UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of walking exercise by Nordic pole on the aerobic performance for stroke patients
Title of the study (Brief title)	The effect of walking exercise by Nordic pole on the aerobic performance for stroke patients
Region	Japan

Condition
Condition	stroke
Classification by specialty	Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The stroke patients that are outdoor walking as a subject in the lower limbs brace and t-shaped cane in everyday life, a total of gait training (1 day at the slow speed of 1 hour per day using a conventional t-shaped cane and Nordic pole the number of steps is 5000 steps the target) three times a week, the difference between the effect of a total of 8 weeks of gait training, are evaluated by the 6-minute walk test, which was fitted with a portable breath gas analyzer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	After 8 weeks training, pain and numbness of the hand using the visual analogue scale, average walking speed, walking distance, number of steps, average heart rate and average V02/body weight/min of 6 minutes walking test
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Using the t-cane, three times a week, one hour per day, is performed a total of 8 weeks of training. They use a t-cane in everyday life during walking.
Interventions/Control_2	Using the Nordic pole, three times a week, one hour per day, is performed a total of 8 weeks of training. They use the Nordic pole in everyday life during walking.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	stroke patients who usually use the lower extremity brace and t-shaped cane in everyday life by doing an outdoor walking, the severity of the paralysis of the lower limbs is Brunnstrom stage 3, 4.
Key exclusion criteria	Patients who suffers from walking due to cardiopulmonary or musculoskeletal diseases. Patients who take a medicine that affect the exercise stress. Patients participating in other clinical research within registered 28 days prior to.
Target sample size	40

Research contact person
Name of lead principal investigator	Hidetoshi Takahashi
Organization	Saitama medical university international center
Division name	rehabilitation medicine
Address	1397-1, Yamane, Hidaka, Saitama
TEL	+81-422-984-4111
Email	taka1959@saitama-med.ac.jp

Public contact
Name of contact person	Hidetoshi Takahashi
Organization	Saitama medical university international center
Division name	rehabilitation medicine
Address	1397-1, Yamane, Hidaka, Saitama
TEL	+81-422-984-4111
Homepage URL
Email	taka1959@saitama-med.ac.jp

Sponsor
Institute	Hidetoshi Takahashi
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	埼玉医科大学国際医療センター（埼玉県）

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 10 Month 07 Day
Anticipated trial start date	2015 Year 11 Month 01 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 01 Month 30 Day
Date trial data considered complete	2018 Year 01 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

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

Management information
Registered date	2015 Year 10 Month 16 Day
Last modified on	2017 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022410