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The evaluation of the effect of radial shockwave therapy on the muscles with spasticity

The evaluation of the effect of radial shockwave therapy on the muscles with spasticity

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032230717
Enrollment
90
Registered
2024-03-19
Start date
2024-05-29
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spasticity due to cerebrovascular disease, cerebral palsy, and spinal cord disorders spasticity

Interventions

Radial shockwave therapy will be administered to the muscles with spasticity at one-week intervals for a total of four sessions.

Sponsors

Ogata Toru
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Public ContactMika Kobayashi

The University of Tokyo Hospital

kobayashimi-reh@h.u-tokyo.ac.jp+81-3-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026