JPRN-jRCT2032210573
Active, not recruiting
Phase 3
Investigator-initiated clinical trial of a wearable cyborg HAL voluntary controlled by bioelectrical signals to verify the effectiveness of growth motor function for motor postural disorders related to standing and walking for pediatric patients with cerebral palsy: A multicenter, randomized, parallel-group comparison study - LIFE-STAGE trial
Marushima Aiki0 sites45 target enrollmentJanuary 22, 2022
ConditionsPatients 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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Patients with motor postural disorder associated with pediatric cerebral palsy, etc.
- Sponsor
- Marushima Aiki
- Enrollment
- 45
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 2
A clinical trial of a novel skin reconstruction treatment for GCMN.Congenital giant melanocytic nevusJPRN-jRCT2052210044Morimoto Naoki3
Completed
Not Applicable
Investigator-Initiated Clinical Study of Wearable Assistive Robot for Lower Limbs Controlled Voluntarily by Bioelectric Signals etc., (Hybrid Assistive Limb [HAL]-HN01) as a New Medical Device to Delay Progression of Intractable Rare Neuromuscular Diseases-A Multicenter Randomized Controlled Parallel-Group Study to Evaluate the Short-Term Gait Improvement Effect on Ambulation Disability Caused by Spastic Paraplegia such as HTLV-1-Associated Myelopathy (HAM) etc.-(Study NCY-2001)JPRN-jRCT1092220204Takashi Nakajima40
Active, not recruiting
Phase 1
Investigator-initiated clinical research trial on the effects of 5% Minoxidil topical foam on gene expression, hair growth and scalp microenvironment in men with androgenetic alopeciaAndrogenetic Alopecia Hamilton-Norwood IIIv-IV male patientsMedDRA version: 16.1Level: PTClassification code 10068168Term: Androgenetic alopeciaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]EUCTR2013-004130-15-DECharité-Universitätsmedizin Berlin, Department of Dermatology, Clinical Research Center for Hair and Skin Science12
Completed
Phase 1
A proof-of-concept clinical trial to evaluate the efficacy and safety of combined use of cefadroxil and tyrosine kinase inhibitors in minimal residual disease-positive patients with chronic phase chronic myelogenous leukemiaChronic myelogenous leukemiaJPRN-UMIN000027904Department of Hematology and Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University.
Completed
Phase 1
A Clinical study on quadrivalent Human Papilloma virus vaccineHealth Condition 1: Z23- Encounter for immunizationCTRI/2017/02/007785Serum Institute of India Pvt Ltd47