Spasticity due to cerebrovascular disease, cerebral palsy, and spinal cord disorders spasticity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients with spasticity presenting a Modified Ashworth Scale (MAS) score of 2 or higher at the time of obtaining consent. (2) Patients diagnosed with one of the following conditions: a.Cerebrovascular disorders, b.Cerebral palsy, c.Spinal cord disorders. (3) Patients with an onset of the underlying condition of six months or more. (4) Patients aged 12 or older at the time of obtaining consent. (5) Gender: No restrictions. (6) Patients who have received sufficient explanation regarding participation in this study, have understood it adequately, and have provided written consent from the research subject or a legal representative based on their own free will. (7) Patients who can attend outpatient visits according to the research implementation schedule.
Exclusion criteria
Exclusion criteria: (1) Patients with skin lesions around the targeted muscles. (2) Patients with scheduled or administrated Botulinum toxin injections from 2 weeks before to 8 weeks after the start of the treatment. (3) Patients changed or with plans to change the type or dosage of oral medication for spasticity from 2 weeks before to 8 weeks after the start of the treatment. (4) Patients who are pregnant or possibly pregnant. (5) Any other individuals whom the principal investigator or participating physicians have deemed unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Modified Ashworth Scale (MAS) score. (calculated by subtracting the value at the treatment initiation day from the value at 8 weeks after the start of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Change in joint range of motion from the treatment initiation day (at 1, 2, 3, 4, 8, and 12 weeks after treatment initiation). (2) Change in walking speed from the treatment initiation day (at 4, 8, and 12 weeks after treatment initiation). (3) Change in center of pressure path length from the treatment initiation day (at 4, 8, and 12 weeks after treatment initiation). (4) Change in Modified Ashworth Scale (MAS) score from the treatment initiation day (at 1, 2, 3, 4, and 12 weeks after treatment initiation). (5) Change in Fugel Myer Assessment (FMA) score from the treatment initiation day (at 4, 8, and 12 weeks after treatment initiation). | — |
Contacts
The University of Tokyo Hospital