Tokyo, Feb. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060753) titled 'Rehabilitation therapy for lower limb spasticity in subacute sclerosing panencephalitis: A single-case experimental design study' on Feb. 26.
Study Type:
Interventional
Study Design:
Basic Design - n-of-1
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Ogura Hospital
Condition:
Condition - Lower limb spasticity, Subacute sclerosing panencephalitis (SSPE)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Subacute sclerosing panencephalitis (SSPE) is a rare, fatal disease, yet evidence for rehabilitation in long-term survivors is lacking. This study aims to evaluate the efficacy of rehabilitation for lower limb spasticity in these patients. The intervention involves botulinum toxin therapy to assess initial improvement, followed by a home-based vibration stimulation program to confirm its additional effects on spasticity suppression.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Botulinum therapy
Eligibility:
Age-lower limit - 60
years-old
=
Gender - Male and Female
Key inclusion criteria - A patient with subacute sclerosing panencephalitis presenting with gait disturbance due to lower limb spasticity
Key exclusion criteria - Those unable to communicate, those in poor overall health, and others deemed unsuitable by a physician
Target Size - 1
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 02 Month 13 Day
Date of IRB - 2026 Year 02 Month 25 Day
Anticipated trial start date - 2026 Year 02 Month 26 Day
Last follow-up date - 2026 Year 12 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069521
Disclaimer: Curated by HT Syndication.
