臨床研究等提出・公開システム

Scientific Title	The effect of cueing device on ADL in patients with Parkinson's disease
Public Title	Cueing for Parkinson's disease

Contact for Scientific Queries	Name	MORIGAKI RYOMA
	Affiliation	Tokushima University
	Address	3-18-15 Kuramoto-cho, Tokushima city
	Telephone	+81-88-633-7149
	E-mail	morigaki.riyoma.1@tokushima-u.ac.jp
Contact for Public Queries	Name	FUJIKAWA JOJI
	Affiliation	Tokushima University
	Address	3-18-15 Kuramoto-cho, Tokushima city
	Telephone	+81-88-633-7149
	E-mail	joji@tokushima-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		July. 26, 2022
Target sample size		26
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	placebo control
	assignment	crossover assignment
	purpose	health services research
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with Parkinson's disease suffering from freeze of gait
	Exclusion Criteria	Patients without freeze of gait.
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Parkinson Disease
Intervention(s)		Proprioceptive stimulation by a cueing device will be applied in a cross-over trial with a one-week washed-out period. Patients with Parkinson's disease are asked to use the cueing device in their daily living for one week. They can use it freely when they have a freeze of gait.
Health Condition(s) Keyword		Parkinson's disease, freeze of gait, adaptivity of daily living
Intervention(s) Keyword		proprioception, stimulation
Health Condition(s) Code		D010300
Intervention(s) Code		D011434
Primary Outcome(s)		PDQ-39, Schwab-England ADL score
Secondary Outcome(s)		gait parameters

Primary Sponsor	Ryoma Morigaki

Secondary Sponsor

Name of Certified Review Board	The ethical committee of Tokushima University Hospital
Address	2-50-1 Kuramoto-cho, Tokushima city, Tokushima
Telephone	+81-88-633-7958
E-Mail	brinshoshienk@tokushima-u.ac.jp

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none