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

JRCT ID: jRCTs032230717

Registered date:19/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Spasticity due to cerebrovascular disease, cerebral palsy, and spinal cord disorders
• Date of first enrollment: 19/03/2024
• Target sample size: 90
• Study type: Interventional
• Intervention(s): Radial shockwave therapy will be administered to the muscles with spasticity at one-week intervals for a total of four sessions.

Outcome(s)

• Primary Outcome: 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 Outcome

(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).

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude criteria

(1) Patients with skin lesions around the targeted muscles.
(2) Patients with scheduled Botulinum toxin injections during the study participation period.
(3) Patients with plans to change the type or dosage of oral medication for spasticity during the study participation period.
(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.

Related Information

• Primary Sponsor: Ogata Toru
• Source(s) of Monetary Support: SAKAI Medical Co.,Ltd.