Clinical Trial: Investigation of Responses to Sensory Stimuli for Gait Improvement in Patients with Parkinson's Disease (Japan)

Tokyo, July 12 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058433) titled 'Investigation of Responses to Sensory Stimuli for Gait Improvement in Patients with Parkinson's Disease' on July 11.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Reiwa Health Sciences University

Condition: Condition - Parkinson's Disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to examine the effects of sensory stimulation, based on gait data measured by smart shoes, on gait disturbances in patients with Parkinson's disease (PD). Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Sensory Stimuli(Auditory stimulation using a music feedback system,Somatosensory stimulation using a pneumatic artificial muscle system.)

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1)Diagnosed with Parkinson's disease or related disorders.

2)Aged 20 years or older at the time of obtaining consent. Key exclusion criteria - 1)Patients who are unable to walk and require a wheelchair at all times.

2)Patients diagnosed with severe osteoporosis or with a history of multiple fractures, who may have a high risk of bone fracture in case of a fall during the experiment.

3)Patients diagnosed with severe heart disease.

4)Patients who are unable to understand the study explanation.

5)Patients deemed inappropriate for participation by the principal investigator. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 10 Day Anticipated trial start date - 2025 Year 07 Month 14 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066800

Disclaimer: Curated by HT Syndication.