Tokyo, April 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061223) titled 'Japanese study therapeutic exercise for progressive supranuclear palsy' on April 10.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - National Hospital Organization, Higashinagoya National Hospital
Condition:
Condition - Progressive supranuclear palsy
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The primary objective of this study is to evaluate the efficacy of a 2-week short-term intensive inpatient rehabilitation program in reducing the frequency of falls among patients with progressive supranuclear palsy (PSP).
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - The intervention involves 10 daily sessions of a combined exercise program (80 min/day), including 40 minutes of PT and 40 minutes of OT.
Interventions/Control_2 - Patients will continue their usual home life while maintaining the medical and nursing care insurance services they were receiving prior to the start of the study.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients who meet the criteria for "probable" PSP-Richardson syndrome according to the Movement Disorder Society Evidence-Based Diagnosis of PSP.
Key exclusion criteria - 1.Patients unable to walk 10 meters independently even with the use of a walking aid.
2.Patients with a history of lower limb fracture.
3.Patients with comorbidities or complications that may affect the implementation of this study.
4.Patients with a Mini-Mental State Examination (MMSE) score of 20 or less.
5.Patients who cannot complete the primary and secondary outcome measures.
6.Patients without a caregiver who can monitor the number of falls.
7.Patients deemed inappropriate for study participation by their attending physician.
8.Patients with no history of falls within the past month.
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2024 Year 11 Month 18 Day
Date of IRB - 2024 Year 11 Month 18 Day
Anticipated trial start date - 2026 Year 05 Month 01 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070011
Disclaimer: Curated by HT Syndication.