UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The therapeutic effects of peroneal nerve functional electric stimulation for lower extremity in patients with sub-acute post-stroke hemiplegia: A randomized controlled study(RALLY Study)
Title of the study (Brief title)	RALLY study
Region	Japan

Condition
Condition	Stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To invetigate the effects of gait training with functinal electrical stimulation to the improve the lower-limb fuction and ambulation in convalescent stroke patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	6-minute walk test at baseline and ater 8-week intervention
Key secondary outcomes	10-m walk test; Fugl-Meyer assessment (FMA); modified Ashworth scale (MAS); range of motion; Timed up and go test (TUG); Stroke Impact Scale (SIS); subjective gait analysis; Patient reported outcome measure (PRO), adverse event

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Gait training with functional electrical stimulation (FES) + conventional rehabilitation therapy. Intervention with FES is scheduled 40min/day, five times a week, for 8 weeks.
Interventions/Control_2	Gait training without functional electrical stimulation (FES) + conventional rehabilitation therapy.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Patinets who agree to participate in this study and provode their informed consent; (2) since after stroke wothin 6 months; (3) stroke type is only intracranial hemorrhage or ischemic stroke; (4) inpatients for the rehabilitation therapy; (5) Functional Ambulation Classification (FAC) is 3 or 4; (6) stable general condition; (7) drop foot in walking
Key exclusion criteria	(1) severe heart disease; (2) previous gait disability, such as neurological disease; (3) previous orthopedic disease, such as knee osteoarthritis; (4) severe hepatic or renal dysfunction; (5) severe sensory disturbance or severe ataxia or severe higher brain dysfunction; (6) contraindicated for the electrical stimulation (e.g. patients with a medical implant or implantable medical electrical equipment such as a cardiac pacemaker); (7) severe skin disease; (8) unstable medical condition; (9) patinets whose impairement severlities changed during the study period
Target sample size	200

Research contact person
Name of lead principal investigator	Shuji Matsumoto
Organization	Kagoshima University
Division name	Dept. of Rehabilitation
Address	3930-7 Takachiho, Makizono-cho, Kirishima City
TEL	0995-78-2538
Email	shushu@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	Shuji Matsumoto
Organization	Kagoshima University
Division name	Dept. of Rehabilitation
Address	3930-7 Takachiho, Makizono-cho, Kirishima City
TEL	0995-78-2538
Homepage URL
Email	shushu@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University
Institute
Department

Funding Source
Organization	Teijin Pharma Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 17 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2015 Year 12 Month 12 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 01 Month 17 Day
Last modified on	2016 Year 08 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023782