spasticity associated with cerebral palsy cerebral palsy, spasticity
Conditions
Interventions
The study period consists of a 0-4 week pre-observation period, a 12 week period of treatment with botulinum toxin alone, a 12 week period between treatments, and a 12 week period of combined treatmen
D001905
botulinum toxin, Radial Pressure Wave
Sponsors
Harada Risa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be eligible for the study. (1) Patients aged 2 years or older. (2) Patients with spasticity of both adductor muscles due to cerebral palsy. (3) Patients who can provide written consent for participation in the study. If the patient is unable to provide consent due to mental retardation or other reasons, the consent of a substitute decision-maker will be obtained. (4) For patients who have already received botulinum toxin treatment, at least 12 weeks must have passed since the last botulinum administration at the time of consent.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study. (1) Patients who have received intrathecal baclofen therapy. (2) Patients who are allergic to botulinum toxin. (3) Patients who have a tendency to bleed, as indicated by a recent examination. (4) Patients with a blood coagulation disorder (including local thrombosis). (5) Patients taking oral anticoagulants (6) Patients who have had the onset of the disease causing spasticity within the last 6 months (7) Patients who have had orthopedic spasticity suppression treatment for the hip within the last year (8) Patients who have participated in another interventional study within the last 4 months (9) Patients with systemic neuromuscular junction disorders (10) Pregnant women, women who may be pregnant, and breastfeeding women (11) Patients with a history of hypersensitivity to the ingredients of Botox (12) Patients who have received corticosteroid injections in the treatment area (13) Patients with tendon damage, tumors, or infections in the adductor muscles. (14) Patients who are judged to be unsuitable by the person in charge of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The modified Ashworth Scale (MAS) for both adductor muscles is the primary endpoint. The difference in MAS between baseline and 12 weeks after treatment with botulinum toxin alone will be compared with the difference in MAS between baseline and 12 weeks after treatment with botulinum toxin and radial pressure wave. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy evaluation items The patient's improvement in movement will be evaluated based on the MAS of both adductor muscles and the course of MAS at each visit after treatment, the range of motion of the hip joint in passive abduction, the J-ZBI, which is a measure of the burden of care, symptoms, videos, etc., at each visit after treatment. In cases where the patient cannot be followed up, the final day of the last examination before the patient became unreachable will be used as the cutoff date. Safety Evaluation Items Adverse events during the observation period Definition: The proportion of study subjects who experienced adverse events among the number of study subjects excluding those who did not receive any study treatment among all registered patients. The severity (Grade) of the observed adverse events is the worst Grade of CTCAE v5.0 during the observation period. Percentage of complications Definition: Percentage of complications (fractures, muscle injuries, hematomas) occurring during the study period | — |
Contacts
Public ContactWataru Saho
Kobe University Hospital
Outcome results
None listed