Effect of Stimulation Frequency in Radial Extracorporeal Shock Wave Therapy on Spasticity Reduction in Chronic Hemiparetic Stroke

JRCT ID: jRCTs042240122

Registered date:11/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Individuals with stroke hemiplegia in chronic phase with spasticity
• Date of first enrollment: 11/11/2024
• Target sample size: 18
• Study type: Interventional
• Intervention(s): The three intervention conditions of 1500 shots (500 shots for each muscle), 3000 shots (1000 shots for each muscle), and 6000 shots (2000 shots for each muscle) stimulation will be performed once for each of the three conditions.

Outcome(s)

• Primary Outcome: Group differences in the immediate post-intervention effects of MAS on elbow flexor muscles

Secondary Outcome

1. Group differences in MAS of elbow flexor muscles after 1 month of intervention
2. Group differences in effect of MAS for wrist flexors and finger flexors immediately after intervention and after 1 month
3. Group differences in AOC, ROM of elbow extension and wrist dorsiflexion, ROM of hand extension, and tendon reflexes of elbow flexors and wrist flexors immediately after the intervention and 1 month after the intervention.
4. Recruitment, enrollment, compliance, and retention rates

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

1. Individuals who have given written consent to participate in this study from the individual or his/her surrogate.
2. Individuals aged between 18 and 90 years.
3. Individuals with stroke hemiplegia in the chronic phase of the disease for at least 6 months after the onset of the disease.
4. Individuals with a MAS of 1+ or higher for elbow flexors, wrist flexors, and finger flexors.

Exclude criteria

1. Individuals with skin lesions in the treatment area
2. Individuals with acute inflammation
3. Individuals with thrombosis
4. Individuals who are pregnant or may become pregnant. 5.
5. Individuals with tumors
6. Individuals with multiple neurological disorders 7.
7. Individuals taking anticoagulants
8. Individuals with pain during voluntary movements in the treated area.
9. Individuals who have received botulinum toxin therapy within 4 months in the upper extremity of the intended intervention
10. Individuals who are deemed inappropriate by the attending physician, the principal investigator, or the principal research investigator and his or her research collaborators.

Related Information

• Primary Sponsor: Otaka Yohei
• Secondary Sponsor: Hirano Satoshi