walking exercises with/without a wearable cyborg HAL
Sponsors
Marushima Aiki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| (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 | — |
Contacts
Public ContactKoichi Hasimoto
University of Tsukuba
Outcome results
None listed